USFDA:- Pharmaceutical Quality/Manufacturing Standards (CGMP)

Pharmaceutical Quality/Manufacturing Standards (CGMP)

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

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Category	Title	Type	Date
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Quality/Manufacturing Standards (CGMP)	Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 86KB)	Draft Guidance	05/24/13
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Quality/Manufacturing Standards (CGMP)	Current Good Manufacturing Practice for Medical Gases (PDF - 327KB)	Draft Guidance	05/06/03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Standards (CGMP)	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 31KB)	Draft Guidance	05/31/05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	Request for Quality Metrics Guidance for Industry (PDF - 250KB)	Draft Guidance	07/27/15