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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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