USFDA GUIDLINES

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

1. U.S.F.D.A . 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 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: 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 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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