Drugs

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances

CategoryTitleTypeDate
Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Final Guidance 02/01/89
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Final Guidance 11/22/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Medical Gases (PDF - 327KB) Draft Guidance 05/06/03
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 92KB) Final Guidance 07/14/08
Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 89KB) Final Guidance 06/27/97
Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 31KB) Draft Guidance 05/31/05
Pharmaceutical Quality/Manufacturing Standards (CGMP) Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB) Final Guidance 01/11/06
Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19KB) Final Guidance 04/05/01
Pharmaceutical Quality/Manufacturing Standards (CGMP) Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB) Final Guidance 06/25/13
Pharmaceutical Quality/Manufacturing Standards (CGMP) Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 86KB) Final Guidance 10/11/06
Pharmaceutical Quality/Manufacturing Standards (CGMP) Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF - 156KB) Final Guidance 04/10/12
Pharmaceutical Quality/Manufacturing Standards (CGMP) Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (PDF - 70KB) Final Guidance 04/17/13
Pharmaceutical Quality/Manufacturing Standards (CGMP) PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 211KB) Final Guidance 09/29/04
Pharmaceutical Quality/Manufacturing Standards (CGMP) PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB) Final Guidance 12/09/09
Pharmaceutical Quality/Manufacturing Standards (CGMP) and Small Entity Compliance Guide PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB) Final Guidance 08/04/11
Pharmaceutical Quality/Manufacturing Standards (CGMP) Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB) Final Guidance 08/06/09
Pharmaceutical Quality/Manufacturing Standards (CGMP) Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB) Final Guidance 08/23/99
Pharmaceutical Quality/Manufacturing Standards (CGMP) Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB) Final Guidance 11/01/92
Pharmaceutical Quality/Manufacturing Standards (CGMP) Process Validation: General Principles and Practices (PDF - 372KB) FINAL Guidance 01/24/11
Pharmaceutical Quality/Manufacturing Standards (CGMP) Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 363KB) Final Guidance 09/27/06
Pharmaceutical Quality/Manufacturing Standards (CGMP) Questions and Answers on Current Good Manufacturing Practices for Drugs Final Guidance 12/21/11
Pharmaceutical Quality/Manufacturing Standards (CGMP) Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB) Final Guidance 09/29/04
Pharmaceutical Quality/Manufacturing Standards (CGMP) Testing of Glycerin for Diethylene Glycol (PDF - 36KB) Final Guidance 05/01/07
Pharmaceutical Quality/Manufacturing Standards (CGMP) The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF - 127KB) Final Guidance 01/26/10
Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers Final Guidance 06/28/12
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 223KB) Draft Guidance 07/01/14
Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products Current Good Manufacturing Practice Requirements for Combination Products 01/27/15
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 227KB) Draft Guidance 02/13/15
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 127KB) Draft Guidance 02/13/15
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) Draft Guidance 04/14/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Request for Quality Metrics. Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) Draft Guidance 06/24/16

Page Last Updated: 11/23/2016
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