Prashant Tiwari M. Pharm, Pharmaceutics. Columbia Institute of Pharmacy Raipur, C.G.

1. By- Prashant Tiwari
M.Pharma. (Pharmaceutics)
Columbia Institute of
Pharmacy, Raipur, C.G.

2. 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

3. 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.

4. 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)

5. FDA-Legal Authoritys
 1902 – 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

6. 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

7. FDA- Mission

8. Maintaining of FDA
 The 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.

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

10. 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).

11. 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.

12. Regulatory programs
 The 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 .

13. FDA Inspection
FDA inspects manufacturers or processors of FDA-regulated
products to verify that they comply with relevant regulations.
Inspection include:
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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.

14. 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 facility
 For-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 .

15. Cont…..
Review of FDA inspectional guides
 Investigations 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

16. Forms Commonly Used During
FDA Inspections
 FDA 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…).

17. 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

18. CFR Title 21
 C.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

19. Cont…..
 21 CFR part 11- Electronic submission and Electronic
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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 foods
21 CFR part 106- Infant Formula Quality Control
Procedures
21 CFR part 110- Cgmp Practices in manufacturing
packing or holding human food.

20. Cont…..
 21 CFR part 210- Cgmp Practices in
manufacturing, packing or holding of
Drugs:General
 21 CFR part 211- Cgmp Practices for finished
pharmaceuticals
 21 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 Drug
 21 CFR part 600 to 680- For biological products

21. FDA Guidelines to conduct cGMP
in Pharma Indutry
21 CFR part 210- Cgmp Practices in
manufacturing, packing or holding of
Drugs:General
21 CFR part 211- Cgmp Practices for
finished pharmaceuticals

22. 21 CFR 210
210.1- Status of Cgmp regulation.
210.2-Applicability of Cgmp
regulation.
210.3- Definitions.

23. 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

24. 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

25. 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.

26. 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

27. 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

28. 21 CFR 211
Subpart G-Packing and labelling control
211.122- 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

29. 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

30. 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.

31. 21 CFR 211
Subpart K- Returned and salvaged drug
product:
211.204- Returned drug product
211.208- Drug product salvaging.
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32. THANK YOU