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

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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 (2022) – Manufacture of Sterile Medicinal Products
PIC/S Publications
Svenska Läkemedelsverket – Avvikelser funna vid inspektion av tillverkare och partihandlare
Swiss Medical Inspectorate Interpretation of GMP Annex 1 2022 (Rev. 1)


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 Reviewers 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FDA Draft Guidance for Industry INDs – Approaches to Complying with cGMP during Phase 1
FDA Draft Guidance for Industry, Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients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
ICH Guideline – GMP Guidance for Active Pharmaceutical Ingredients – Q7
ICH Guideline – Quality Risk Management – Q9