Direct Links to important GMP API Guidelines

This document provides guidance on change control procedures for equipment, utilities and computerised systems in API facilities.

These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier on a prequalifi ed product (named in the text from now on as product dossier) when the APIMF procedure is used. It is also intended to help APIMF holders in the compilation of their APIMFs.

The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on the good manufacturing practice (GMP) regarding the design, installation and operation of pharmaceutical water systems.

This paper aims to give national authorities sufficient background information on the various orally administered active pharmaceutical ingredients (APIs) on the WHO Model List of Essential Medicines (EML), also taking into account local usage of the API, to enable them to make an informed decision as to whether generic formulations should be subjected to in vivo bioequivalence (BE) studies or whether a biowaiver can be granted.