Regelverk – läkemedel Nedanstående dokument behandlar: > Codes of Federal regulations (CFR) – USA> European GMP> Pharmaceuticals – API> Sterile Processing> Validation
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Changes to an approved NDA or ANDA FDA Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies FDA Draft Guidance for Industry INDs – Approaches to Complying with cGMP during Phase 1 FDA Draft Guidance for Industry, Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance for Industry for the Submission Documentation for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 InspectionsHuman 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processes EU – Annex 15: Qualification and Validation FDA Guideline on general Principles of Process Validation FDA Draft Guidance for Industry; Analytical Procedures and Methods Validation ICH Guideline – Validation of Analytical Procedures: Text and Methodology Q2 (R1)