Current Good Manufacturing Practices (CGMPs)/Compliance
and Chemistry, Manufacturing, and Controls (CMC)
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Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)
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Draft Guidance
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09/05/03
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Current Good Manufacturing Practices (CGMPs)/Compliance
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COMPRESSED MEDICAL GASES GUIDELINE
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Final Guidance
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02/01/89
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Computerized Systems Used in Clinical Trials (PDF - 53KB)
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Final Guidance
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05/10/07
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Current Good Manufacturing Practice for Combination Products (PDF - 350KB)
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Draft Guidance
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10/04/04
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Current Good Manufacturing Practice for Medical Gases (PDF - 437KB)
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Draft Guidance
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05/06/03
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
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Final Guidance
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07/14/08
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB)
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Final Guidance
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05/04/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 89KB)
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Final Guidance
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06/27/97
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19KB)
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Draft Guidance
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05/31/05
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB)
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Final Guidance
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01/11/06
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Good Laboratory Practice Regulations Questions and Answers (PDF - 2.2MB)
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Final Guidance
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03/02/98
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19KB)
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Final Guidance
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04/05/01
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Current Good Manufacturing Practices (CGMP's)
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Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 175KB)
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Draft Guidance
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02/10/12
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 98KB)
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Final Guidance
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10/11/06
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Current Good Manufacturing Practices (CGMPs)/Compliance
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Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
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Draft Guidance
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04/17/98
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 164KB)
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Final Guidance
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09/19/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF - 156KB)
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Final Guidance
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04/10/12
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Current Good Manufacturing Practices (CGMPs)
|
Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)
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Draft Guidance
|
03/14/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF - 3.5MB)
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Final Guidance
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03/02/98
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215KB)
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Final Guidance
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09/03/03
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315KB)
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Final Guidance
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09/29/04
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)
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Final Guidance
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12/09/09
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Current Good Manufacturing Practices/Compliance and Small Entity Compliance Guide
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PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB)
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Final Guidance
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08/04/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB)
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Final Guidance
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08/06/09
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Pharmacy Compounding -- Compliance Policy Guide (PDF - 793KB)
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Final Guidance
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05/01/02
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
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Final Guidance
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08/23/99
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 297KB)
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Draft Guidance
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11/07/03
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment: Revised Attachments (PDF - 159KB)
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Draft Guidance
|
11/01/03
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
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Final Guidance
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11/01/92
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38KB)
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Final Guidance
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03/01/06
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB)
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Final Guidance
|
11/13/06
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Process Validation: General Principles and Practices (PDF - 292KB)
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FINAL Guidance
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01/24/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443KB)
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Final Guidance
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09/27/06
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Questions and Answers on Current Good Manufacturing Practices (CGMP) for Drugs
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Final Guidance
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12/21/11
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Review of FDA's Implementation of the Drug Export Amendments of 1986 (PDF - 2MB)
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Final Guidance
|
11/01/89
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB)
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Final Guidance
|
09/29/04
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Street Drug Alternatives (PDF - 11KB)
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Final Guidance
|
03/01/00
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
Testing of Glycerin for Diethylene Glycol (PDF - 36KB)
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Final Guidance
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05/01/07
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Current Good Manufacturing Practices (CGMPs)/Compliance
|
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF - 127KB)
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Final Guidance
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01/26/10
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Guidance for Industry: Bar Code Label Requirements (PDF - 72KB)
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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
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Draft Guidance
|
07/03/12
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Current Good Manufacturing (CGMP's) Compliance
|
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers
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Final Guidance
|
06/28/12
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