U.S.F.D.A.

ANAMIKA SINGH
M. PHARM
QUALITY ASSURANCE
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
 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-ORGANIZATIONS

 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 AUTHORITIES
 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
 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

 Protecting Consumers
 Promoting Public Health
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.
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 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 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 .

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.
► 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 .
► 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
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…).
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 21
 C.F. R – Code of federal Regulation 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
 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 Labeling.
 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.
 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
FDA GUIDELINES TO CONDUCT CGMP IN PHARMA
INDUSTRY
 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 210
 210.1- 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- Organization and Personnel:
211.22-Responsibility of quality control unit.
211.25-Personnel qualification.
211.28-Personnel responsibility.
211.34-Consultants
► 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 facilities
211.56-Sanitization
211.58-Maintenance
► Subpart D- Equipment:
211.63- Equipment design, size and location.
211.65- Equip. construction
211.67- Equip. cleaning and maintenance
211.68- Automatic, mechanical and electronic Equipment
211.72- Filters.
► 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
► Subpart F-Production 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 production
211.113-Control on microbiological contamination
211.115- Reprocessing
► Subpart G-Packing and labeling control
211.122- Material examination and usage criteria
211.125-Labelling issuance
211.130-Packing and labeling operation
211.132-Tamper evident packing required for OTC Drug product
211.134-Drug product inspection.
211.137-Expiration dating
► 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
► Subpart J-Record and reports:
211.180- General requirement
211.182- Equip. cleaning and use log
211.184- Component, drug product container & labeling records
211.186- Master production and control records
211.188- Batch production and control records
211.192- Production record review
211.194- Laboratory records
211.196- Distribution records
211.198- Complaint files.
►Subpart K- Returned and salvaged drug product:
211.204- Returned drug product
211.208- Drug product salvaging.
THANK YOU