Regelverk – läkemedel

Nedanstående dokument behandlar Code of Federal Regulations, EU GMP:n samt regelverk för API, Steril Processing och 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
Eudralex Vol 4, Draft Annex 1 (2017) – Manufacture of Sterile Medicinal Products

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FDA Draft Guidance for Industry INDs – Approaches to Complying with cGMP during Phase 1
FDA Draft Guidance for Industry, Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients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

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)