Drugs

Current Good Manufacturing Practices (CGMPs)/Compliance

Below is a sortable listing of Current Good Manufacturing Practices (CGMPs)/Compliance Guidances

Category	Title	Type	Date
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- Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)	Draft Guidance	09/05/03
Current Good Manufacturing Practices (CGMPs)/Compliance	COMPRESSED MEDICAL GASES GUIDELINE	Final Guidance	02/01/89
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Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Combination Products (PDF - 350KB)	Draft Guidance	10/04/04
Current Good Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Medical Gases (PDF - 437KB)	Draft Guidance	05/06/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)	Final Guidance	07/14/08
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)/Compliance	Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 89KB)	Final Guidance	06/27/97
Current Good Manufacturing Practices (CGMPs)/Compliance	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19KB)	Draft Guidance	05/31/05
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	Good Laboratory Practice Regulations Questions and Answers (PDF - 2.2MB)	Final Guidance	03/02/98
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Practices (CGMP's)	Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 175KB)	Draft Guidance	02/10/12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	Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 98KB)	Final Guidance	10/11/06
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	Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 164KB)	Final Guidance	09/19/11
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 (CGMPs)	Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)	Draft Guidance	03/14/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF - 3.5MB)	Final Guidance	03/02/98
Current Good Manufacturing Practices (CGMPs)/Compliance	Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215KB)	Final Guidance	09/03/03
Current Good Manufacturing Practices (CGMPs)/Compliance	PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315KB)	Final Guidance	09/29/04
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/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	Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB)	Final Guidance	08/06/09
Current Good Manufacturing Practices (CGMPs)/Compliance	Pharmacy Compounding -- Compliance Policy Guide (PDF - 793KB)	Final Guidance	05/01/02
Current Good Manufacturing Practices (CGMPs)/Compliance	Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)	Final Guidance	08/23/99
Current Good Manufacturing Practices (CGMPs)/Compliance	Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 297KB)	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 - 159KB)	Draft Guidance	11/01/03
Current Good Manufacturing Practices (CGMPs)/Compliance	Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)	Final Guidance	11/01/92
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	Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB)	Final Guidance	11/13/06
Current Good Manufacturing Practices (CGMPs)/Compliance	Process Validation: General Principles and Practices (PDF - 292KB)	FINAL Guidance	01/24/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443KB)	Final Guidance	09/27/06
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	Review of FDA's Implementation of the Drug Export Amendments of 1986 (PDF - 2MB)	Final Guidance	11/01/89
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	Street Drug Alternatives (PDF - 11KB)	Final Guidance	03/01/00
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	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF - 127KB)	Final Guidance	01/26/10
	Guidance for Industry: Bar Code Label Requirements (PDF - 72KB)
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

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Current Good Manufacturing Practices (CGMPs)/Compliance

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