Guidance Notes for GMP Inspections of API Manufacturers and Handlers

This document (guide) is intended to provide guidance regarding good manufacturing practices (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. In this guide “manufacturing” isdefined to include all operations of receipt of materials, production, packaging, repackaging, labelling, re-labelling, quality control, release, storage and distribution of APIs and the related controls.

In this guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.

The guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.

This guide is not intended to define registration and filing requirements or modify pharmacopoeial requirements. This guide does not affect the ability of the responsible regulatory agency to establish specific registration or filing requirements regarding APIs within the context of marketing or manufacturing authorizations or pharmaceutical applications. All commitments in registration and filing documents must be met.

It is hoped that this guideline will go a long way in assuring the quality of APIs imported and/or manufactured and used in the country and by extension assure the quality of finished pharmaceutical dosage forms manufactured in Kenya.