Q7 Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients (APIs)
The ICH Harmonised Guideline was finalized under Step 4 in November 2000. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
This Guideline applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.
____________________________
Date of Step 4: 10 November 2000
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients (APIs)
The document was finalized under Step 4 in June 2015.
Experience gained with the implementation of the ICH Q7 Guideline since its finalization in 2000 showed that uncertainties related to the interpretation of some sections exist.
Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Questions and Answers document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties, and to harmonise the inspections of both small molecules and biotech APIs.
_______________________
Date of Step 4: 10 June 2015
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
