| 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) |
