GMP Guidelines - Downloads
FDA cGMP
- US cGMP Guide Drugs 21 CFR Part 210 Current Good Manufacturing Practice
- US cGMP Guide Drugs 21 CFR Part 211 Current Good Manufacturing Practice
- US cGMP Guide Medical Devices 21 CFR Part 800 Medical Devices - General
- US cGMP Guide Medical Devices 21 CFR Part 820 - Quality System Regulation
- US cGMP Guide Combination Products 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products
- US cGMP Guide Biologics 21 CFR 600 - Biological Products: General
- US cGMP Guide Biologics 21 CFR 606 - Current Good Manufacturing Practice for Blood and Blood Components
- US cGMP Guide Biologics 21 CFR 610 - General Biological Products Standards
- FDA Regulations Guideline List Human Drugs
- FDA Regulations Guideline List Biologics
- FDA Regulations Guide to Inspections
- FDA Regulations Warning Letters
- FDA Regulations Electronic Records and Signatures (Part 11)
GMP Guides from Industry Organisations
Others
Documents have to be ordered
Documents can be downloaded
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others