USFDA Guidelines for Pharmaceuticals

By: Pharma Tips | Views: 9291 | Date: 19-May-2015

Current FDA guidelines, FDA process validation guideline, FDA GMP guidance, FDA warning letter, FDA 21 CFR, good manufacturing practices, FDA validation, Good Laboratory Practice Regulations, Expiration Dating and Stability Testing, FDA guide for sterile products, Out of Specification.

USFDA Guidelines for Pharmaceuticals

United State Food and Drug Administration (USFDA) provides the sterile and non sterile pharmaceutical guidelines for industries. USFDA updates these guidelines time to time the provides to their users. All the USFDA approves plants have to follow these guidelines throughout the world.

USFDA provides the pharmaceutical guidelines for all the stages from raw material to finished pharmaceutical products.

USFDA GMP Guidelines:

Category	Title	Type	Date
Current Good Manufacturing Practices (CGMPs)	Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 70KB)	Final Guidance	04/17/13
Current Good Manufacturing Practices (CGMPs) - Compliance	Guidance for Industry: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling	Draft Guidance	07/03/12
Current Good Manufacturing (CGMP's) Compliance	Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers	Final Guidance	06/28/12
Current Good Manufacturing Practices (CGMPs)/Compliance	Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF - 156KB)	Final Guidance	04/10/12
Current Good Manufacturing Practices (CGMP's)	Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 175KB)	Draft Guidance	02/10/12
Current Good Manufacturing Practices (CGMPs)/Compliance	Questions and Answers on Current Good Manufacturing Practices (CGMP) for Drugs	Final Guidance	12/21/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 164KB)	Final Guidance	09/19/11
Current Good Manufacturing Practices/Compliance and Small Entity Compliance Guide	PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB)	Final Guidance	08/04/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB)	Final Guidance	05/04/11
Current Good Manufacturing Practices (CGMPs)	Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)	Draft Guidance	03/14/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Process Validation: General Principles and Practices (PDF - 372KB)	Final Guidance	01/24/11
Current Good Manufacturing Practices (CGMPs)/Compliance	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF - 127KB)	Final Guidance	01/26/10
Current Good Manufacturing Practices (CGMPs)/Compliance	PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)	Final Guidance	12/09/09
Current Good Manufacturing Practices (CGMPs)/Compliance	Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB)	Final Guidance	08/06/09
Current Good Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 92KB)	Final Guidance	07/14/08
Current Good Manufacturing Practices (CGMPs)/Compliance	Computerized Systems Used in Clinical Trials (PDF - 53KB)	Final Guidance	05/10/07
Current Good Manufacturing Practices (CGMPs)/Compliance	Testing of Glycerin for Diethylene Glycol (PDF - 36KB)	Final Guidance	05/01/07
Current Good Manufacturing Practices (CGMPs)/Compliance	Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB)	Final Guidance	11/13/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 86KB)	Final Guidance	10/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 363KB)	Final Guidance	09/27/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38KB)	Final Guidance	03/01/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB)	Final Guidance	01/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 31KB)	Draft Guidance	05/31/05
Current Good Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Combination Products (PDF - 200KB)	Draft Guidance	10/04/04
Current Good Manufacturing Practices (CGMPs)/Compliance	PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 211KB)	Final Guidance	09/29/04
Current Good Manufacturing Practices (CGMPs)/Compliance	Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB)	Final Guidance	09/29/04
Current Good Manufacturing Practices (CGMPs)/Compliance	Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 244KB)	Draft Guidance	11/07/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment: Revised Attachments (PDF - 157KB)	Draft Guidance	11/01/03
Current Good Manufacturing Practices (CGMPs)/Compliance and Chemistry, Manufacturing, and Controls (CMC)	Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 125KB)	Draft Guidance	09/05/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 214KB)	Final Guidance	09/03/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Medical Gases (PDF - 327KB)	Draft Guidance	05/06/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Pharmacy Compounding -- Compliance Policy Guide (PDF - 659KB)	Final Guidance	05/01/02
Current Good Manufacturing Practices (CGMPs)/Compliance	Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19KB)	Final Guidance	04/05/01
Current Good Manufacturing Practices (CGMPs)/Compliance	Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)	Draft Guidance	04/17/98
Current Good Manufacturing Practices (CGMPs)/Compliance	Good Laboratory Practice Regulations Questions and Answers (PDF - 2.2MB)	Final Guidance	03/02/98
Current Good Manufacturing Practices (CGMPs)/Compliance	Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 89KB)	Final Guidance	06/27/97

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