Intro to QA and QC

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NSR study protocol

"Not serious risk" devices

SR study protocol

"serious risk" devices

What is true of the 510k process?

-A 510k will be granted if a new device is substantially equivalent to a device that was already in the market prior to 1976 -A 510k is a clearance, not an approval -A 510k will be granted if a new device is substantially equivalent to a marketed device which also got a 510k clearance -A 510k should be filed if significant changes have been made to an earlier approved device

Human Factor

-A discipline that focuses on variables that can affect the performance of individuals using devices. -Medical devices

The Drug importation Act of 1848 requires:

-All medications entering the US to be inspected and analyzed for quality, purity and fitness for medical purposes. -Recognized the US Pharmacopeia (USP) that provides and or sets state-of-the-art standards to ensure the quality of medicines

Active Pharmaceutical Ingredient (API)

-Any substance or mixture of substances intended to be used in the compounding of a drug preparation and that, When used in the production of a drug, becomes an active ingredient of the drug product. -Substances intended to furnish pharmacological activity or other direct effect in the medical diagnosis or treatment

A major benefit of electronic recording is it improves demonstration of compliance to auditors. What is an accepted practice for proper control of electronic records?

-Back up through the company's network and not in a thumb drive -Ensure security to prevent unauthorized access to the system -Store electronic records in a safe repository -Electronic or digital signature software may be employed

Benefits for comapnies maintaining ISO registration

-Certification adds credibility -Conclusions may be drawn -sound decisions can be made -Actions can be taken to improve the business

Benefits of ISO

-Certification adds credibility -Useful data/feedback so that conclusions may be drawn, sound decisions made, actions taken to improve business

Tests for Identity may be:

-Chemical -Biological -Immunological

For ISO 9000 compliance is:

-Compliance is voluntary. -Compliance monitored by paid auditor who provides suggestions for quality

Crisis IUD injuries in the 70s

-Dalkon shield contraceptive intrauterine device. -Promoted infections such as Toxic Shock Syndrome -Led to abortion and infertility

8 components of design control

-Design and Development planning -Design Input -Design Output -Design Review -Design Verification -Design..

Design Review for design control

-Does it meet customer needs -Have procedure/individuals assigned for review -All review activities/results/...

Quality system Regulation

-Equivalent to cGMP for devices

The Biologics control act of 1902 requires:

-Federal government issue pre-market approval for biological drugs -inspection and licensing of any establishment that wants to market a biologic

What is the US Pharmacoeia (USP)?

-First recognized by The Drug importation Act of 1848. -provides and or sets state-of-the-art standards to ensure the quality of medicines

For ISO 9000 standards are:

-Generic -Requires companies to write a quality manual overview of their system

Benefits in external market conditions from ISO registration:

-Higher perceived quality -Competitive advantage -Increased market share -Improved customer demand -Reduced customer quality audits -Quicker time to market

Quality attributes of drugs

-Identity -Purity -Strength -Stability -Consistency -Safety -Efficacy

Raw materials are typically accompanied by a CofA provided by the raw material manufacturer. What is included in the CofA?

-Identity/chemical formula/formula weight of the material -Material Appearance -Signature of the primary manufacturer's QC analyst -Safety Precautions

Benefits in internal operations from ISO registration:

-Improved documentation -Greater quality awareness by employees -Greater operational efficiency and productivity -Enhanced inter-company communications -Reduced scrap/rework expenses

Premarket Approval Application (PMA)

-Innovative devices that is not SE to other devices cleared through 510k -Should provide evidence that device is safe and effective. -Detailed manufacturing section on methods for building and testing device -PAI before approval

What is a data source that would indicate a deficiency in the quality system and thus a need for corrective and preventive action?

-Internal audits -QC test results -customer feedback -service and repair records

ISO ensures conformance by:

-Internal audits -management reviews -customer feedback -corrective and preventive actions -All other measurement information

Devices can be classified as:

-Invasive (implants, stents, pacemakers etc) or -Non invasive (Diagnostic tests and instruments)

Product quality can be insured by complying with:

-Laws-enforcible -Regulations-enforcible -guidances-not meant to be enforceable

820.22 Quality Audit

-Must be performed and results documented -Need for CAPA

Design Input for design control

-Performance characteristics/specifications -Documented, reviewed, approved -Intended use -User/patient/clinical requirements -Human factors -Evaluate components and suppliers -Packaging, labels and user instructions

Quality by Design requirement is discussed in the Pharmaceutical cGMPs for the 21st Century and ICH Q8. What is true of quality by design concept?

-Quality does not stop upon successful release of the first lot of product -QbD compliance is mandatory in both European Union countries and in the US -Quality cannot be tested into the final product -Quality encompasses all aspects of the process and product

For GMP regulations compliance is:

-Required by law -Enforced by FDA inspectors

The Kefauver-Harris Amendments to FFDCA 1962

-Required drug makers to prove safety and efficacy of drug before the FDA will approve commercialization. -Use of term cGMP became prevalent. -1963 was first cGMP became published.

List important early GMPs that resulted from sulfathiazole antibiotic crisis

-Segregation of finished batch until all lab tests are done -Lab controls on testing of raw materials and finished products -Adequate supervision of key equipment

Elixir Sulfanilimide crisis of 1937

-Sulfilanimide used to treat strep infections. -Massemgill began to market a liquid sulfa drug called Elixer Sulfanilamide. -The solvent used was highly toxic antifreeze. -107 ppl died from taking the drug

What is a responsibility of the quality control unit (QA/QC) of a drug manufacturing company?

-Testing of raw materials, in-process materials and finished products -Auditing or inspection of contract manufacturing organizations -Keeps track of manufacturing employee education and training records -Checks for discrepancies in data results in laboratory notebooks and computer records

Which of these manufacturing activities or information is entered into equipment logs?

-The name of the technician using the equipment at a given time -The time an activity started and ended -Whether equipment maintenance or cleaning was or is being performed -The manufacturing process for which the equipment is being used for

Design and Development planning for design control

-Timelines for developmental strategy and reviews. -Deliverables for each stage -Personnel and Responsibility assignments

Premarket Notification or 510K process

-To demonstrate that new device is substantially equivalent to another device that had already gone through 510k process. -Marketing clearance, not an approval. -Required when marketing for the first time, or there is a significant change to existing device

Design Transfer for design control

-Written plan for transfer of design components to manufacturing -Develop manufacturing facilities and utilities -Develop and validate manufacturing process...

What applies to level 3 or qualilty assurance system documents?

-are subject to revisions -includes actual work instructions in the form of standard operating procedures (SOPs) -includes documents that should be in front of workers while conducting certain activities -includes information of approved tests and acceptance or passing criteria

What applies to the qualilty system manual?

-describes regulations that the company is required to follow -presents a summary or menu for all associated plans, protocols , procedures, and specifications -defines the company's organizational structure and designate business expectations -designates compliance requirements and expectations across functional areas, sites, or contractors

Design controls

-does not apply to research, but starts with development process -DC SOP should clearly define the point design controls apply -Applies to most Class II and III devices, a few Class I

ISO members are:

-experts appointed by national standards institutes participating on the technical committee.

Design output for design control

-finished design -Evaluate conformance to input requirements/acceptance criteria -Basis for the device master record (DMR)

What is a major benefit in internal operations that comes with a company being ISO certified?

-greater quality awareness by employees -Improved documentation -greater operational efficiency & productivity -enhanced inter-company communications

ISO 9000

-international standards for a generic management system for quality assurance. -Intended to equalize quality systems between companies and countries

Pure food and drug act prohibited:

-interstate commerce of misbranded and adulterated foods, drinks, and drugs -Mandated label warnings on habit-forming drugs -Had to list habit-forming drugs (11 total) mainly CHAM (cocain, heroin, alcohol, and morphine)

What is part of acceptance activities under quality system regulations?

-receiving and acceptance of device parts from suppliers -receiving and acceptance of raw materials from suppliers -receiving and acceptance of in-process materials during different stages of the manufacturing process -acceptance activities for the finished device

820.25 Personnel

-sufficient personnel with ETE background -Training; identify need, written procedures, document training

The QC group:

-testing components, in-process materials, and finished products -Developing, validating, and performing assays -Proving analytical support for process validation and monitoring

What applies to product risks?

-type of risks that is out of a manufacturer's control -could be due to product preference of customers. -could lead to bad consumer perception -could lead to reduced sales

What are the 3 main pathways for marketing a device

1. 2. QSR 3.

Purity can be assessed at 2 levels:

1. Product Level 2. Process Level

Over the years, the Quality control unit has been broken down into 2 groups:

1. Quality Assurance (QA) 2. Quality Control (QC)

Consistency of product quality is achieved by adherence with 4 on-going processes. What are the 4 processes?

1. Validation 2. Documentation 3. Continuous improvement 4. Testing

Upstream Bioprocess

1. rDNA construction 2. Strain engineering 3. Inoculum Development 4. Media Development 5. Optimization of culture conditions

The ISO system consists of more than:

20,000 systems and guidelines

In the risk management lecture, the highest possible risk score for any given process equals ________, and the lowest possible score equals _______.

27,1

Pareto principle implies that a manufacturer may be able to avoid ________ % of failures by addressing ______ % of the possible causes for failure.

80,20

What is not true of the 510k process?

A 510k application must be submitted to the FDA 120 days before planned marketing date

In 1963 1st set of cGMP published:

A drug...shall be deemed adulterated...if methods do not conform to cGMP requirements such as Safety, Identity, strength, quality, and purity characteristics which it purports to possess

Which device is least likely to be required to comply with quality systems regulations during its development stage?

A machine that measures blood cholesterol levels

Thalidomide Crisis (1962)

A sedative marketed to combat morning sickness for pregnant woman, caused birth defects in infants across Europe. -Resulted in the The Kefauver-Harris Amendments to FFDCA 1962

Patent medicines of early 20th century

Administered as drugs but no proven medical benefit. Sometimes called snake oils. May contain drugs such as cocaine, heroin, and morphine

A drug...shall be deemed ____________________...if...the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding, do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.

Adulterated

The Quality control unit shall have the responsibility and authority to:

Approve or reject all components, containers, closures, in-process materials, packaging material, labeling, and drug products. They are responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. They have the responsibility of approving/rejecting all procedures or specifications

The part of quality risk management that involves thinking of what processes or steps might lead the product to fail specifications is:

Risk identification

2004 changes to Pharmaceutical cGMPs for the 21st century characterized by a_________________approach

Risk-Based

Which component of risk quantification is a measure of risk that a product would fail to meet critical quality attributes requirement?

Severity

The amount of API in a given unit of a drug that is effective and safe for a certain indication is its:

Strength

T/F: Not all marketed devices have been tested for safety and efficacy in human subjects

TRUE

The main objective of ICH is to harmonize the ___________________________________.

Technical requirements for the registration of pharmaceuticals for human use

What lead to the Biologics control act of 1902?

Tetanus contaminated serum from a horse. Serum killed children

In 1930 the name of the FDIA was changed to:

The Food and Drug Administration (FDA)

Which of these manufacturing activities or information is not entered into equipment logs?

The date the equipment was installed

Failure to comply with any applicable provisions of FDA's Quality Systems Regulation in CFR21 Part 820 will render a device adulterated and ______________________ is (are) subject to regulatory action.

The device and person responsible

Which of these statements would best describe the stability attribute of a drug?

The quality of the drug does not change from the time the drug is manufactured to the time it expires

What lead to the enactment of the Drug importation act of 1848?

The quinine crisis in the Mexican American War

Raw materials are typically accompanied by a CofA provided by the raw material manufacturer. What is not included in the CofA?

The recipient company's address

What is true of risk scores?

The ultimate goal of risk scores is to rank the risks so one can prioritize what needs to be focused on.

A major benefit of electronic recording is it improves demonstration of compliance to auditors. What is not an accepted practice for proper control of electronic records?

Use hardware or software that would not show if a change had been made in the recorded test results

What is not part of acceptance activities under quality system regulations?

acceptance of design changes

Strength/Potency is a measure of:

biological activity

______________apply to drugs and devices

cGMPs

_____________apply to both marketed and investigational drugs

cGMPs

What are the most common habit forming drugs regulated by the Pure food and drug act?

cocain, heroin, alcohol, and morphine

Quality is assured by manufacturers adherence to__________.

current good manufacturing practices

What does not apply to level 3 or qualilty assurance system documents?

describes regulations that the company is required to follow

What is not a data source that would indicate a deficiency in the quality system and thus a need for corrective and preventive action?

design input

Unlike drugs, Devices :

do not use chemical action, not dependent on being metabolized by the body, no direct therapeutic effect on the body. Most exert effects locally. Many do not even contact patient

In response to the sulfathiazole antibiotic crisis the FDA:

drastically changed the manufacturing quality controls leading to development of GMPs -These were not actually put into law until after the thalidomide crisis of 1962

ISO system standards are developed by:

experts from business, gov, and other relevant organizations

Records, including complaint files, should be retained:

for the expected life of the device

The FDA drastically changed manufacturing and quality controls in mid 20th century leading to the development of:

good manufacturing practices (GMPs)

ISO 9000 originated:

in Europe; Independent organization

What does not apply to the qualilty system manual?

includes Master Batch records and Executed Batch Records

What is not a major benefit in internal operations that comes with a company being ISO certified?

increased scrap and rework expenses

The latest revisions of ISO 9001 emphasize:

management review and continuous improvement throughout the product's life cycle.

Submission of a________________for a new pharm. or biotech derived product is directed to 1 of 5 centers within FDA

marketing application

For purity at the product level, contaminants:

may cause immunogenic responses in humans

ISO 13485 is for:

medical devices

What least applies to product risks?

pertains to issues that could compromise product yield

ISO members must:

present a consensus position based on the views of their country.

ISO 9001 is for:

quality

ISO 9001 is for:

quality ; emphasizes need for management review and continuous improvement of a product

Adequate laboratories for testing and approval/rejection of components, containers, closures, packaging materials, in-process materials, and drug products shall be available to the:

quality control unit

During the Mexican War of 1848 Soldiers deaths resulting from imported________that turned out to be ineffective against yellow fever

quinine

ICH is committed to:

reducing duplication during research and development of new drugs while safeguarding quality, safety, and efficacy

cGMP includes:

regulations and guidelines applicable for drugs and devices manufactured for human use, including investigational products

In 1933the FDA recommended complete:

revision of the Pure Food and Drugs Act

For GMP regulations standards are:

specific to the industry

In 1901 children died because a___________was used to produce diphtheria antitoxin that killed children

tetanus contaminated serum from a horse

Quality is defined as:

the ability of a product, process, or system to achieve predetermined requirements.

The more potent the drug:

the lower the dose

Laws, regulations, and guidances for quality are used for:

the manufacture, processing, packing, and holding of drug components and the final product

The QA group ensures that:

the manufacturing and laboratory operations are compliant with cGMP regulations

With medical products quality means that:

the product meets the requirements for safety and effectiveness in its intended use

In 1941 Nearly 300 deaths and injuries from sulfathiazole tablets, an antibiotic, tainted with:

the sedative Phenobarbital

Centers within the FDA

CDER-Center for drug evaluation and research CBER-Center for biologics... CDRH-Center for Devices and Radiologic Health -CVM-center for veterinary medicine -CFSAN-Center for Food Safety and Applied Nutrition

cGMPS require compliance with regulations as in:

CFR21 Part 211

CDRH

Center for Devices and Radiological Health; Regulates devices, ensures that commercialized devices are safe and effective; CFR21 Parts 800-1299

___________was appointed to head the new Bureau of Chemistry (BOC) under the US department of agriculture

Charles Wetherill

What is not a responsibility of the quality control unit (QA/QC) of a drug manufacturing company?

Checking accuracy of quarterly or annual earnings reports

Medical device classification system

Classed in classes 1-3

Changes to cGMP published in the:

Code of Federal Regulations (CFR) 21 parts 210 and 211

What applies to ISO9000 but not to GMP regulations?

Compliance is monitored by a paid auditor who provides suggestions for improvement

Which activity is the responsibility of the QC more than that of the QA group?

Conducts stability testing of drug products

Which of these quality attributes is best described by the phrase, "quality should be demonstrated and maintained with each batch or lot manufactured?

Consistency

The primary focus of quality management principles is to meet or exceed _________________ requirements and expectations.

Customer

Which type of record would greatly facilitate the recall of a particular drug batch that has quality issue?

DISTRIBUTION RECORDS

Which of the 8 components of design control involves setting performance characteristics, specifications, and consideration of human factors in the device design?

Design Input

Which of the 8 components of design control involves ensuring that the device conforms to its intended use by testing the performance of initial production units under actual or simulated use conditions?

Design Validation

Safe Medical Devices Act of 1990

Design controls, validation, post-marketing surveillance

According to the International Organization for Standardization (ISO) website a standard is a _______________ that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

Document

In 1990, ICH was established between:

EU, Japan, and US-brings together regulatory agencies and pharmaceutical industries

What quality attribute was added as a requirement for drugs prior to marketing in the Kefauver-Harris Amendments of 1962, but not in the Food Drug and Cosmetic Act of 1938?

Efficacy

Which activity is the responsibility of the QA more than that of the QC group?

Ensures that laboratory and manufacturing operations are compliant with cGMP regulations

Of the four levels of quality documentation, which one would be audited by the FDA to look for evidence that a certain manufacturing process was done according to SOPS?

Executed batch records

cGMPs does not include Acts passed by the:

FDA

CFR Part 820

Final rule on cGMP requirements for medical devices in 1996

Federal Food, Drug, and Cosmetic Act 1938 (FFDCA)?

Focus is on truth in labels. Less focus on efficacy. -Required manufacturers to prove safety before marketing. -Required adequate controls -Required labels with directions -First use of GMPs to set tolerances for toxic substances. -Now the main law used by the FDA to regulate drugs and devices.

In 1927 the BOC became the:

Food, Drug and Insecticide Administration (FDIA)

Consistency of product quality is achieved by adherence with 4 on-going processes. Which is not one of the four?

Frequent SOP changes

What was the first internationally harmonized tripartite GMP guidance?

ICH Q7A

cGMPs include guidelines in:

ICHQ7A

________ contains guidelines for quality risk management.

ICHQ9

The main purpose of ISO9000 is to equalize quality systems between manufacturers and countries. _____________ is the only standard in the ISO9000 family that a company or product can be certified against.

ISO 9001

Which quality attribute is normally established by comparison of immunological activity with reference standards that may be obtained from US Pharmacopeia?

Identity

GMP regulations originated:

In the United States by a federal agency

International Organization for Standardization (ISO)

Independent international organization for the purpose of developing business standards and guidelines for quality

What does ICH stand for?

International Conference on Harmonization -Of technical requirements for the registration of pharmaceuticals for human use

One risk analysis tool is the cause and effect or fishbone diagram shown below. It was devised by_________.

Ishikawa

The use of the term "current Good Manufacturing Practice" first became prevalent in the:

Kefauver-Harris Amendments of 1962

Of the four levels of quality documentation, which one would be audited by the FDA to examine assay results?

Laboratory notebooks of QC analysts

In the Wockhardt warning letter, an operator performed in-process tablet testing with the batch record in a separate room, not where the weights were being measured. The batch record is what level of quality documentation?

Level 4 - Other quality documents

Of the 7 main systems making up the quality systems that are the focus of an FDA's CDRH compliance inspection, which occupies the central and most important position?

Management

Medical Device Regulation act 1976

Medical Device Amendments to..

Medical Device Amendments of 1992

More post marketing surveillance, FDA recalls

What has nothing to do with the Biologics Control Act of 1902?

Morphine and heroine ingredient in patent medicines that killed many infants

Drugs and Devices are recognized in the:

National Fromulary or United States Pharmacopeia

What is an acceptable documentation practice?

Never pre-record information

What did ICH Q7A establish?

One global GMP standard for Active Pharmaceutical ingredients

Quality by Design requirement is discussed in the Pharmaceutical cGMPs for the 21st Century and ICH Q8. What is not true of quality by design concept?

Passing of final drug product specifications is sufficient to assure product quality

With the ______________________________ guidance, FDA announced its desire for manufacturers to integrate quality systems and risk management approaches into its existing programs.

Pharmaceutical cGMPs for the 21st Century

Quality Control unit tests would be against:

Pre-determined specifications and would objectively show that the product is acceptable

Which of these information will be found in both device history record and device master record?

Production flow diagram

What was the first federal law to regulate both food and drugs?

Pure food and drugs act of 1906

Which of these quality attributes can be demonstrated by looking at the number of unwanted peaks using an HPLC?

Purity

What are the main areas of ICH guidelines?

Quality Safety Efficacy Multidiscinplinary

CFR 21 Part 11 contains:

Regulations on electronic recording


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