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

                         CATEGORY                             TITLE
Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF – 123KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Medical Gases (PDF – 219KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF – 92KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF – 89KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF – 72KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF – 66KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities – FDA Public Health Advisory (PDF – 19KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF – 60KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF – 86KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF – 156KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (PDF – 70KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF – 211KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) PET Drug Products – Current Good Manufacturing Practice (CGMP) (PDF – 399KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) and Small Entity Compliance Guide PET Drugs–Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF – 229KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Pharmaceutical Components at Risk for Melamine Contamination (PDF – 137KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF – 8KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Preparation of Investigational New Drug Products (Human and Animal) (PDF – 795KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Process Validation: General Principles and Practices (PDF – 372KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF – 363KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Questions and Answers on Current Good Manufacturing Practices for Drugs
Pharmaceutical Quality/Manufacturing Standards (CGMP) Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF – 734KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Testing of Glycerin for Diethylene Glycol (PDF – 36KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF – 127KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers
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)
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products Current Good Manufacturing Practice Requirements for Combination Products
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF – 556KB)
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF – 646KB)
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF – 340KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF – 120KB)
Pharmaceutical Quality/Manufacturing Standards (CGMP) Request for Quality Metrics. Technical Specifications Document: “Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF – 114KB)

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