Code of Federal Regulations (FDA) and GMP
The documents below contains Code of Federal Regulations, EU GMP:n and regulations for API, Sterile Processing and Validation.
Codes of Federal regulations (CFR) - USA
CFR - Codes of Federal regulations, USA
21 Food and
Drugs
21 CFR 58 - Good Laboratory Practice for Nonclinical
Laboratory Studies
21 CFR 210 - cGMP in Manufacturing, Processing, Packing, or
Holding of Drugs, General
21 CFR 211 - cGMP for Finnished Pharmaceuticals
21 CFR 606
- cGMP for Blood and Blood Components
21 CFR 803 - Medical Device
Reporting
21 CFR 806 - Medical Devices; Reports of Corrections and
Removal
21 CFR 809 - In Vitro Diagnostic Products for Human Use
21 CFR 820 - Quality System Regulation, Medical Device
21 CFR 1271 - Human Cells, Tissues, and Cellular and
Tissue-based Products
European GMP
Eudralex - The Rules Governing Products in the European
Union
Eudralex Vol 4 - Medicinal Products for Human and Veterinary
Use: Good Manufacturing Practice
Eudralex Vol 4, Annex 1 - Manufacture of Sterile Medicinal
Products
PIC/S Publications
Svenska Läkemedelsverket - Avvikelser funna vid inspektion av
tillverkare och partihandlare
Pharmaceuticals - API
EU Annex 15 - Qualification and Validation
FDA Guideline
on General Principles of Process Validation
FDA
Guidance for Industry, Changes to an approved NDA or ANDA
FDA
Guidance for Industry, Investigators, and Prviewers Exploratory IND
Studies
FDA Draft Guidance for Industry INDs - Approaches to Complying
with cGMP during Phase 1
FDA Draft
Guidance for Industry, Manufacturing, Processing, or Holding Active
Pharmaceutical Ingredients
FDA Guidance
for Industry for the Submission Documentation for Sterilization Process
Validation in Application for Human and Veterinary Drug Products
FDA
Guidance to Inspecitons of Oral Solid Forms Pre/post Approval Issues for
Development and Validation
FDA
Guidance to Inspections Validation of Cleaning processes
Current Good
Manufacturing Practice Issues on Human Use Pharmaceuticals - Human Drug cGMP
Notes
ICH Guideline - GMP Guidance for Active Pharmaceutical
Ingredients - Q7
ICH Guideline - Quality Risk Management - Q9
Sterile Processing
FDA
Aseptic Processing Guideline, 1987
FDA CDRH
Guidance for Sterilants and Disinfectants
FDA Guideline for LAL Test
Validation
FDA Sterile Drugs Products Produced by Aseptic processing
cGMP, 2004
FDA Field Compliance Program- Sterile Drug Process
Inspections
Human Drug cGMP Notes
Recommendation on Sterility Testing
Recommendation on the Validation of Aseptic
Processes
Recommendation - Isolators used for Aseptic Processing and
Sterility testing
Validation
Guide
to Inspections Validation of Cleaning processes
EU - Annex 15: Qualification and Validation
FDA Guideline
on general Principles of Process Validation
FDA Draft
Guidance for Industry; Analytical Procedures and Methods Validation
ICH Guideline
- Validation of Analytical Procedures: Text and Methodology Q2 (R1)