T.

RAJARAO, INTERTECHLABS
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Guidance for Industry

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 quality and purity characteristics that they purport, or are represented, to
possess.

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality
system that is based on International Standards Organization (ISO) quality concepts,
includes applicable Good Manufacturing Practice (GMP) regulations and complements
ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH
Q10 is a model for a pharmaceutical quality system that can be implemented
throughout the different stages of a product lifecycle. Implementation of ICH Q10
throughout the product lifecycle should facilitate innovation and continual
improvement and strengthen the link between pharmaceutical development and
manufacturing activities.
Applicability of Q7 to vaccines is very limited that includes
following