BTEC 3321

B What type of training should personnel receive in order to remain qualified for their positions? 1. In the particular operations that the employee performs 2. On a continuous basis with sufficient frequency 3. From qualified individuals. 4. All answers are correct 5. In current good manufacturing practice as they relate to the employee's function.

All answers are correct

B In order to remain familiar with cGMP requirements, personnel should be trained in cGMP by qualified individuals... 1. ...on a continuing basis and with sufficient frequency. 2. ...shortly after they are hired. 3. ...before they are hired. 4. ...at their own cost.

...on a continuing basis and with sufficient frequency.

I How long must a company keep reserve samples? 1. 6 months after the expiration date for all drug products 2. 1 year after the expiration date for all drug products 3. 1 year after the expiration date for most drug products, 3 years for drug products that do not require an expiration date 4. 3 years after the expiration date for most drug products, 1 year for drug products that do not require an expiration date

1 year after the expiration date for most drug products, 3 years for drug products that do not require an expiration date

E Identify the correct order of operations when receiving and storing untested components containers, and closures. Packages are received by the receiving warehouse. Packages are shipped to a receiving warehouse. Packages are accepted from the shipper. Packages are visually inspected for appropriate labeling, damage, or any visible signs of contamination. Packages are put into quarantine. Packages are put into quarantine. Packages are stored appropriately, either for use or to be returned. Packages are released from quarantine as either approved or rejected.

1. Packages are put into quarantine. 2. Packages are received by the receiving warehouse. 3.Packages are visually inspected for appropriate labeling, damage, or any visible signs of contamination. 4.Samples of packaged components, containers, or closures are tested. 5.Packages are stored appropriately, either for use or to be returned. 6.Packages are shipped to a receiving warehouse. 7.Packages are accepted from the shipper. 8.Packages are released from quarantine as either approved or rejected.

Subpart C In a cGMP pharmaceutical manufacturing facility, there are many procedures that require separate or defined areas so as to prevent contamination or mixups. Identify the order in which CFR 211 discusses these procedures. 1. Receipt, identification, storage, and quarantine of received materials requiring testing by Quality Control 2. Storage of in-process materials 3. Storage of received material that was released by Quality Control for use 4. Procedures for quality control and laboratory operations 5. Quarantine and storage of drug products requiring quality control testing before release for distribution 6. Areas for aseptic processes 7. Procedures for packaging and labeling operations 8. Procedures for packaging and labeling operations 9. Quarantine and storage of received material, that was rejected by Quality Control, prior to disposition 10 Procedures for manufacturing and processing operations

1. Receipt, identification, storage, and quarantine of received materials requiring testing by Quality ControL 2. Quarantine and storage of received material, that was rejected by Quality Control, prior to disposition 3. Storage of received material that was released by Quality Control for use 4. Storage of in-process materials 5. Procedures for manufacturing and processing operations 6. Procedures for packaging and labeling operations 7. Quarantine and storage of drug products requiring quality control testing before release for distribution 8.Storage of drug products released for distribution 9.Procedures for quality control and laboratory operations 10 Areas for aseptic processes

J All records and log entries must be in chronological order. 1. True 2. False

1. True

F At least ____ person/people is/are required to ensure that the weighing, measuring, or subdividing operations for components is adequately supervised. If the operations are performed by automated equipment, ____ person/people is/are required. 1. 2, 2 2. 2, 1 3. 1,2 4. 1,1

2, 1

J More than one weight system can be used in the same batch in master production and control records. 1. True 2. False

2. False

J Some over the counter drug products are exempted from containing an expiration date because they fulfill the criteria listed under section ________ 1. All drug products must contain an expiration date 2. 211.137 3. 211.115 4. 211.208

211.137

Subpart D The CFR specifically mentions that records should kept documenting the maintenance, cleaning, sanitizing, and inspection activities of all equipment according to the guidelines found in which sections? 1. 211.67 2. 211.68 3. 211.180 4. 211.182

211.180

J Which of the following does not need to be recorded in equipment logs. 1. Scheduled calibration of equipment 2. Regular cleaning 4. Regular lubrication and minor adjustments 5. Annual inspections and maintenance of equipment by certified technicians.

4. Regular lubrication and minor adjustments

J An accurate reproduction of the appropriate master production or control record must be; 1. checked for accuracy 2. dated 3. signed 4. All of the above

All of the above

B A quality control unit shall have the responsibility and authority to [A] or [B] all [C], [D], [E], [F], [G], [H], and [I]. closures reject labeling components in-process materials packaging material approve drug products drug product containers

A. approve B. reject C. components D. drug product containers E. closures F. in-process materials G. packaging material H. labeling I. drug products

B The responsibilities and procedures applicable to the quality control unit shall be in [A]; such written procedures shall be [B]. A>followed B>writing A>writing B>writing A>writing B>followed

A> writing B>followed

Subpart K In order to salvage returned drug products, the quality attributes of the drug product must not have been compromised after being distributed and returned. The condition of the product and packaging material must be confirmed and documented upon receipt of returned drug products. Which of the following material is not specifically listed in the cGMPs in this subsection? 1. Carton 2. Label 3. Container 4. Drug product 5. Active ingredient

Active ingredient

Subpart C What type of lighting is required in pharmaceutical manufacturing facilities? 1. Bright 2. White 3. Adequate 4. Dim

Adequate

J According to the cGMPs, distribution records must contain the following information: (Check all that apply.) 1. Name of product 2. name and address of consignee 3. Strength of product 4. description of dosage form 5. lot or control number 6. date and quantity shipped

All

J The batch production and control records shall include: 1. in-process and laboratory control results 2. All answers apply 3. identity of individual major equipment and lines used 4. statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing

All answers apply

B How many qualified personnel should a company have to perform and supervise the manufacture, processing, packing, or holding of each drug company? 1. As many as the company wants. 2. An adequate number 3.More than is needed 4.twenty

An adequate number

Subpart C In a cGMP pharmaceutical manufacturing facility, what type of buildings should maintain "a clean and sanitary condition", as specifically specified the CFR 211? 1. Any building used in the manufacture, processing, packing, or holding of a drug product. 2. Any building used in the processing, packing, or holding of an drug product. 3. Any building used in the processing, packing, or holding of an ingredient. 4. Any building used in the manufacture, processing, packing, or holding of an ingredient.

Any building used in the manufacture, processing, packing, or holding of a drug product.

Subpart K Drug products that have been subjected to extreme storage conditions as a result of a disaster or accident cannot be salvaged. If there is a question as to whether drug products have been subjected to such conditions, they can only be salvaged if: 1. Records of returned drug products have been well maintained and include the name and label, potency of the drug product, dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug product. 2. Appropriate laboratory tests confirms that the quality attributes of the drug product haven't been compromised and there is evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. 3. Their storage conditions of the drug product after distribution have been well documented. 4. This is an incorrect statement. Drug products can never be salvaged if there is any doubt as to whether they were subjected to these extreme conditions.

Appropriate laboratory tests confirms that the quality attributes of the drug product haven't been compromised and there is evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident.

Subpart C Under what context (procedure) is the CFR211 discussing the following features: floors, walls, ceilings, temperature and humidity controls, air supply, cleaning, equipment maintenance, and other features? 1. Control and laboratory procedures 2. Storage of in-process materials 3. Packaging and labeling operations 4. Aseptic processing

Aseptic processing

E Subpart E lists six requirements for testing and examining samples. Which of the following is not correct? 1. Microscopes should be used to examine components when it is appropriate to do so. 2. At least two tests should be used to verify the identity of the sample. 3. Purity, strength, and quality of each component should be tested against the written specifications provided by the supplier for each characteristic. 4. Any lot that, when tested, that meets the appropriate written specifications of identity, strength, quality, and purity can be approved and released for use. Any lot that does not meet the written specifications must be rejected.

At least two tests should be used to verify the identity of the sample.

B All employees are required to have the necessary education, training, and experience to perform their assigned functions. Companies must maintain documentation of all employees in these matters. They do not have to follow the same strict guidelines for consultants because consultants manage their own documentation. 1. True 2. False

False

E There are six procedures described in Subpart E around collecting samples. Which one of the following is not mentioned in the six procedures? 1. Containers that have been sampled should be marked to show that samples have been taken. 2. Samples should be stored in containers that show the following information: name of material, lot number, date the sample was taken, name of the person who took the sample, identification of the original container from which the sample was taken. 3. Containers should be opened, sampled, and resealed in a manner designed to prevent contamination of the contents and contamination of other components. 4. Containers of each shipment of each lot should be sampled immediately after quarantined.

Containers of each shipment of each lot should be sampled immediately after quarantined.

F If a component is removed from the original container to another, the new container must be identified with the appropriate information. Which of the following answers is not required in the cGMPs. 1. Weight or measure in new container 2. Date component was transfered 3. Receiving or control number 4. Batch identification for which component was dispensed, including its product name, strength, and lot number 5.Component name or item code

Date component was transfered

Subpart C Potable water shall meet the standards prescribed in the __________________Primary Drinking Water Regulations set forth in _____________. 1. Department of Agriculture's, 37 CFR part 148 2. Environmental Protection Agency's, 40 CFR part 150 3. Environmental Protection Agency's, 40 CFR part 141 4. Food and Drug Administration's, 40 CFR part 140

Environmental Protection Agency's, 40 CFR part 141

Subpart G Which of the following statements is NOT a requirement of final drug product inspections as defined in Subpart G. 1. A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling. 2. Results of these examinations shall be recorded in the batch production or control records. 3. Packaging and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. 4. Excess or obsolete labels must be destroyed

Excess or obsolete labels must be destroyed.

B Only management should have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. 1. True 2. False

False

E A representative sample of each shipment of each lot should be collected for testing or examination. Each shipment of each lot for all product types requires the same quantity of samples for testing in order to be statistically representative. 1. False 2. True

False

E Components, containers, and closures approved for use must be rotated so that the oldest stock is used first. Deviations from this requirement are not permitted. 1. True 2. False

False

E Components, containers, and closures should be stored in bags or boxes in an organized manner on the warehouse floors. 1. True 2. False

False

E Components, containers, or closures should be examined visually for appropriate labeling, container damage, broken seals, and contamination while they are in quarantine. 1. True 2. False

False

I Allergenic extracts that are labeled "No U.S. Standard of Potency" are exempt from stability testing requirements. 1. True 2. False

False

I Drug products can still go to market if detected cross contaminated levels of penicillin are below a specified threshold. 1. True 2. False

False

J Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignor, date, and quantity shipped, and lot or control number of the drug product. 1. True 2. False

False

J Records that can be immediately retrieved from another location by computer or other electronic means are NOT subject to reproduction by authorized personnel during inspection. 1. True 2. False

False

Subpart C Sanitation procedures do not apply to work performed by contractors because contractors are not employees of the company. 1. True 2. False

False

Subpart D Computers cannot be used in the manufacture, processing, packing, and holding of a drug product. 1. True 2. False

False

Subpart D cGMPs require that all equipment and utensils be sanitized and/or sterilized between every batch. 1. True 2. False

False

Subpart G Identification must be applied to each individual filled drug product containers that are set aside and held in unlabeled condition for future labeling operations. 1. True 2. False

False

Subpart H Deviations to the FIFO principle is appropriate only if change control is initiated first. 1. True 2. False

False

Subpart H Distribution procedures require the newest batches be shipped off first. 1. True 2. False

False

Subpart H Drug product attributes can never be affected by temperature. 1. True 2. False

False

Subpart H Packaged drug products must be quarantined until they are approved for distribution by quality assurance. 1. True 2. False

False

Subpart J The master production and control records can be signed electronically. 1. True 2. False

False

Subpart K Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures can only be salvaged and returned to the marketplace if appropriate testing and documentation confirms that the quality attributes of the drug product have not been compromised. 1. True 2. False

False

K In order to salvage returned drug products, the quality attributes of the drug product must not have been compromised after being distributed and returned. The condition of the product after being subjected to various stresses must be confirmed and documented upon receipt of returned drug products. Which of the following stresses is not specifically listed in the cGMPs in this subsection? 1. How the drug products were packaged 2. How the drug products were stored 3. How the drug products were held 4. How the drug products were shipped

How the drug products were packaged

Subpart C How often should trash and organic waste matter be disposed of? 1. In a timely manner 2. Once a month 3. As often as needed 4. Once a week

In a timely manner

Subpart D Identify all of the procedures specifically mentioned in the CFR that relates to equipment cleaning and maintenance. 1.Inspection of equipment for cleanliness immediately before use 2. Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules 3. Protection of clean equipment from contamination prior to use 4. A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance 5. Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in 211.180 and 211.182 6.Removal or obliteration of previous batch identification 7.Assignment of responsibility for cleaning and maintaining equipment 8. Managing the operation of the equipment and designed

Inspection of equipment for cleanliness immediately before use Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules Protection of clean equipment from contamination prior to use A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance Removal or obliteration of previous batch identification Assignment of responsibility for cleaning and maintaining equipment

Subpart G _________ permit determination of the history of the manufacture and control of the batch. 1. Expiration dates 2. batch codes 3. Lot or control numbers 4. Product barcodes

Lot or control numbers

Subpart G ________ shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected. 1. Individual rooms 2. Records 3. Separate buildings 4. Air filters

Records

Subpart K Records of returned drug products must be maintained and contain the appropriate information. Which of the following is not specifically listed in the cGMPs in this subsection: 1. Reason for return 2. ultimate disposition of the returned drug product 3. Date of distribution 4. Drug name 5. Amount or number of drug product returned 6. Dosage form of in-process material 7. Lot, batch, or control number

Lot, batch, or control number

F It is required to have written procedures that establish and describe in-process controls, tests, and examinations of samples during manufacturing processing. Why is it required to sample and test in-process materials and drug products? 1. Monitor output. 2. Waste employee time. 3. Validate the performance of manufacturing processes, especially those susceptible to causing variability in the characteristics of the intermediate and final drug products. 4. Assure batch uniformity and integrity.

Monitor output. Validate the performance of manufacturing processes, especially those susceptible to causing variability in the characteristics of the intermediate and final drug products. Assure batch uniformity and integrity.

Subpart G A representative sample of units shall be collected _________________ and shall be visually examined for correct labeling. 1. Only after they have been approved for use because they meet predefined specifications. 2. Only after they have been rejected for use and marked for destruction. 3. Only after they have been stored in quarantine for one month. 4. Only after they have been received and identified.

Only after they have been approved for use because they meet predefined specifications.

Subpart G Are gang-printed labels allowed for drug product labeling? 1. Gang-printed labeling is prohibited. 2. Only if the labeling from gang-printed sheets is adequately differentiated by size, shape, or color. 3. Only if the labeling from gang-printed sheets is the same in size, shape, and color. 4. Gang-printed labeling is an appropriate method for printing labels.

Only if the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.

F When is it appropriate to reprocess a batch or an intermediary batch? 1. Only with the approval of the quality control unit. 2. Only if the reprocessed batches or intermediary batches will conform to the predefined standards or specifications. 3. When batches or intermediary batches do not conform to the predefined standards or specifications. 4. Only if reprocessing the batch will save the company money.

Only with the approval of the quality control unit. Only if the reprocessed batches or intermediary batches will conform to the predefined standards or specifications. When batches or intermediary batches do not conform to the predefined standards or specifications.

Subpart K In order to salvage returned drug products, the quality attributes of the drug product must not have been compromised after being distributed and returned. All of the below are acceptable tools or techniques to ensure the quality of the returned drug product is still intact. Which of the following is least important, and should not be solely relied upon? 1. Documentation of storage and shipping conditions after the drug product was distributed 2. Organoleptic examinations of the drug product 3. Examination, testing, and documentation of the packaging material 4. Analytical testing of the drug product

Organoleptic examinations of the drug product

E Which of the following statements is most correct? 1. Quarantined components, containers, and closures, once approved for use, are to be stored in such a manner that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. 2. Quarantined components, containers, and closures, if rejected for use, are to be stored in such a manner that the oldest stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. 3. Quarantined components, containers, and closures, once approved for use, are to be stored in such a manner that the oldest approved stock is used first. Deviation from this requirement is permitted as needed. 4. Quarantined components, containers, and closures, once approved for use, are to be stored in such a manner that the oldest approved stock is used first. Deviation from this requirement is never permitted.

Quarantined components, containers, and closures, once approved for use, are to be stored in such a manner that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.

F Why must all major equipment be identified by a distinctive identification number or name? 1. So as to be able to keep track of the age of equipment. 2. So as to be able to record and show the specific equipment used in the manufacture of each batch of drug product. 3. So as to be able to communicate proper use of equipment. 4. So as to create fun names for each piece of equipment.

So as to be able to record and show the specific equipment used in the manufacture of each batch of drug product.

I Which of the following statements is true about testing batches of drug products? 1. Conformance means that the final drug products in each batch closely resembles each other. 2. Randomly selected batches of drug products need to be tested for conformance. 3. Testing must include the identity and strength of the active ingredient. 4. Batches of drug products must be tested after release.

Testing must include the identity and strength of the active ingredient.

I A written testing program is required to test the stability of drug products. The program must include all of the following. Which one is not accurate? 1. Testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted 2. Storage conditions for samples retained for testing 3. Reliable, meaningful, and specific test methods 4. Testing of the drug product in a different container-closure system as that in which the drug product is marketed 5.Sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability

Testing of the drug product in a different container-closure system as that in which the drug product is marketed

Subpart K If the reason for a drug product being returned implicates associated batches what should be done? 1. associated batches must be distributed as soon as possible 2. an appropriate investigation should be conducted 3. The company must conduct an external audit using third party investigators 4. associated batches must be properly destroyed

The company must conduct an external audit using third party investigators

B How does a company prove that a hired consultant has the education, training, and experience required to advise on the subject for which they are retained? 1. The company should hire the people they know. 2. The company should choose the most expensive consultants. 3. The company should rely on a consultant's resume. 4. The company should maintain records stating the qualifications of any consultant used.

The company should maintain records stating the qualifications of any consultant used.

I What should be done if there is a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin? 1. The drug product must be centrifuged to separate any penicillin from it. 2. The drug product must be treated with a thorough penicillin chemical extraction. 3. The drug product must be immediately properly disposed of. 4. The non-penicillin drug product shall be tested for the presence of penicillin.

The non-penicillin drug product shall be tested for the presence of penicillin.

F It is required that during the production of a batch of drug products, all containers, processing lines, and major equipment contain identification information at all times. What information is being identified? (More than one answer.) 1. To indicate a unique identifier for each piece of equipment. 2. To indicate their current contents. 3. When necessary, to indicate the phase of processing of the batch. 4. To identify the conditions of the equipment.

To indicate their current contents. When necessary, to indicate the phase of processing of the batch.

Subpart C What is required before rodenticides, insecticides, and fungicides (as well as fumigating agents, and cleaning and sanitizing agents) can be used? Check all the statements that are true. 1. Must only be used in small quantities. 2. Must be registered and used in accordance with the Federal 3. Insecticide, Fungicide, and Rodenticide Act. 4. Written procedures must be designed so as to prevent 5. contamination. 6. Cannot be used on people. 7. Can only be used by management. 8.There must be written procedures for their use. 9.Written procedures must be followed. 10.They must be in approved containers.

There must be written procedures for their use. Written procedures must be followed. Must be registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act. Written procedures must be designed so as to prevent contamination.

Subpart G What is the appropriate course of action for excess unused labels that bear lot or control numbers? 1. They should be quarantined. 2. They should be recycled. 3. They should be stored away for use at another time. 4. They should be destroyed.

They should be destroyed.

Subpart G What is the appropriate course of action for obsolete and outdated labels? 1. They should be destroyed. 2. They should be recycled. 3. They should be sold to another manufacturer who can use them. 4. They should be quarantined.

They should be destroyed.

Subpart K How should returned drugs be identified immediately upon receipt? 1. They should be marked for destruction. 2. They should be marked as excess material and held. 3. They should be marked as restock and held. 4. They should be marked as returned drugs and held.

They should be marked as returned drugs and held.

E Drug product containers and closures must meet certain requirements. What requirements are specifically mentions in the cGMPs? (Multiple answers.) 1. They must be clear and see-through. 2. They should provide adequate protection against foreseeable external factors. 3. They should be clean and, where necessary, sterile. 4. They cannot be reactive, additive, or absorptive so as to alter the drug product.

They should provide adequate protection against foreseeable external factors. They cannot be reactive, additive, or absorptive so as to alter the drug product. They should be clean and, where necessary, sterile.

B Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. 1. True 2. False

True

B Good sanitation and health habits are essential responsibilities of employees. 1. True 2. False

True

B The quality control unit has the responsibility to approve or reject all procedures that affect any characteristic [identity, strength, quality, and purity] of a drug product. 1. True 2. False

True

E Components, containers, or closures should be examined visually for appropriate labeling, container damage, broken seals, and contamination before they are quarantined. 1. True 2. False

True

E Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. 1. True 2. False

True

F Specifications for in-process material should be consistent with the specifications of the final drug product. 1. True 2. False

True

F Time limits for the completion of a process can be used as a quality control tool to assure the quality of a drug product. 1. True 2. False

True

I Each batch of drug product must be free of objectionable microorganisms, and tested accordingly. 1. True 2. False

True

Subpart D Automatic, mechanical, or other electronic equipment can be used if they are routinely calibrated and inspected. Calibration checks and inspections must be documented and stored in written records. 1. True 2. False

True

Subpart G Homeopathic drug products do not require expiration dating. 1. True 2. False

True

Subpart G Some exceptions aside, an OTC drug product that is not packaged in a tamper-resistant package is considered adulterated regardless of whether the package has been opened or not. 1. True 2. False

True

Subpart H A recall program must have a distribution system that can easily track the destination of each shipment by lot. 1. True 2. False

True

Subpart H Drug product attributes can sometimes be affected by humidity. 1. True 2.False

True

Subpart H Drug product attributes can sometimes be affected by light. 1. True 2. False

True

Subpart H Packaged drug products must be quarantined until they are approved for distribution by quality control. 1. True 2. False

True

Subpart K All procedures for holding, testing, and reprocessing of returned drug products must be in writing and they must be followed. 1. True 2. False

True

Subpart K Returned drugs can be returned to market if appropriate protocols are followed. 1. True 2. False

True

Subpart K Using your sense organs to examine returned drug products to determine whether the drug products still meet appropriate quality standards is acceptable, but only as supplemental evidence. 1. True 2. False

True

Subpart G Written procedures for packaging and labeling operations should incorporate specific features. These procedures are to assure that correct labels, labeling, and packaging materials are used for drug products. Identify all features listed in Subpart G. 1. Use of lot or control numbers so as to track the manufacturing history of drug products. 2. Examine packaging and labeling material for suitability and correctness before packaging operations, and to document such examinations. 3. To physically or spatially separate the labeling operations of different drug products to prevent mixups and cross-contamination. 4. Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. 5. Ensure that all labeling operations of different drug products are being performed in the same spatial area. 6. Ensure that unlabeled containers that are filled drug products are being appropriately identified and handled while they await future labeling operations. 7. Ensure that containers are labeled first before they are filled with drug products. 8. Use of the same lot or control number for all manufacturing batches.

Use of lot or control numbers so as to track the manufacturing history of drug products. Examine packaging and labeling material for suitability and correctness before packaging operations, and to document such examinations. To physically or spatially separate the labeling operations of different drug products to prevent mixups and cross-contamination. Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Ensure that unlabeled containers that are filled drug products are being appropriately identified and handled while they await future labeling operations.

B When can a person who is ill or have open lesions be allowed to have contact with components, drug product containers, closures, in-process materials, and drug products? 1. When the condition is corrected. 2. When it has been determined by a competent medical personnel that the condition does not jeopardize the safety or quality of drug products. 3. When the employee feels better. 4. When either the 1st or 2nd option occurs

When either the 1st or 2nd option occurs.

F When must written procedures, designed to prevent microbiological contamination, include validation of all aseptic and sterilization processes. 1. When the drug product in not required to be sterile. 2. When the manufacturing employees are particularly dirty. 3. When the drug product is purported to be sterile. 4. When the manufacturing facilities are particularly dirty.

When the drug product is purported to be sterile.

I Which of the following statements is not true with regards to written procedures about sampling and testing plans. 1. Written procedures must include the number of units per batch to be tested. 2. Written procedures must be memorized. 3. Written procedures must include method of sampling. 4. Written procedures must be followed.

Written procedures must be memorized.

Subpart H __________ procedures describing the warehousing of drug products shall be established and __________. 1. Established, adhered to 2. Written, followed 3. cGMP, trained on 4.FDA, obeyed

Written, followed

Subpart H Written procedures describing warehouse operating procedures for distributing drug products must include (multiple answers): 1. a quarantine system 2. appropriate temperature, humidity, and light storage conditions 3.a recall program in the event a recall is required 4. a procedure for ensuring that the oldest approved stocks are distributed first

a procedure for ensuring that the oldest approved stocks are distributed first a recall program in the event a recall is required

I Special testing is required for all of the following types of drugs except: 1. drug products with controlled-release dosages 2. sterile drug products 3. antibiotics 4. ophthalmic ointments

antibiotics

Subpart D Input to and output from the computer or related system of formulas or other records or data shall be checked for _______. 1. accuracy 2. errors 3. consistency 4. precision

accuracy

E When would it be appropriate to retest components, containers, and closures even though they have been released for use. (Multiple answers.) 1. after storage for long periods 2. after exposure to heat 3. at the end of a shift 4. after exposure to air

after storage for long periods after exposure to heat after exposure to air

Subpart D Equipment must be made of material that will not __________ the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 1. ruin 2. disrupt 3. destroy 4. alter

alter

Subpart G Any two-piece, hard gelatin capsule covered by this section must be sealed using _____________ 1. non-gluten based sealant due to possible allergens. 2. an acceptable tamper-evident technology. 3. safe to consume adhesives. 4. recyclable materials as per EPA guidelines.

an acceptable tamper-evident technology.

Subpart D Equipment and utensils shall be cleaned, maintained, and, as__________________, sanitized and/or sterilized at ________________ to prevent malfunctions or contamination. 1. appropriate for the schedule of the personnel, appropriate intervals 2. appropriate for the schedule of the personnel, scheduled times 3. appropriate for the nature of the drug, scheduled times 4. appropriate for the nature of the drug, appropriate intervals

appropriate for the nature of the drug, appropriate intervals

E Upon receipt and before acceptance, what should each container or grouping of containers of components, drug product containers, and closures be examined visually for? (Select ALL THAT APPLY.) 1. flammable/corrosive material warning signs 2. authorize personnel signature 3. appropriate labeling as to contents 4. expiration dates 5. container damage 6. contamination 7. broken seals 8. country of manufacture and origin

appropriate labeling as to contents container damage contamination broken seals

F Written procedures, including any changes, shall be drafted, reviewed, and approved by the _____________ and reviewed and approved by __________. 1. facility general manager, the internal audit team 2. appropriate organizational units, the quality control unit 3. manufacturing department head, the quality assurance unit 4. quality assurance unit, the quality control unit

appropriate organizational units, the quality control unit

I Stability testing procedures is used to determine what? Select all that apply. 1. instructions for how to administer the drug 2. appropriate storage conditions 3. expiration dates 4. dosage for each age group

appropriate storage conditions expiration dates

Subpart H Written procedures that describe warehouse operating procedures for storing drug products must include (multiple answers): 1. appropriate temperature, humidity, and light storage conditions 2. a quarantine system 3. a recall program in the event a recall is required 4. a procedure for ensuring that the oldest approved stocks are distributed first

appropriate temperature, humidity, and light storage conditions a quarantine system

F What is required when reprocessing batches that do not conform to established standards or specifications? 1. written procedures prescribing a system for reprocessing batches 2. Reprocessing of non-conforming product is never allowed. No requirements needed as non-conforming products are safely disposed of to protect consumer safety. 3. review of quality assurance unit 4. approval of quality assurance unit 5. approval of quality control unit 6. review of quality control unit 7. product conformation with all established standards, specifications, and characteristics 8. complete sterilization of processing area and surrounding areas

approval of quality control unit review of quality control unit product conformation with all established standards, specifications, and characteristics written procedures prescribing a system for reprocessing batches

I Animals used in testing components, in-process materials, or drug products for compliance with established specifications shall be maintained and controlled in a manner that _________________. 1. complies with animal rights group demands 2. assures personnel is protected against bites and/or scratches 3. assures their suitability for their intended use 4. complies with recommendations set forth by a licensed veterinarian

assures their suitability for their intended use

I How much reserve sample must a company keep for each batch of drug product released to the market? 1. at least twice the quantity necessary for all tests required 2. reserve samples are not required. 3. at least three times the quantity necessary for all tests required 4. enough quantity to perform all tests required

at least twice the quantity necessary for all tests required

J Written records concerning the need for changes in drug product specifications, manufacturing, or control procedures shall be maintained so that data therein can be used for evaluation ____________ . 1. at least once every two years 2. once every other month 3. at once a year 4. once a month

at once a year

Subpart G When can labeling and packaging materials be released for use? 1. when an error in the labeling process occurs 2. before the start of the labeling processing 3. at each step of the manufacturing process 4. at the completion of finishing operations

at the completion of finishing operations

F Which of the below statements best describes how often yields and percentages of theoretical yields should be determined in the manufacturing process? 1. at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of a drug product 2. at the beginning of each process during manufacturing, processing, packaging, or holding of a drug product 3. Whenever an operator is concerned about the process. 4. at the conclusion of drug production for each batch produced.

at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of a drug product

F When executing written production and process control procedures, documentation must occur ___________. 1. when all hazardous materials are cleared from the processing area 2. after all applicable validation tests are conducted 3. at the time of performance 4. as described by the quality control personnel present

at the time of performance

Subpart C There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the ___________, __________, __________, and ___________ to be used in cleaning the buildings and facilities; such written procedures shall be followed. 1. cleaning schedules, methods, equipment, and materials 2. cleaning schedules, date, equipment, and personnel 3. cleaning schedules, methods, equipment, and location 4. personnel, methods, equipment, and materials

cleaning schedules, methods, equipment, and materials

E Procedures are to be written and followed that sufficiently detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of what material? (There may be more than one answer.) 1. batches 2. intermediates 3. drug products 4. quality control tests 5. labels 6. containers 7. closures

closures components components

Subpart D The degree and frequency of input/output verification shall be based on the ______________ of the computer or related system. 1. complexity and accuracy 2. complexity and precision 3. precision and accuracy 4. complexity and reliability

complexity and reliability

J Labels and labeling examinations and reviews are documented for _______________ . 1. correct lot numbers 2. correct product names 3. conformity with established specifications 4. appropriate personnel signatures

conformity with established specifications

E Components, containers, and closures should be handled and stored to prevent what? 1. contamination 2. loss 3. mixup 4. quarantine

contamination

Subpart C The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent ____________. 1. inconsistent labeling 2. contamination 3. personnel injury 4. the labeling from becoming illegible 5. improper facility layout

contamination

Subpart C Potable water shall be supplied under ____________________ in a plumbing system free of defects that could contribute contamination to any drug product. 1. continuous negative pressure 2. continuous positive pressure 3. constant negative pressure 4. constant positive pressure

continuous positive pressure

Subpart D Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate [x], adequate [y], and suitably [z] to facilitate operations for its intended use and for its cleaning and maintenance. 1. color 2. sterile 3. operations 4. design 5. material 6. function 7. size 8. located 9. facilities 10. clean

design, size, located

I Procedures shall require appropriate retesting of any component, drug product container, or closure that is subject to ____________. 1. deterioration 2. contamination 3. UV damage 4. mislabeling

deterioration

Subpart H A system by which the _________ of each lot of drug product can be readily determined to facilitate its recall if necessary. 1. expiration date 2. active ingredient 3. distribution 4. original manufacturing site

distribution

B In a cGMP lab, protective apparel is primarily worn to protect what from contamination?: 1. environment 2. drug products 3. employees 4. personnel

drug products

I Besides meeting appropriate specifications, what else is specifically required as part of the acceptance/rejection criteria when sampling and testing drug products as a condition of their approval and release. 1. appropriate quantity numbers for analysis 2. drug products must meet appropriate statistical quality control criteria 3. inspection of documentation by a quality control technician 4. review of all training documents

drug products must meet appropriate statistical quality control criteria

Subpart D The use of an asbestos-containing filter is ________. 1. must be approved by authorized personnel 2. prohibited 3. not preferred, but allowed when no other filter is available 4. common practice

prohibited

B All personnel engaged in the manufacture, processing, packing, or holding of a drug product must have the __________, __________, and __________ to enable personnel to perform their assigned duties. (Select all that apply.) 1. skills 2. education 3. understanding 4. training 5. instructions 6. knowledge 7. mentor 8. experience

education training experience

B A quality control unit shall be responsible for approving or rejecting drug products that are: (select all that apply) 1. packed 2. processed 3. manufactured 4. packaging material 5. held under contract by another company 6.drug product containers 7. closures 8. components

processed manufactured held under contract by another company packed

Subpart C According to the design and construction guidelines, any building used in the manufacture, processing, packing, or holding of a drug product should: (Select all that apply according to cGMP guildines.) 1. have adequate space for the orderly placement of equipment and materials to prevent mixups. 2. be new with state of the art equipment. 3. be of suitable size, construction, and location to allow for proper cleaning, maintenance, and operations of the buildings. 4. meet budget requirements of the company so as to ensure the company can pay their employees.

have adequate space for the orderly placement of equipment and materials to prevent mixups. be of suitable size, construction, and location to allow for proper cleaning, maintenance, and operations of the buildings.

Subpart C An air supply is filtered through _____________ filters under _____________, regardless of whether flow is laminar or nonlaminar. 1. low-efficiency particulate air, positive pressure 2. high-efficiency particulate air, no pressure 3. high-efficiency particulate air, positive pressure 4. low-efficiency particulate air, positive pressure

high-efficiency particulate air, positive pressure

Subpart C What is considered adequate washing facilities as specifically stated in the cGMPs? (There are multiple answers.) 1. air driers and single-service towels 2. soap or detergent 3. air driers or cloth towels 4. hot or cold water 5. soap and detergent 6. hot and cold water 7. clean toilet facilities easily accessible 8. air driers or single-service towels

hot and cold water clean toilet facilities easily accessible air driers or single-service towels soap or detergent

Subpart G Labeling materials issued for a batch shall be carefully examined for _____________ 1. directions for the processing of the batch. 2. identity and conformity to the labeling specified in the master or batch production records. 3. management approval. 4. adverse reactions that may affect consumers.

identity and conformity to the labeling specified in the master or batch production records.

F There shall be written procedures for production and process control designed to assure that the drug products have the ______________ they ___________ to possess. 1. identity, strength, and quality / are prescribed 2. identity, strength, quality, and purity / purport or are represented 3. identity, strength, quality, and purity / are manufactured 4.safety and efficacy / purport or are represented

identity, strength, quality, and purity / purport or are represented

Subpart C What type of animals are allowed in a pharmaceutical manufacturing plant? 1. laboratory animals 2. insects 3. No animals are allowed 4. birds 5. rodents

laboratory animals

Subpart G Access to the storage area shall be ____________ 1. limited to authorized personnel. 2. openly available for all manufacturing personnel. 3. safely unobstructed by containers. 4. completely sealed off to prevent contamination.

limited to authorized personnel.

J If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that __________ 1. the product is adequately time stamped on its label. 2. lots or batches of such product follow in numerical order and are manufactured in numerical sequence. 3.the product lots distribution is able to be efficiently tracked. 4. Individual equipment logs are ALWAYS required.

lots or batches of such product follow in numerical order and are manufactured in numerical sequence.

Subpart C Any building used in the __________, __________, __________, or __________ of a drug product shall be maintained in a good state of repair. (More than one answer applies.) 1. manufacture 2. management 3. offices 4. processing 5. building 6. holding 7. programming 8. packing

manufacture processing holding packing

Subpart C Drug manufacturing facilities can include many types of buildings. Within such facilities, only buildings used in the ___________, ____________, ____________, or __________ are required to meet all design and construction guidelines found in CFR211 Subpart C. 1. offices 2. management 3. manufacture 4. programming 5. sales 6 processing 7. holding 8. packing

manufacture processing holding packing

Subpart D Appropriate controls shall be exercised over computer or related systems to assure that changes in_________ or other records are instituted only by authorized personnel. 1. master production and control records 2. batch records and control records 3. master production 4. control records 5. master production and batch records 6. batch records

master production and control records

I During reprocessing, reprocessed material must _____________ . 1. be held indoors 2. be held in holding for at least two weeks. 3. meet appropriate standards 4. be UV light resistant 5. be adequately distributed with materials processed only once 6. meet specifications

meet specifications meet appropriate standards

Subpart D Written procedures will include a description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the ________________ as necessary to assure proper cleaning and maintenance. 1. methods of disassembling and reassembling equipment 2.methods of repair for equipment 3. specifications of machinery and equipment 4. chemical composition of cleaning solvents

methods of disassembling and reassembling equipment

E A representative sample of each shipment of each lot should be collected for testing or examination. Identify the statistical criteria mentioned in subpart E that should be used to determine how much of a representative sample is appropriate for testing. (There is more than one answer.) 1. minimum product quantity needed for analysis 2. level of confidence required 3. minimum quantity needed for reserve where required by section 211.170. 4. 0.05% of the lot 5. ten percent of the lot 7. past history of the supplier's product quality 8. component variability level 9. degree of precision desired

minimum quantity needed for reserve where required by section 211.170. level of confidence required minimum product quantity needed for analysis component variability level degree of precision desired past history of the supplier's product quality component variability level degree of precision desired

Subpart D What type of filters are most preferred (unless otherwise stated) for liquid filtration according to the cGMPs? (More than one answer.) 1. liquid filtration 2. nonfiber-releasing 3. human use only 4. asbestos-containing 5. pore size rating of 0.2 microns 6. pore size rating of 0.45 microns 7. fiber-releasing 8. cannot contain asbestos

nonfiber-releasing pore size rating of 0.2 microns cannot contain asbestos

I Instruments, apparatus, gauges, and recording devices not meeting established specifications shall __________. 1. not be recalibrated 2. be properly disposed of 3. be aseptically cleaned 4. not be used

not be used

F Written production and control procedures must include formulation instruction that ensures that each batch receives __________ of the labeled or established amount of active ingredient. 1. greater than 95% 2. not less than 100% 3. greater than 99% 4. not less than 99%

not less than 100%

Subpart H According to proper distribution procedures the _______ of a drug product is distributed first. 1. most recently examined 2. most recently approved 3. most conforming lot according to master batch records 4.oldest approved stock

oldest approved stock

J Other than the initial person who performs each test, how many person(s) need(s) to initial or sign the laboratory records showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. 1. two 2. none 3. three 4. one

one

Subpart J Written record of each complaint needs to be maintained for at least: (Check all that apply) 1. two years after the expiration date of drug product 2. one year after the date that the complaint was received 3. one year after the expiration date of the drug product 4. seven years after the date that the complaint was received 5. three years after distribution of the drug products when there is lack of expiration date under the exemption of 211.137

one year after the date that the complaint was received one year after the expiration date of the drug product three years after distribution of the drug products when there is lack of expiration date under the exemption of 211.137

B Personnel are authorized to enter limited-access areas... 1. only if authorized by supervisory personnel 2. at all times 3. only at designated times 4. only if they are supervisors

only if authorized by supervisory personnel

Subpart C Operations relating to the manufacture, processing, and packing of ___________ shall be performed in facilities separate from those used for other drug products for human use. 1. vitamins 2. acetaminophen 3. closures and containers for antibotics 4. Penicillin 5.proteins

penicillin

E How are each lots of components, containers, and closures shipped to the receiving warehouse identified before use? (Select all that apply.) 1. quarantined 2. cleared 3. rejected 4. approved

quarantined rejected approved

Subpart D Equipment must be constructed of material that is not __________, __________, or __________. 1. marble, stainless steel, or concrete 2. absorptive, reactive, or shiny 3. reactive, additive, or absorptive 4.reactive, stainless steel, or concrete

reactive, additive, or absorptive

Subpart C If air is recirculated to production areas, measures shall be taken to control __________ of dust from production. 1. iltration 2. vaccuming 3. collection 4. recirculation 5. suction

recirculation

Subpart G Any labeling or packaging materials that do not meet appropriate specifications shall be: 1. approved for the sake of saving costly materials. 2. rejected to prevent their use in operations for which they are unsuitable. 3. rejected to prevent the final product from being visually unattractive. 4. saved for reuse.

rejected to prevent their use in operations for which they are unsuitable.

Subpart D Equipment cleaning and maintenance procedures shall include the_____________ of previous batch identification. 1. removal or obliteration 2. storage and labeling 3. recording and processing 4. care and maintainance

removal or obliteration

Subpart D Automatic, mechanical, or electronic equipment or other types of equipment, including computers, shall be _______ calibrated, inspected, or checked according __________________ to assure proper performance. 1. rarely, to an algorithm designed 2. routinely, to an algorithm designed 3. rarely, to a written program designed 4.routinely, to a written program designed

routinely, to a written program designed

Subpart C Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a __________ and __________ manner. 1. proper 2. clean 3.written 4.temporary 5. sanitary 6. followed 7. safe 8. easy

sanitary safe

Subpart D The safety, identity, strength, quality, or purity of the drug product _____________ beyond the _____________________. 1. shall not be altered, official or other established requirements 2.kept within acceptable range, official or other established requirements 3.shall not be altered, the necessities of the drug product 4.kept within acceptable range, the necessities of the drug product

shall not be altered, official or other established requirements

Subpart D Any substances required for operation, such as lubricants or coolants, ___________ with components, drug product containers, closures, in-process materials, or drug products. 1.shall not come into contact 2.shall be thoroughly mixed 3.shall be within close and manageable proximity 4.shall be sorted according to production order

shall not come into contact

Subpart K A drug product may be reprocessed provided the subsequent drug product meets _____________. 1. specifications 2. appropriate standards 3. characteristics 4. patient demand 5. production schedule 6.distribution network requirements

specifications appropriate standards characteristics

Subpart H Drug products must be stored under appropriate conditions. Which is not a condition mentioned in the cGMPs. 1. sterility 2. temperature 3. humidity 4. light

sterility

Subpart H Storage of drug products must occur under appropriate conditions so that the _____________ of the drug products are not affected. 1. containers/packaging 2. strength 3. purity 4. stability 5. identity 6. quality

strength purity identity quality

F Operations of weighing, measuring, subdividing, or charge-in must be verified by a second person, unless: 1. Quality Control authorizes a deviation. 2. the operations are performed by automated equipment. 3. the operations are properly documented in production batch records. 4. the operator is sufficiently experienced through training.

the operations are performed by automated equipment.

F Any deviation made concerning the established time limits set forth set from process procedures may be acceptable if ____________. 1. such deviation does not compromise the quality of the drug product 2. Deviation from the established time limits are never acceptable. The entire batch must be correctly disposed of to ensure consumer safety. 3. such deviation is approved by at least a single member of the quality assurance team. 4. such deviation is adequately documented 5. such deviation is adequately justified 6. such deviation is approved by at least a single member of the quality control team.

such deviation does not compromise the quality of the drug product

Subpart H Deviation from the FIFO requirement is permitted if ________________ . 1. such deviation is permanently changed by the quality assurance unit 2. Deviations from the FIFO requirement are never permitted 3.such deviation is temporary 4. such deviation is temporary and appropriate

such deviation is temporary and appropriate

E Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if ________. 1. such deviation is temporary and appropriate. 2. current storage conditions are not able to fit all on hand stock inventory. 3. the quality control unit makes it an official and permanent part of standard operating protocol. 4. No deviation from this regulation is allowed.

such deviation is temporary and appropriate.

B A quality control unit should have adequate laboratory facilities to _________________ components, drug product containers, closures, packaging materials, in-process materials, and drug products. 1. test 2. test, approve, reject 3. reject 4. approve

test, approve, reject

Subpart G Inspection shall be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in __________ 1. the batch production records. 2. Quality unit's audit records. 3. the standard operating protocol's notes section. 4. the daily logbook.

the batch production records.

F Deviations of written production and process control procedures are only allowed if: 1. the deviations are approved by Quality Control. 2. the deviations are recorded and justified. 3. the deviations are minor. 4. This is a false statement. Deviations are never allowed.

the deviations are recorded and justified.

Subpart J Where an investigation under 211.192 is conducted, the written record shall include __________ . 1. the findings of the investigation and followup 2. the findings of the investigation and calculations pertaining to out of specification measurements 3. correct references to the master records and calculations pertaining to out of specification measurements 4. personnel statements made during the investigation and followup

the findings of the investigation and followup

I For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding __________________. 1. the presence of foreign particles and harsh or abrasive substances 2. the ointment's water solubility 3. the fluidity of the ointment 4. the ointment's melting point

the presence of foreign particles and harsh or abrasive substances

I For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for __________. 1. the rate of release of each active ingredient 2. pill size 3. the product container 4. all the above

the rate of release of each active ingredient

Subpart J Where an investigation under 211.192 is not conducted, the written record shall include _____________ and the ____________. 1. the reason that an investigation was found not to be necessary, name of the responsible person making such a determination 2. the reason that an investigation was found not to be necessary, time and date of the occurrence. 3. an adequate action done in place of the investigation, name of the responsible person making such a determination. 4. an adequate action done in place of the investigation, time and date of the occurrence.

the reason that an investigation was found not to be necessary, name of the responsible person making such a determination

J Which of the following is not required to be included in the "component, drug prdouct container, closure, and labeling records". 1. name of supplier 2. the shipping carrier information 3. supplier's lot number 4. identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling

the shipping carrier information

F For weighing, measuring, or subdividing operations, a second person must ensure that (select all that apply): 1. the weight or measure is correct as stated in the batch production records 2. the component was released by the quality control unit 3. the operator is well rested 4. the containers are properly identified

the weight or measure is correct as stated in the batch production records the component was released by the quality control unit the containers are properly identified

Subpart D Substances required for equipment operation can only be used if: (more than one answer) 1. they do not come into contact with components, drug product containers, closures, in-process materials, or drug products 2. they alter the safety, identity, strength, quality, or purity of the drug product 3. they come into contact with components, drug product containers, closures, in-process materials, or drug products 4. they come into contact with components, drug product containers, closures, in-process materials, or drug products

they do not come into contact with components, drug product containers, closures, in-process materials, or drug products

J A percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records must be ___________ . 1. thoroughly investigated 2. recalculated 3. ignored 4. none of the above

thoroughly investigated

E How long should components, containers, and closures be stored under quarantine before they are available for use? 1. 30 days 2. 60 days 3. 90 days 4. until they have been tested (or examined) and released

until they have been tested (or examined) and released

Subpart G Finish the sentence: Labeling and packaging materials shall be representatively sampled, and examined or tested... 1. Upon receipt and storage of the labels and packaging material. 2. upon identification and before use in packaging or labeling of a drug product. 3. while in use in packaging or labeling of a drug product. 4.upon receipt and before use in packaging or labeling of a drug product.

upon receipt and before use in packaging or labeling of a drug product.

I Written established laboratory control procedures are required to determine conformance to predetermined specifications. Which of the following is not included as required in Subpart I? 1. incoming shipments of components, drug product containers, closures, and labeling material 2. validation of buildings and training of personnel 3. final drug products 4. calibration of equipment 5. in-process material

validation of buildings and training of personnel

F According to the section concerning the charge in of components... Components for drug product manufacturing shall be _____________ as appropriate. (Select ALL that apply) 1. quality assured 2. visually examined 3. processed 4. kept undisturbed 5. weighed 6. measured 7. subdivided 8. quality controlled

weighed measured subdivided

E How are received shipments of components, containers, or closures identified? 1. by like components, containers, and closures 2. with a distinctive code for each lot, i.e. a lot number. 3. shipment received date to use the oldest stock first 4. by each disposition of the lot.

with a distinctive code for each lot, i.e. a lot number.

Subpart G There shall be __________ procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be __________. 1. written, followed 2. detailed, followed 3. written, used 3. detailed, used

written, followed

Subpart C There shall be __________ procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such __________ procedures shall be __________. 1. written, written, adhered to 2. complete, written, used 3. accurate, accurate, followed 4.written, written, followed

written, written, followed