CITI- GLP

A technician is preparing solutions that will be administered to test and control rats. For the test group, the protocol instructs the test article to be prepared as a 50 percent weight-to-weight (w/w) solution in corn oil. What is this solution's composition?

30 grams of test article and 30 grams of corn oil The choice of 30 grams of test article and 30 grams of corn oil is correct. In a w/w solution, each component is weighed to reflect the desired ratio (50 percent in this example). The 30 grams of test article and 30 mL of corn oil represent a 50 percent weight-to-volume solution.

A graduated cylinder made of glass is an example of a common piece of laboratory equipment that provides measurement data but cannot be calibrated by technical staff. What standard procedure would assure it is suitable for use?

A visual check to assure the cylinder is clean and its markings are easily visible Although this equipment has already been calibrated, it must be clean or have clear markings to be suitable for use. The substance being measured could be contaminated by residue left in the cylinder and accurate measurement could be difficult if its demarcations are unclear. An SOP for safety purposes might advise gloves, but this requirement does not affect the equipment's suitability for use.

Why is the use of animals in research and testing necessary?

A whole biological system provides the best information. Alternatives will continue to reduce the number of animals necessary, but a whole biological system still provides the best information to researchers. Human research is permitted by law but not within the GLP regulations' scope. The EPA and FDA accept some alternative means of predicting adverse effects and/or toxicity, but their effectiveness is limited to certain compounds.

Which of the following facilities would the EPA potentially inspect?

A facility that evaluates crop pesticides in outdoor research plots The EPA would inspect the outdoor facility that tests crop pesticides in outdoor research plots. The other choices fall under the scope of FDA oversight.

Testing facility management must develop processes to ensure the validity of raw data. Which of the following pieces of equipment does not generate any raw data?

A locked freezer that is used to store samples of blood from study animals The freezer does not generate any raw data. The various devices and instruments used in a particular facility generate the raw data. These devices and instruments may be simple or complex depending on resources or other factors. All the data-generating equipment must be checked for accuracy and recalibrated, if necessary.

Why is a contract testing facility that uses laboratory animals or provides analytical services potentially subject to FDA or EPA inspection?

A protocol may specify that the FDA or EPA will receive the final study report A contract testing facility will typically offer its services to a wide variety of clients. Typically, it is not a study's sponsor, nor does it submit the final study report. The study's sponsor must inform the contract testing facility of any intention to submit the study results to FDA or EPA and list the appropriate agency in the study protocol.

The study protocol will require many specific operations and methods for all aspects of study conduct. Standard operating procedures (SOPs) will describe how the study conduct operations and methods are to be done. How is the relationship of SOPs to the protocol best understood?

A protocol supersedes SOPs. A protocol always supersedes SOPs. Therefore, if the study director determines that the facility's SOPs are inadequate for a study, they can describe the necessary processes in the protocol. When a deviation from an SOP occurs, it should be documented as soon as it is detected. In addition, an SOP deviation must be communicated to the study director (just like a protocol deviation).

What did the negative findings from the G.D. Searle and Industrial Bio-Test Laboratories (IBT) cases reveal?

A wide range of uncontrolled, unsupervised study and facility operations including major lapses in the integrity of data scientific practices The negative findings from the G.D. Searle and IBT cases revealed a wide range of uncontrolled, unsupervised study and facility operations including major lapses in the integrity of data scientific practices.

What would a GLP memorandum of understanding (MOU) between an OECD-member country and the U.S. permit?

Acceptance of final reports and data that were conducted in either country under their applicable GLP regulations OECD-member countries do not need to have the U.S. FDA or EPA visit their facilities for inspection because the declaration of GLP compliance in the final report is sufficient. While MOUs promote free trade, their purpose is to document agreement on the sufficiency of GLP standards to provide sound data.

Regarding commercial archives, the U.S. Food and Drug Administration (FDA) __________.

Allows contracting with such facilities to provide a repository for all material to be retained Commercial archives are permitted and discussed by the FDA and Environmental Protection Agency in their respective regulations. Generally, when a commercial archival facility is being considered, management and/or the quality assurance unit (QAU) will inspect the facility in advance to ensure that the Good Laboratory Practice (GLP) requirements will be met. The specific points in all SOPs are determined by testing facility management, not the regulatory agencies.

A report has been made final (signed and dated by the study director). What is required to make a significant change to its contents?

An amended final report An amended final report is required for a significant change. Any changes must be clearly identified. If the facility's standard operating procedure required the quality assurance unit to perform another audit of the report's changes, a revised QA page would be appropriate to document their work. No amendment or deviation to the protocol is required.

During the conduct of a study, a group of rats was to be observed hourly for four hours following the time of dosing. The administration of the test article occurred at 8:30 a.m. All the rats appeared active and healthy for the first three hours. Due to an important staff meeting scheduled by management during the lunch hour, the study technician performed the last observation at noon. What protocol requirement was not met and what will be needed for Good Laboratory Practice (GLP) compliance?

Animal observations were to be made hourly for the first four hours. GLP compliance requires the study director to issue a protocol deviation noting any impact on the study. The study director should prepare a protocol deviation. It may have been critical to this study to adhere to the hourly schedule. No flexibility was built into the instruction for the timing of observations. Ideally, the technician could have asked to be excused from the staff meeting. Management would be aware of the need to adhere to protocol requirements.

During a study, errors made when collecting raw data or supporting data:

Are not unusual and so standard operating procedures (SOPs) for handling corrections will be established by management to guide Good Laboratory Practice (GLP) compliance Data collection errors are not desirable, but they are not unusual. Patience and taking the time to understand the task will help to improve performance. An expectation of 100 percent perfection will usually result in employees covering up errors to avoid punishment. The use of teams and/or scribes is common, usually for efficiency, but an error still can occur during the procedure. Anyone can make an honest mistake. The U.S. Food and Drug Administration's GLP regulations were implemented in response to finding deliberate fraud and scientific misconduct. Quality control measures are valuable and provide the advantage of having a fresh eye on the data to detect errors but will not eliminate them. Providing training on how to properly report and/or correct errors is more realistic than expecting that none will occur.

What is the word used to describe the kind of personnel who shall enter the archives?

Authorized Only authorized personnel shall enter the archives. Although the archivist is responsible, backup archivists can be designated as authorized to enter the archives. The archivist(s) position is commonly included as part of the facility's organizational chart to emphasize the limited access.

What does the FDA term "nonclinical laboratory study" exclude?

Basic exploratory studies carried out to determine whether a test article has any potential utility Basic exploratory studies that help determine whether a test article has potential utility are excluded. An example is a "range-finding" test done using a few mice or rats and one or more dosage levels to determine the approximate degree of toxicity. This kind of test helps the study director to select an appropriate dosage level for a full study using animals. The FDA is responsible for the oversight of all the other listed study types when they are submitted for consideration. Therefore, they are not excluded from GLP compliance.

Regarding archives, the Organisation for Economic Co-operation and Development's (OECD) "Series on Principles of Good Laboratory Practice and Compliance Monitoring" is __________.

Covered in a specific document (No. 15) that is to be used in conjunction with the OECD GLP guidance, which also provides some guidance for archival This important topic is covered in detail within monograph No. 15. It is also mentioned in the OECD's GLP guidance. OECD provides useful guidance for the generation and handling of electronic data.

A technician performing a survey of a treated plot of tomatoes is not sure if he sees a fungal disease on the leaves or if the discoloration could be from the test substance application three days ago. The technician's facility has a standard operating procedure (SOP) that allows photographs, which help with descriptions in field studies. The technician takes a picture using his cell phone because the camera required to be in the field kit is not present. He then describes the condition of the plants on the data form used for the survey. In this case, is the picture or the handwritten entry on the data form raw data?

Both are raw data because they were original, direct records. The picture and the handwritten entry represent raw data. The notes were necessary to explain the photograph and identify the study. The definitions found in the U.S. Food and Drug Administration (FDA) regulations and Environmental Protection Agency (EPA) regulations state that raw data "may include photographs." Field studies are subject to the EPA regulations. The study director will need to generate an SOP deviation for the cell phone photograph. The study director should document that the camera in the field kit was unavailable and allow an emailed and printed version of the photograph to serve as a true copy for this particular study.

An animal care technician is about to prepare a bucket of solution to pour into a cage-cleaning device. The plastic jug of detergent is fitted with a pump dispenser set to measure out the required two ounces. The technician sees a large crack along the side of the pump, which is allowing some leakage of the detergent. There is a set of measuring cups in the equipment bin. What should the technician do to accurately prepare the solution so cage cleaning can proceed?

Check the standard operating procedure (SOP) for alternative measuring equipment. Ask a supervisor for direction if there is not an SOP. The vivarium and laboratory operate under written procedures to ensure consistency in everything that potentially affects the studies or the animals. Ordinary operations like cage sanitation directly affect animal health and welfare. Jug pumps are set to measure a given amount when properly depressed, so cracks and loose seals affect accuracy. In this case, the technician should check the SOP for alternative measuring equipment. If there is not an SOP, they should ask a supervisor for direction.

While an inspection of a critical phase is being conducted, it is typical for quality assurance (QA) personnel to __________.

Closely observe the procedure while creating minimal distraction QA personnel will typically need to closely observe procedures and data generation while being careful to avoid interference. Although questions may be raised if the QA personnel feel it is necessary, they should avoid drifting into directing a procedure. Usually, the inspection is a quiet time of observing, examining materials, reviewing forms, and documenting findings in keeping with QA standard operating procedures. QA personnel may be accompanied by the study director or visiting clients during an observation.

"Study plan" and "study protocol" are __________.

Completely interchangeable terms These terms are completely interchangeable. OECD uses the term "study plan," whereas FDA and EPA use the term "study protocol" to describe the controlling document for an individual study.

A particularly large study requires the collection of blood samples from mice at three intervals over the course of six months. Due to the high skill level and time commitment required, management decides to have a qualified company perform this part of the study. The contract technicians will come in to do the collections when scheduled, and the samples will be left at the sponsor testing facility for analysis. In order to "assure that personnel clearly understand the functions they are to perform," what is the most logical thing that management should request from this study partner?

Copies of the technical team's training records When companies partner with other companies to accomplish any GLP-related task, management should be provided with training records to remain GLP compliant. Therefore, written documentation that each technician was fully trained and found to be competent by their facility's management would be the most logical thing to request. These training records would become part of the project's study file. The study director, QAU, or management could observe the entire process, but this would not provide sufficient proof or documentation of the technicians' training.

Quality assurance (QA) personnel perform audits of __________.

Draft and final reports against the study raw data and the protocol The term "audits" generally infers a comparison of documents and data to determine consistency, accuracy, and completeness, as well as regulatory compliance. QA personnel audit study and supporting raw data; general facility records, such as training documentation, protocols, and changes to protocols and standard operating procedures; and the draft and final versions of reports prior to their submission to the applicable regulatory agency.

What is the purpose of standard operating procedures (SOPs) in the context of GLP?

Describe study methods for ensuring the quality and integrity of data SOPs describe study methods for ensuring the quality and integrity of data. Clearly written, management-approved SOPs help facilities achieve GLP-compliant laboratory operations; maintain equipment; and accomplish the quality system goals of consistent output, verification, and control.

For each testing facility that archives its own raw data, the procedures that describe how it will be done are __________.

Determined to be adequate by testing facility management and described in standard operating procedures (SOPs) Testing facility management must provide adequate resources and approve standard procedures for all archival functions.

Which of the following best describes the reason health precautions and sanitation issues are addressed in the GLP regulations?

Disease transmission is possible in laboratory settings, which poses a concern for personnel and organizations. Health precautions are obviously important for personnel, especially when working closely with animals on a daily basis. Disease transmission is possible when working directly with non-human primates such as monkeys or chimpanzees (for example, non-human primates could transmit hepatitis to humans and are susceptible to catching numerous diseases from humans). Technical staff who work with other species such as rodents or rabbits can experience allergic or sensitization reactions over time. In addition, humans can transmit pink eye to animals. Therefore, personnel must follow all sanitation and health instructions carefully and consistently.

Which of the following is a major difference in the way the FDA conducts its testing facility inspections in the U.S. when compared to the EPA?

FDA may not provide prior inspection notice In the U.S., FDA generally does not announce its intention to inspect. Given the nature of the related studies and the desire to have critical people available, EPA generally provides a ten-day inspection notice. Both the FDA and EPA have the same level of authority despite the differences in their methods for inspection.

Each individual engaged in the conduct of or is responsible for the supervision of a nonclinical laboratory study shall have __________.

Education, training, and experience, or a combination thereof The FDA regulations state that "each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions" (21 CFR 58.29(a)). It is not always necessary for personnel to have a college education to obtain a position in nonclinical laboratory or vivarium settings. Over time, personnel gain specific experience. In addition, continuing education enables personnel to advance their professional capabilities.

The GLP regulations state that equipment shall be adequately inspected, cleaned, and maintained. What kind of equipment must also be adequately tested, calibrated, and/or standardized?

Equipment used for the generation, measurement, or assessment of data. The GLP regulations require that equipment used for the generation, measurement, or assessment of data be adequately tested, calibrated, and/or standardized. While the inspection, cleanliness, and routine maintenance of all equipment in research and testing settings is obviously important, the quality and integrity of raw data is a primary focus in the regulations.

A study director is often free to address quality assurance (QA) findings under certain conditions as they see fit. This may be allowed when the __________.

Finding does not relate to regulatory compliance Findings on inspection or audit reports should relate to the degree of regulatory compliance, with an expectation of correction or explanation from the study director. Communication must be clear and tied to the regulations. QA personnel should identify findings and comments based on the situation. If the procedure's efficiency appeared to be compromised by lack of employee training, that qualifies as a GLP-related finding. The study director may decide to become more involved with the study oversight, and the GLP regulations require management to provide appropriate training. Management, rather than the study director, is a better audience for general comments about safety or suggestions regarding efficiency. QA reports of noncompliant GLP findings will require a response.

What does OECD's term "experimental starting date" mean?

First date that any study specific data are collected The experimental starting date is the first date that any study specific data are collected. A good example would be a technician determining the specific gravity of a liquid test article for use in calculating the animal dose amounts, in preparation for the following day's work. The study starting (initiation) date is the date when the study director has signed the study plan or protocol. The EPA uses the term "experimental start date" as the first date that the test substance is applied or administered to the test system.

As the G.D. Searle and IBT cases demonstrate, what is an essential difference between research fraud and error?

Fraudulent actions are intentional As anyone can make a mistake, the essential difference is the intention to commit fraud. The operations in regulated research are especially vulnerable to hazards from new or poorly trained employees, work pressure, or miscommunication, making errors more likely. Fraud may be detected by quality assurance (QA) personnel, peers, or the study director.

For a study to be submitted to the Environmental Protection Agency (EPA), during what period of an active study is the animal room environmental information included in the final report?

From the experimental start date to the experimental termination date The experimental start date to the experimental termination date represents the EPA definition of the time between the initial administration/application of the test substance to the test system and the conclusion of the in-life phase of a study. When laboratory animals are ordered from vendors, a large number are generally requested because not all will be acceptable for testing. The environmental information would still be collected from quarantine or holding rooms but does not require reporting.

In addition to training and standard operating procedures (SOPs), a requirement for efficient operation between animal care and technical staff is:

Full communication Full communication is the correct choice because there is no guarantee that all employees will be able to attend all meetings. Communication, such as asking questions, using clear speech, and active listening to verify that instructions are understood, provides the easiest path to efficient operations. It also creates a higher level of teamwork, self-esteem, and collective pride in doing a job properly.

Which of the following is accurate regarding the scope of the FDA's GLP regulations for nonclinical research and testing?

Includes any safety study submitted to the FDA that supports applications for research or marketing permits for regulated products FDA investigators may assist the EPA in inspection duties, but this is not part of the scope of the FDA GLP regulations. FDA is only responsible for what is listed in the scope of its regulations. This includes any safety study submitted to the FDA that supports applications for research or marketing permits for regulated products.

Raw data includes photographs and other types of data collected during a study. When taking photographs with a digital camera, in addition to the image itself, what else would be required for GLP compliance?

Inclusion of the metadata and the unique study identification The inclusion of the unique study identification is always necessary to relate raw data to a specific study protocol or report. While the other three answers are partially correct, the metadata for digital photographs generally does not include the specific study identification.

How were FDA investigators first alerted to problems related to nonclinical laboratory study conduct?

Inconsistent and/or unexplained entries in data submitted to the FDA A high level of inconsistency between what scientific investigators found and what was erroneously reported alerted the FDA. This resulted in "for cause" inspections at several facilities, even reviews of color-additive testing performed in FDA facilities. The FDA summarized these defects in its preamble to the 1976 proposed GLP regulations.

What is the primary responsibility of a quality assurance unit (QAU)?

Independent monitoring and reporting any findings to management The QAU always must function independently. QAU personnel cannot assist or direct the technical staff during a procedure. Their inspection or audit reports are submitted to management and the study director, not to the FDA. During an inspection of a facility, FDA will assess if the QAU's procedures and operations are compliant with the GLP regulations.

A facility's animal care standard operating procedure (SOP) requires the replacement of water bottles attached to rat cages every three days. However, a study technician has posted a direction on a rack to leave the bottles on cages for weekly measurement of water consumption. The direction notes that it is a "protocol instruction." As a very experienced animal care technician, you see that the bottles chosen for the rack are too small and will not hold five days' worth of water. What should be done?

Inform the study director immediately to report the problem and verify the posted instructions. The study director should be informed as soon as possible and the posted instructions should be verified. This action is best because it ensures the correction will be made in accordance with the study protocol. Teamwork is important in GLP work because each study may have different requirements.

The FDA's definition of "application for research or marketing permit" illustrates the wide range of activities the agency regulates. Which of the following is not covered in this definition?

Insecticides produced for use in home gardens or flowerbeds The FDA does not regulate food grown in home gardens. The EPA requires that home garden insecticide products be evaluated for safety when used and that any residue left from their use is not toxic to consumers.

The U.S. Food and Drug Administration (FDA) or Environmental Protection Agency (EPA) does not dictate any standard for the number of quality assurance (QA) inspections of each nonclinical laboratory study. Instead:

Inspections must be adequate and of a sufficient number to ensure study integrity Because the range of study types and protocols is so wide, and circumstances can change, study inspections must be adequate and done as often as directed by the QA standard operating procedures. There is no method for inspecting or auditing described in the regulations. The quality assurance unit does not communicate their inspection or audit results to the FDA or EPA, but they do communicate them to management and the study director.

A facility housing nonhuman primates will be adding fresh fruit to the animals' diet. What will an Animal and Plant Health Inspection Service (APHIS) inspector be looking for when inspecting the facility?

Moldy or soiled fruit in cages or feeders and refrigeration of fruit if necessary for storage. APHIS inspectors will want to see that no soiled or moldy fruit remains in the animal housing or feeders and refrigeration is present for stored fruit if necessary for storage. There is no requirement for organic produce (although a protocol may require this).

Which document is the most influential in assigning the number of personnel for the timely and proper conduct of a study?

Protocol The protocol describes exactly what needs to be done and when to conduct the study with accuracy and efficiency. SOPs are not only limited to study operations. They also govern quality assurance unit (QAU), vivarium, and data management activities.

The records retained by the quality assurance unit (QAU), including inspection and audit reports, are not "raw data" as defined by the regulations. According to the U.S. Food and Drug Administration (FDA) regulations (21 CFR 58.195) on the retention of records, the QAU __________.

Is not free to discard any of the study-related quality assurance (QA) inspection or audit reports Study-related QAU audit or inspection records, including the final protocol and audit/inspection notes, should not be discarded. These records may be required at a later time and should be archived in a designated section for preservation. This is true if the study report was submitted or the study director canceled the study.

The EPA's definition of "application for research or marketing permit" illustrates the range of activities the agency regulates. Which of the following is accurate regarding the scope of this definition?

It covers testing that would permit emergency use of a pest control product in agriculture The EPA's definition of "application for research or marketing permit" includes an application of an exemption under FIFRA section 18. This exemption allows for the short-term use of a chemical on marketable crops while the supporting studies or data mining activities are being conducted (data mining means the researchers use other published and accepted research to support the petition). An exemption is necessary when a new pest, such as an insect, is causing grave damage to crops and a temporary means of control is needed to prevent a wider infestation.

A study protocol requires a crystallized test article to be uniformly mixed into distilled water. What is meant by "uniformly?"

It means that homogeneity studies have been conducted to assure the mixing procedure provides a uniform mixture. A uniform mixture in distilled water would not have any visible sediment of the crystallized test article after mixing. However, it is not always visible to the naked eye whether a mixture would be considered a true solution or a suspension. Therefore, analytical tests are required to substantiate that the mixing procedures provide a uniform, homogeneous solution. When problems are encountered, such as finding that the test article does not fully dissolve into the water, the study director needs to be informed.

Which response is not a characteristic of an FDA inspection of a testing facility?

It must always be communicated to the facility well in advance Contrary to EPA's typical practice, FDA does not generally contact the facility prior to an inspection. As soon as a facility submits a final report claiming FDA or EPA GLP compliance, it may be scheduled for an inspection to verify the integrity of the reported results. A facility may also be inspected once it has submitted an application for a new product. Once the first inspection has been conducted, it is common for the FDA or EPA to place the facility on a routine inspection schedule. However, the FDA may also conduct "for-cause" inspections, whether triggered by a whistleblower or by some other action such as suspicious or inconsistent findings in final reports.

A technician is recording rodent body weights on a form and notices a fairly large weight loss for one animal since the last weighing period. Following the instructions received during training, the technician checks the animal's water source and finds that the valve is not operating properly. What might this situation represent?

It represents a situation where additional raw data will be necessary to describe the unforeseen circumstance and the remedial action taken, along with the need to notify the study director. The situation represents an unforeseen circumstance, so documentation of the problem and what was done provides "additional raw data" to provide important information. The study director should be notified as soon as possible because the weight loss was probably caused by a lack of water and not the test substance. Such an assumption is logical, but to be sure, the study director might decide to add an additional weighing of the animal on the following day. In this situation, the action of the technician reflected proper training. This evidence of attention to detail, taking responsibility, and teamwork is essential in nonclinical laboratory settings.

Which of these statements is most true about laboratory animal research?

Laboratory animal research is heavily regulated and facilities are routinely inspected. Laboratory animal research is both heavily regulated and the personnel and facilities are routinely inspected by the quality assurance unit (QAU) and federal agencies including the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). Federal laws also regulate any potentially or actually painful procedures. Both technical and animal care staff are highly trained, educated, and concerned about animal welfare issues. While some alternatives exist, they cannot replace a whole living system for evaluating possible responses.

What is the primary hazard for the long-term archival of paper?

Loss of data integrity from the destruction or deterioration of the paper The primary hazard for the long-term archival of paper is the loss of data integrity due to the destruction or deterioration of the material. In addition to flooding, paper data can be damaged by infestations of mice and certain insects, prolonged humidity, or fire. Fire suppression for paper storage is best done by mechanical or chemical means, so a large volume of water does not add to the problem. The hazard of accidentally discarding older project data must be addressed by having a system of indexing and archival maintenance.

In a final report for submission to the U.S. Food and Drug Administration or Environmental Protection Agency, the individual reports of a contributing scientist or other professionals __________.

Must be appended to the study director's final report. Individual reports of a contributing scientist must be appended to the study director's final report. These reports may be archived at any location if it is disclosed in the final report and must be appended exactly as presented. Appending a summation of a contributing report or simply including an opinion in the body of the final report does not meet the regulatory requirement.

Because of an error in labeling the strength of a test article provided to a contract testing facility, the toxicity of the test article was too great, causing the death of nine of the ten mice in the study. The study director prepares a protocol amendment to terminate the study and presents the raw data for archival. Have the regulatory requirements been satisfied?

No, because a final report also must be prepared for terminated studies. An approved protocol and the test article had been administered to the test system, so a final report is still required. The unforeseen circumstance of the mislabeled test batch made it necessary to prepare a protocol deviation to describe the problem and a protocol amendment to terminate the project. The final report will be brief but must describe exactly what happened. Under no circumstances should the study be re-started using the original study identification shown in the protocol. Facility standard operating procedures will describe the accepted procedure for assigning a unique study identification. The test article was not as described in the protocol, but the testing facility could only have known that once its toxicity was demonstrated. The other actions taken by the study director are compliant.

A two-year study on rodents ends, and all the raw data are transferred to the report preparation department. The report writer makes some corrections to the report after the quality assurance unit (QAU) reviewed the first draft. The report writer then transfers the raw data to the archivist. Is this facility operating in compliance with the Good Laboratory Practice (GLP) requirements for raw data archival?

No, the transfer of the raw data at or during the close of the study is the study director's responsibility. As the sole point of study control, the study director is responsible for transferring the raw data to the archives "at or during the close of the study." While it does not matter who transfers data for report preparation, the situation described cuts the study director out of the process.

Once management has approved an SOP for a balance that will be used to weigh mice or rats and technicians are trained to perform the procedure with the equipment, what else will be necessary for GLP compliance?

Personnel must verify that the operations occurred as directed in the SOP, so appropriate documentation will be necessary whenever the equipment is used. Documentation that verifies the SOP was followed is necessary whenever any operator uses the equipment. The study director or a technician might be involved in the weighing of animals, but the SOP will guide their use of the equipment.

The U.S. Food and Drug Administration (FDA) regulations require the retention of all raw data, documentation, protocols, final reports, and specimens. What are typical specimens from a complete necropsy?

Preserved tissues, organs in fixative and/or wax blocks, and microscopic slides A complete necropsy, distinct from a simple gross necropsy, will be fully described in the study protocol. Typical specimens include preserved tissues, organs in fixative and/or wax blocks, and microscopic slides prepared to enable histological evaluation. In addition to the required organs and tissues, any abnormalities found would also be preserved. All the remaining choices are raw data.

In the U.S., quality assurance (QA) inspections of activities are connected to individual studies. When following the Organisation for Economic Co-operation and Development (OECD) guidance:

Process-based inspections may suffice for a number of short-term repetitive studies, and individual studies do not need to be inspected. The OECD allows the QAU to perform these representative inspections, allowing process-based inspections to ensure compliance for more than one short-term repetitive study. When auditing raw data and reports, the QAU focuses on the individual study.

What is the primary purpose for the retention of nonclinical laboratory study raw data and other associated records in an archive?

Protect the records from loss or damage for at least the time period required by the study protocol and/or Good Laboratory Practice (GLP) requirements For GLP compliance, the final report must reflect the raw data used to prepare and present all its contents. Investigators from the FDA or EPA may want to compare it to the submitted final report for verification of the report's accuracy. An orderly system for retrieving the complete study file must be observed to facilitate this and any other future reference to the raw data and/or the final report. Archives, trained archival staff, standard operating procedures, and limitations on archival access are typical resources and practices. Archival does not prevent the addition of information or data after submitting the final report. There are circumstances where this might legitimately occur, and the archivist would document the addition. In keeping with the study protocol, the sponsor can take possession of the material at any time before or after archival.

A study protocol requires that rabbit body weights be collected during a dermal toxicity study on Days 0, 7, 14, and 21 (study termination). After the collection of weights on Day 7, the technician notes that all the females have lost weight and some males' weight gain was minimal. The technician informs the study director who then reviews the raw data. As a result, the study director decides to add a weighing interval on study Day 10. What should the study director now prepare?

Protocol amendment The study director should prepare a protocol amendment to authorize another weighing interval. The reduction in animal weight gain could represent an effect from the dermal application of the test article. This route of administration often results in delayed effects because the article is absorbed more slowly than with oral, inhaled, or intravenous administrations. Because the quality assurance unit will receive a copy of the protocol amendment, the study director will not need to provide them with a specific notification.

What is the difference between "raw data" and "supporting data?"

Raw data are collected directly from study operations according to the protocol and standard operating procedure (SOP) instructions. Raw data are any laboratory worksheets, records, memoranda, notes that are the result of original operations, and activities of a study. Supporting data represent general facility, animal husbandry, animal receipt, facility maintenance, and other information that will affect many studies. Animal care staff is also "trained" and may assist technicians in ways that generate raw data. Both raw data and supporting data may be documented using manual or electronic systems. Original supporting data are also safely stored in the archives at some point.

Once the experimental termination date is reached for a study being submitted to the U.S. Environmental Protection Agency (EPA), its protocol _________.

Remains in force because the study is not completed until the final report is signed The EPA regulations include the term "experimental termination date," which is not the same as the study completion date. The FDA does not utilize this term, but the same answer would apply. For both agencies, a study is completed when the study director signs and dates the final report (in other words, the study termination date). The QAU retains its copy of the protocol because auditors will need to refer to it and any subsequent changes during their audits of raw data and the draft/final reports. While some facilities may archive certain raw data for long studies to increase document security, the protocol will still be needed for reference. An approved nonclinical study protocol must include the list of records to be collected during the study to provide instruction to personnel.

During an EPA or FDA inspection, what should the technical staff do?

Respond briefly to any direct questions asked of them or state they do not know the answer to the question If technical staff are asked questions by an inspector, they should either respond or state they do not know the answer. They may not have that authority to reply, for instance, or may not yet have been trained to perform the procedure that is being examined. Simply put, there should not be any attempt to make up or guess an answer. Ethics, honesty, and common sense should prevail. As much as possible, the facility should operate normally when the FDA or EPA inspection team is on-site. One reason for informing staff of the presence of an inspector is to remind employees that anything noted or overheard during the inspection can be made part of the evidence collected. Nonetheless, there is no reason to deliberately avoid the inspectors. It is not the appropriate setting to report supervisory or other problems, which should always be handled internally using proper reporting channels, beginning with an immediate supervisor. SOP manuals always should be close at hand in work areas to allow routine use and reference by staff.

In a nonclinical testing facility, the vivarium supervisor decides to switch to a new cleaning product that promises to be effective and environmentally friendly when cleaning the animal room floor. As the supervisor reviews the safety data sheet (SDS), they see that the product can be used in either cold or hot water. The standard operating procedure (SOP) for cleaning floors at the facility directs the use of only hot water for this task. The supervisor sends management a copy of the SDS and suggests an edit to the SOP. What should management do to accomplish the company's goal of keeping its quality system current?

Revalidate the cleaning process with cold water to assure it provides the level of sanitation needed. Once validated, the SOP should be revised, and personnel should be trained. Cleaning procedures must be "validated" (in other words, prove they work) before implementation. Changes to an SOP should not be made until the procedure is proven to work in accordance with the facility's requirements. Just because a label indicates that a cleaning agent can be used in cold or hot water does not mean that such use meets the requirements of the research being conducted at the facility.

Nonclinical research and testing refers to safety studies performed using __________.

Several species of animals, plants, and organisms Nonclinical research refers only to research that does not involve humans. While rodents are commonly used, the possible range of products tested is vast, and test systems other than rodents may be required.

The quality assurance unit (QAU) is to provide a facility with independent oversight of its Good Laboratory Practice (GLP) compliance. Therefore, their relationship to the facility management __________.

Should be clearly shown by a single line of reporting on the organizational chart Direct reporting to management by the QAU should be documented in the facility's organizational chart to verify its independence. The QAU should not be in a general facility supervisory role or supervised by personnel such as the study directors. The management-QAU relationship should be professional and focused on GLP compliance. Management's attitude toward QAU functions should be supportive, and they should recognize the QAU's importance to corporate success. "Negative" findings only serve as information to be used by the facility management to enable their correction and improvement.

When a testing facility's study report is being inspected by the U.S. Food and Drug Administration (FDA), the targeted raw data and other supporting records __________.

Should remain in the archives until requested because the inspectors will want to see that the archivist can expediently retrieve them The procedures for the archival and retrieval of the stored materials could be inspected. "Expedient retrieval" must be demonstrated because the archived material is expected to be stored in an orderly fashion. The quality assurance unit (QAU) member cannot enter the archives for this purpose unless they are in the process of performing an inspection. The study sponsor should not be impeding inspections by the FDA or Environmental Protection Agency (EPA), but they should be made aware that an inspection has been requested.

If quality assurance (QA) personnel ask a technician a question during an inspection, the response should be _________.

Simple and honest, offering explanation or other information when necessary to explain a situation Technicians should answer questions from QA personnel simply and honestly. They should offer explanation or other information when necessary to explain a situation.

Quality assurance (QA) personnel perform inspections of __________.

Study critical phases and related facility/laboratory operations The term "inspections" generally infers the observation of the study's critical phases and related laboratory/facility actions as they are in progress. Vivarium operations comprise one of several categories of typical facility activity. QA personnel may also inspect archival, analytical chemistry operations, sample receipt, other activities, and outside vendors or partner facilities.

In the OECD guidance, a unique guideline for study directors is _________.

Study directors ensure that computerized systems used in the study have been validated Per the OECD guidance, study directors should "ensure that computerised systems used in the study have been validated." Validation means that testing has been done to ensure that the computerised system performs to its exact specification(s), which is not normally a task for which study directors are qualified. However, they can obtain the required proof that the program or system has been tested and validated.

The EPA has developed a "tolerance" for the active ingredients in the pest control products that are used on food and feed crops. What does a tolerance allow?

Test results to be measured against the allowable level of residue, typically in parts per million, billion, or trillion By having a known level of allowable "residue" of the active ingredient for the agrichemical, analytical tests can confirm the safety, or deny the use, of the test substance on the particular crop. It is not likely that any regulatory body could convince environmental activists to accept the use of chemicals in foods. However, even organic growers must use certain naturally derived substances that are marketed for pest control.

The U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) regulations state that procedures shall be established for handling articles and substances to ensure that there is proper storage; distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage; proper identification is maintained throughout the distribution process; and the receipt and distribution of each batch is documented. Who is responsible for this requirement, and how is it accomplished?

Testing facility management by addressing these requirements in standard operating procedures (SOPs) Testing facility management is responsible for ensuring that personnel clearly understand the functions they are to perform. At a minimum, the regulations require SOPs approved by management for animal room preparation and for the receipt, identification, storage, handling, mixing, and method of sampling test and control articles. The study protocol provides the specific identification of the test article (for example, by name, lot, or batch number) with instructions regarding how it will be used or prepared for each study.

The Good Laboratory Practice (GLP) regulations require that a protocol be "approved." In this context, what does "approved" mean?

That the sponsor and study director have dated and signed/dated the protocol, respectively The sponsor must have approved the protocol, and the study director must have signed/dated the protocol. The sponsor funds and submits the study report to a regulatory agency, and the study director is responsible for GLP-compliant study conduct. There are generally too many studies underway for management to approve all the methods. The other options do not relate to study approval despite being a normal part of the process.

Subpart K of the U.S. Food and Drug Administration (FDA) regulations describes requirements related to the disqualification of testing facilities. The Environmental Protection Agency (EPA) does not include similar information in its regulations. Where are the EPA's procedures and parameters described?

The EPA's Enforcement Response Policy EPA's Enforcement Response Policy describes the criteria and procedures used by EPA to decide what actions will be taken for regulatory violations.

Quality assurance (QAU) responsibilities are described in the GLP regulations and guidance. Which of the following items is unique to the OECD guidance?

The QAU should verify the study plan contains the information required for compliance and document that verification Per the OECD guidance, the QAU should verify the study plan contains the information required for compliance and document that verification. The QAU should not be involved in the conduct of a study and therefore does not approve protocols.

An animal weighing balance is being moved on a wheeled cart to a work area. Earlier, the same technician had used test weights to verify the equipment's accuracy per a standard operating procedure (SOP). As the weighing operation begins, the technician accidentally bumps the cart on the doorframe, which jars the scale. How could the quality system for this facility be improved?

The SOP should be revised to direct a technician to perform a recheck of the equipment's accuracy any time a scale is moved. The SOP should be revised to direct a technician to perform a recheck of the equipment's accuracy because the SOP did not provide any instruction for this possibility, which is common in busy facilities. Having multiple technicians assigned to critical tasks may be impractical for some facilities due to resources or other reasons. Employees should be trained on the precautions of equipment handling but it is the SOP that should direct how to deal with unforeseen circumstances. If equipment is potentially affected by something such as bumping it into the doorframe, it is always worth taking the time to ensure its accuracy.

All studies at Bes-Tever, Inc. are to be compliant with the U.S. Food and Drug Administration's (FDA) regulations. A particular study protocol designates the test article as "All-Slide3, CAS # 7001-12-3891, Batch # EZ-509." Several different batches of All-Slide3 were received from the sponsor. Where should the personnel handling the test article look to find the batch designated in the protocol?

The container label, which includes the batch identification. The FDA regulations require that all test substance containers be labeled with the batch number, in addition to the substance's name, CAS number or code number, expiration date (if any), and the necessary storage conditions. SDSs also provide the CAS number but do not provide specific batch or lot identifications. In this example, the receiving department's intake log records include the batch/lot numbers, but this information must be on the container labels for verification by subsequent handlers.

An animal care technician is responsible for recording the temperature of each room holding animals twice daily. In one room, there are four studies in progress. How will the studies' final reports reflect the technician's routine work?

The data generated by the technician will demonstrate whether protocol requirements for room environment were achieved. The protocol's animal husbandry portion will have a required temperature/humidity range for the study period. The data generated by the animal care technician will demonstrate whether those requirements were met. If not, a protocol deviation will be necessary to explain the incident and discuss any negative impact on the study.

Both technical and animal care staff are responsible for collecting various types of raw data, which is extremely important to a Good Laboratory Practice (GLP) study. If an error is made while recording any of this data:

The error can be corrected using a GLP-compliant method described more specifically in the facility's SOP. An error made when collecting raw data could occur for a number of reasons. An animal's body weight could mistakenly be entered in the wrong spot on a form, or a scribe might not have heard the speaker clearly. The GLP regulations provide directions to address the need for providing the correct information as soon as possible and in the most efficient manner. Because data entry errors are fairly common and correction is simple, it should not always be necessary to involve the study director. Even when another technician or animal care staff member is needed to give advice or verify the correct entry, the change made to the entry still needs to be done in the standard, GLP-compliant manner.

This module addressed common commercial products used for the cleaning and sanitation of vivarium areas and the materials intended to be used in nonclinical and other studies. Which of the following statements is most accurate regarding the U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) regulations?

The most emphasis is placed on materials that are intended for use in studies The most emphasis is placed on materials intended for use in nonclinical and other studies in the regulations. The receiving agency may use the final reports to make decisions on the quality and integrity of the data generated when determining the effect of a test article on a test system. Commercial products used for cleaning and sanitation are only generally addressed.

Written records associated with the maintenance and calibration of equipment need to include the date of the operation, a verification that the SOP was followed, and a verification that the operation performed followed the routine procedure. What else is required if the operation was not routine (for example, if the equipment was found damaged by the user)?

The nature of the defect, when discovered, and any remedial action taken. Properly operating, precise equipment is critical to the creation of raw data as well as other functions. Therefore, all non-routine operations require documentation of the nature of the defect, when the problem was discovered, and any remedial action taken. An SOP for a hand-held device used to measure the relative humidity of an area might describe how personnel need to assure there is no visible damage and the battery has a full charge before use. This reflects the "routine" procedure that all users must follow. However, if the case of the unit is cracked, non-routine actions are necessary (repairing or replacing the unit).

The quality assurance unit cannot become involved with study conduct. How could a company utilize technical personnel to perform QA functions and still comply with the GLP regulations?

The personnel would be trained in QA responsibilities, but only perform them for projects in which they had no participation. Some facilities train personnel in QA as well as technical responsibilities. They can then perform QA services for projects in which they have no participation. Since the study is not concluded until the study director signs the final report, the action of auditing a report still falls under study conduct. Management cannot issue a directive that is contrary to the regulations.

When Animal and Plant Health Inspection Service (APHIS) inspectors are on-site, they will typically inspect:

The primary enclosures, feed and water containers, and bedding conditions for all animals APHIS inspectors will typically inspect how and where animals are being housed in their primary enclosures, such as cages or pens. These personnel are only concerned with animal care and use areas, but this does not mean that their inspections are casual or brief. It would be unlikely for APHIS to examine "all" vivarium records. However, animal room environmental documentation, the records associated with Institutional Animal Care and Use Committee (IACUC) meetings, and records related to veterinary activities, may be examined. The inspection will be as thorough as necessary to achieve the goals of meaningful and comprehensive monitoring.

Which of the following statements is most correct regarding the goals of a quality system?

The quality system represents management's overall approach to keeping facility operations compliant with the GLP regulations. The quality system represents management's overall approach to keeping facility operations compliant with the GLP regulations. The quality system directs operations before, during, and after study conduct. It is management's responsibility to develop and oversee the quality system. The QAU helps by providing feedback on the effectiveness of the quality system. A quality system should periodically be assessed and revised, as needed, for maximum benefit to the operations of the facility.

Which of the following protocol requirements from the U.S. Food and Drug Administration (FDA) regulations and Environmental Protection Agency (EPA) regulations most directly influences raw data generation and collection?

The records to be maintained The records to be maintained most directly influence raw data generation and collection. Records to be maintained include environmental data in the vivarium or the field plots for agricultural work, records showing the source of the test system, and many other documents necessary for study reconstruction and reporting.

A document used to inform and protect users of commercial products generated by chemical suppliers, including products formulated for sanitization and cleaning of animal housing and vivarium areas, is known as __________.

The safety data sheet (SDS) The SDS comprises one or more pages used to inform users of the product's composition, including inert ingredients, as well as all known and/or anticipated hazards related to its use, storage, handling, and disposal. While much of the information may be repeated on a product label, the SDS is the most complete reference. Typically, SDSs will be retained by the testing facility for reference and documentation of the products used by animal care and technical personnel.

A pesticide manufacturing company has its own small nonclinical laboratory. The company normally conducts and submits its reports as the study sponsor. It prefers to use a contract quality assurance unit (QAU) to fulfill the related regulatory requirements. Several animal rooms are undergoing renovation, so the manufacturing company decides to have a reputable contract nonclinical laboratory with full-time QAU conduct the in-life portion of several high-priority studies. This contract facility will only provide raw data and its study file back to the manufacturing company. Which QAU has the responsibility for study monitoring?

The sponsor's usual contract QAU retains this responsibility and will determine the necessary arrangements between the two facilities. The sponsor's usual QAU might elect to visit the second contract facility in advance of the transfer of the study phase to assess its quality assurance (QA) expertise and capabilities. Specific arrangements will need to be made between the two companies regarding QA monitoring and the documentation of inspections and audits. If there is confidence in the contract facility's QAU, the contract facility's QAU may be able to monitor the in-life portion of the studies.

Regardless of which employee performs a remedial operation (one that corrects conditions caused by an unforeseen circumstance), which staff member is responsible for noting, correcting, and ensuring the actions were documented?

The study director As the study's single point of control, the study director is responsible for ensuring that the actions were noted, corrected, and documented. The principal investigator and department supervisor do not have this oversight responsibility, although they may be given quality control duties to assist the study director. QA officers should never be documenting study-related events. Instead, as part of their inspection and auditing functions, they would report any lapses in standard operating procedures so corrections can be made.

Who is directly responsible for data integrity and determining the accuracy of final reports?

The study director The study director is responsible for data integrity and determining the accuracy of final reports. Management is responsible for providing resources and training and establishing the facility's overall quality system. The EPA and FDA are responsible for determining if the final reports submitted for their approval meet the Good Laboratory Practice requirements and have achieved the protocol's objectives.

For a very small testing facility that conducts a limited number of Good Laboratory Practice (GLP) studies, it is not permissible for which staff member to be responsible for storing and retaining (archiving) specimens and raw data under the conditions described?

The study director, when also authorized as the archivist Management cannot authorize a member of the QAU for the role of archivist because data handling and storage is part of the study conduct. Quality assurance operations must remain separate from the testing facility's normal operations and functions.

A field testing facility has collected crop samples and placed them in a locked freezer commonly used by several researchers. The samples will be shipped to another facility for analysis within two weeks. What is the primary hazard for these specimens?

The thawing of freezer contents The thawing of freezer contents is the primary hazard for these specimens awaiting shipment. A freezer could be accidentally unplugged, be affected by a mechanical failure, or have its door improperly closed. Extra care would be advised when major weather events are predicted. A system for monitoring temperatures daily and using temperature-sensitive alarms are good practices. The chance of mixing up stored materials can be reduced by using complete labels on the samples as they are collected. Not using logbooks is more of a shortfall in recordkeeping than a hazard to the specimens.

Animal vivarium space is often limited, or there may be a greater number of ongoing studies than is typical for a facility. What risk is involved and how can that risk be overcome?

There is a risk that study animals could be confused with those on another study. Each study's animals should be separated using adequate means, such as space and identification. The practice of study separation and unique identification of study animals mitigates the risk. The facility SOP would explain how much space and what kind of identification is required. "Crowded" is a subjective evaluation, and the FDA or APHIS is less likely to make that observation. If airflow is sufficient to control odors, and temperature and humidity in the animal room are acceptable, the number of animals is not relevant. If the study separation is adequate and staff is trained to understand the separation methods, then the risk is mitigated.

Which of the following is correct regarding the definitions of raw data found in the U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) regulations?

They are identical, except the FDA uses the term "nonclinical laboratory study" and the EPA uses the term "study" The FDA and EPA use the same definition of raw data, except the FDA uses the term "nonclinical laboratory study," and the EPA uses the term "study." EPA studies are often conducted in agricultural settings or may be focused on microbes, household insect pests, or soil. The FDA's term "nonclinical" refers to studies that utilize laboratory animals as the test system. This distinguishes them from "clinical" studies that involve human subjects in pharmaceutical and medical device studies. Both agencies recognize the potential for raw data generation by electronic systems.

If the U.S. Food and Drug Administration (FDA) disqualifies a study, will the agency continue to consider other studies submitted by the same nonclinical testing facility?

They may be considered if the submission was prior to the date of disqualification of the substandard study. When a study has been disqualified due to failure to comply with the regulations, the FDA may "exclude from consideration all studies completed after the date of disqualification until the facility can satisfy the Commissioner that it will conduct studies in compliance with such regulations" (21 CFR 58.200) Studies are independent, with their own protocols, but the disqualification may be based on finding that systems in one or more areas of the facility cannot produce regulatory compliance.

What is the primary role of quality assurance (QA)?

To assure management that the facility, records, and controls conform with the Good Laboratory Practice (GLP) requirements. By reporting the GLP compliance status of a study or any facility-related operation to management, the quality assurance unit (QAU) is the primary source of impartial and current information. While all other answers reflect some of the typical roles or responsibilities of QA professionals, they are not the primary role. GLP training for personnel can be provided by various means, and not all QAUs prepare trend reports. Other qualified personnel can interact with clients to address quality concerns or serve as the facility's representative during a regulatory inspection as necessary.

What two things do the GLP regulations require for all personnel "engaged in or supervising" any study?

Training records and a job description Training records and a job description are necessary to fulfill the requirements and guidance set forth by the FDA, EPA, and OECD. These two types of records must be kept current and reflect all aspects of the job to be performed. While ethics, communication skills, and an appreciation for the importance of animal welfare represent desirable and necessary traits, they are not specifically required by the regulations.

Compliance with the Animal Welfare Act and Animal Welfare Regulations is monitored by unannounced, on-site inspections by employees of this government agency:

U.S. Department of Agriculture (USDA) The USDA's Animal and Plant Health Inspection Service (APHIS) carries out these inspections. AALAS is a professional society for education and support of individuals who work in nonclinical laboratories. The NIH has no role in the enforcement of the Animal Welfare Act. The FDA enforces its Good Laboratory Practice (GLP) regulations. Findings related to animal care and use may appear in an FDA inspection report when applicable standard operating procedures (SOPs) are not being followed or unusually poor husbandry or experimental practices are detected.

Animal facility inspections by the Animal and Plant Health Inspection Service (APHIS) are most similar to inspections conducted by the:

U.S. Food and Drug Administration (FDA) It is most common for APHIS inspections to begin with the arrival of an agency investigator at the nonclinical research or supply facility. In the U.S., the FDA often utilizes the same approach when exercising its legal authority to inspect a facility. EPA announces its inspections in writing and provides a target date in advance. A facility's QAU inspections may include animal care findings but are not routinely focused solely on those operations. NIH inspections are to offer accreditation for animal care programs, which is different from a regulatory inspection.

When is the process of applying or assigning unique study identification to laboratory animals necessary?

When the animals are being evaluated and selected for placement into the study group(s) When animals are about to be placed on study, they must be assigned unique identification. Laboratory canines, non-human primates, and most other large animals will already have a unique U.S. Department of Agriculture (USDA) number assigned and tattooed by the supplier. Other identifications may be assigned to such animals to document their participation as test systems. Small animals generally arrive with no identification. However, unique identification must be assigned to small animals.

The services of a pathologist are required for a particular study. After the work is completed and the report has been provided, would it be permitted for the pathologist to archive the materials they evaluated?

Yes, because the regulations permit "multiple locations" if other the regulatory requirements have been fulfilled and there is specific reference to the other locations. The pathologist could archive the materials if the regulatory requirements have been fulfilled. The final report must describe the locations of all specimens. Other archival requirements also must be met.

Bes-Tever, Inc. is a contract testing facility. Management has approved standard operating procedure (SOP) #702, which begins with the following three sections. Do any of the sections need to be updated? TITLE Receipt Of Test Articles SCOPE Any Employee That Is Reasonably Expected To Come Into Contact With Laboratory Chemicals, Reagents, And Test Articles Arriving At The Receiving Department. OVERVIEW OF PROCEDURE To Provide Direction In Accordance With Bes-Tever's Chemical Hygiene Plan For Receiving And Storing All Chemicals, Reagents, And Test Articles Received From Sponsors.

Yes, the title should be updated to include "laboratory chemicals and reagents" to be consistent with the scope and overview. The title section should be updated to be consistent with the other two sections. It is evident that different types of shipments, those intended for general laboratory/vivarium use and those from sponsors, are included in the scope and overview sections. The job descriptions of all Bes-Tever employees may not require any contact with incoming packages, making it unnecessary for management to provide instruction in this SOP.