6. Quality assurance--good manufacturing practices.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS: Forty-second report)

6.1 Good manufacturing practices for active pharmaceutical ingredients

6.1.1 Proposal for revision: WHO GMP for APIs

Based on feedback received during informal consultations and from the WHO Prequalification Programme, discussions had been held on new approaches and risk evaluation for manufacture of medicines and specifically as to whether the current WHO GMP for APIs should be revised to bring them into line with the ICH GMP guide for APIs (reference ICH Q7).

Both texts were available on the following web sites:

* WHO good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). Printed version: WHO good manufacturing …