U.S.F.D.A.

By- Prashant TiwariM.Pharma. (Pharmaceutics)

Columbia Institute of Pharmacy, Raipur, C.G.

Introduction The Food and Drug Administration (FDA or

USFDA) is an agency of the United States Department of Health and Human Services

It is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics

Cont….The FDA has its headquarters at White Oak, Maryland.

The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands and Puerto Rico.

In 2008, the FDA started opening offices in foreign

countries, including China , India , Costa Rica , Chile , Belgium and the United Kingdom.

FDA-Organisations

The Office of the Commissioner (OC)

The Center for Drug Evaluation and Research (CDER)

The Center for Biologics Evaluation and Research (CBER)

The Center for Food Safety and Applied Nutrition (CFSAN)

The Center for Devices and Radiological Health (CDRH)

The Center for Veterinary Medicine (CVM)

The National Center for Toxicological Research (NCTR)

The Office of Regulatory Affairs (ORA)

FDA-Legal Authoritys1902 – Biologics Control Act

1906 – Pure Food and Drug Act

1938 – Federal Food, Drug, and Cosmetic Act

1944 – Public Health Service Act

1951 – Food, Drug, and Cosmetics Act Amendments

1962 – Food, Drug, and Cosmetics Act Amendments

1966 – Fair Packaging and Labeling Act

1976 – Medical Device Regulation Act

1987 – Prescription Drug Marketing Act 

Cont…..1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act

(MDUFMA) 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act

of 2007

FDA- Mission

Maintaining of FDAThe FDA consists of employees drawn from a wealth of

science and public health professions. Biologists,

physicians, chemists, biomedical engineers, toxicologists,

pharmacologists, veterinarians, and specialists in the

public health education and communication.

FDA employs approximately 11,516 people who work in

locations around the United States.

FDA regulate?Foods, except for most meat and poultry products, which are

regulated by the U.S. Department of Agriculture. Food additives Infant formulas ,Dietary supplements Human drugs Vaccines, blood products, and other biologics Medical devices, from simple items like tongue depressors, to

complex technologies such as heart pacemakers.Electronic products that give off radiation, such as microwave

ovens and X-ray equipment. Cosmetics. Feed, drugs, and devices used in pets, farm animals, and other

animals. Tobacco products

FDA shares the responsibility for regulating these products with other government agencies:

Pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency regulate these).

Water (FDA regulates the labeling and safety of bottled water, while the Environmental Protection Agency develops national standards for drinking water from municipal water supplies).

Job of the FDA

The FDA is the U.S. Government agency that oversees

most foods and medical products.

Its job is to make sure that: Food is safe, healthy, and

clean. Medicines and medical devices are reasonably safe

and effective. Cosmetic products are safe. Animal foods

and drugs are safe. Food and medical products have

proper labels.

Regulatory programsThe programs for safety regulation vary widely by the

type of product, its potential risks, and the regulatory powers granted to the agency.

The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.

Inspection observations are documented on Form 483 .

FDA Inspection► FDA inspects manufacturers or processors of FDA-

regulated products to verify that they comply with relevant regulations.

► Inspection include:

vaccine and drug manufacturers blood banks food processing facilities dairy farms animal feed

processors Facilities that conduct studies in people (clinical trials). Laboratories that conduct studies in animals or

microorganisms when these studies are used to apply for FDA approval of a medical product.

Foreign manufacturing and processing sites for FDA- regulated products that are sold in the United States. Imported products at the border.

Cont…..► FDA conducts several types of inspections to

help protect consumers from unsafe products

Pre-approval inspection after a company submits an application to FDA to market a new product.

Routine inspection of a regulated facilityFor-cause inspection to investigate a specific

problem that has come to FDA ’ s attention. ►FDA makes available to the public certain

frequently requested records of inspections in an electronic reading room .

Cont…..► Review of FDA inspectional guidesInvestigations Operations Manual (IOM)Compliance Program Guidance Manuals

(CPGM) Compliance Policy Guides(CPG)

► Inspection Technical Guides Review of firm’s Establishment Inspection Report (EIR)

► Responses to FDA Form 483 etc.

► Planning of inspections

Forms Commonly Used During FDA InspectionsFDA Form 482: Notice of inspection. FDA Form 483: Inspectional

observations. FDA Form 484: Receipt for physical

evidence (e.g., samples) , but not for documentary evidence (e.g., label, copy of records…).

Recall?A recall is when a product is removed from

the market or a correction is made to the product because it is either defective or potentially harmful.

Sometimes a company discovers a problem and recalls a product on its own.

Other times a company recalls a product after FDA raises concerns

CFR Title 21C.F. R – Code of federal Regulaion is a codification of

general rules and regulations also known as administrative law published in the federal register by the executive department and agencies of federal government of united states

Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

CFR 21 was received from the Government Printing Office (GPO) and contains the most recently received revision.

Food and Drugs: Parts 1 to 1499 different types of parts to food, drug , cosmetic and medical devices and etc

Cont…..21 CFR part 11- Electronic submission and Electronic

signature 21 CFR part 50- Protection of human subjects 21 CFR part 54- Financial Disclosure by Clinical

Investigators 21 CFR part 56- Institutional Review Board 21 CFR part 101-Food Labelling.21 CFR part 104-Nutritional quality guidelines for foods21 CFR part 106- Infant Formula Quality Control

Procedures21 CFR part 110- Cgmp Practices in manufacturing

packing or holding human food.

Cont…..21 CFR part 210- Cgmp Practices in manufacturing,

packing or holding of Drugs:General 21 CFR part 211- Cgmp Practices for finished

pharmaceuticals21 CFR part 225- Cgmp Practices for medicated

feeds.21 CFR part 312- Investigational new drug

application 21 CFR part 314- Application for FDA Approval to

Market a New Drug21 CFR part 600 to 680- For biological products

FDA Guidelines to conduct cGMP in Pharma Indutry21 CFR part 210- Cgmp Practices in

manufacturing, packing or holding of Drugs:General

21 CFR part 211- Cgmp Practices for finished pharmaceuticals

21 CFR 210210.1- Status of Cgmp regulation.210.2-Applicability of Cgmp

regulation.210.3- Definitions.

21 CFR 211► Subpart A- General provision:211.1-scope

► Subpart B- Organisation and Personnel:

211.22-Responsibility of quality control unit.

211.25-Personnel qualification.

211.28-Personnel responsibility.

211.34-Consultants

21 CFR 211► Subpart C- Building and facilities:211.42-Design and construction features.

211.44-Lighting

211.46-Ventilation,air filtration,air heating and cooling

211.48-Plumbing

211.50-Sewage and refuse.

211.52- Washing and toilet facilites

211.56-Sanitization

211.58-Maintenance

21 CFR 211► Subpart D- Equipment:211.63- Equip. design,size and location.

211.65- Equip. constrution

211.67- Equip. cleaning and maintenance

211.68- Automatic,machanical and electonic Equip.

211.72- Filters.

21 CFR 211► Subpart E- Control of components ,

drug product container and closures:211.80- General requirement

211.82- Receipt & storage of untested components

211.84-Testing of approval or rejection of components

211.86-Use of approved components

211.87- Retesting of approved components

211.89- Rejected components

211.94- Drug product container and closures

21 CFR 211► Subpart F-Prodution and process controls:211.100- Written procedure and deviation

211.101- Charge in of components

211.103- Calculation of yield

211.105- Equip. identification

211.110- Sampling and testing of in-process drug product

211.111- Time limitation on prodution

211.113-Control on microbiological contamination

211.115- Reprocessing

21 CFR 211► Subpart G-Packing and labelling control211.122- Material examination and usage criteria

211.125-Labelling issuance

211.130-Packing and labelling operation

211.132-Tamper evident packing requi.for OTC Drug product

211.134-Drug product inspection.

211.137-Expiration dating

21 CFR 211► Subpart H-Holding &Distribution:211.142- Ware house procedure

211.150- Distribution procedure

► Subpart I- Laboratory control:211.160- General requirement

211.165-Testing and release for distribution

211.166-Stability testing

211.167- Special testing requirement

211.170- Reserve samples

211.173- Laboratory animals

21 CFR 211► Subpart J-Record and reports:211.180- General requirement

211.182- Equip. cleaning and use log

211.184- Component, drug product container & labelling records

211.186- Master prodution and control records

211.188- Batch prodution and control records

211.192- Prodution record review

211.194- Laboratory records

211.196- Distribution records

211.198- Complaint files.

21 CFR 211► Subpart K- Returned and salvaged drug

product:211.204- Returned drug product

211.208- Drug product salvaging.

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