JOINT IPEC – PQG GOOD MANUFACTURING PRACTICE GUIDE FOR PHARMACEUTICAL EXCIPIENTS 2006
This document represents voluntary guidance for the pharmaceutical excipient industry and the contents should not be interpreted as regulatory requirements. Alternatives to the approaches in this Guide may be used to achieve an equivalent level of assurance for excipient quality.
INTRODUCTION 1.1 Purpose and Scope
This document is an internationally accepted Guide that defines the extent and point of application of appropriate Good Manufacturing Practice (GMP) principles for excipient manufacture. The Guide is applicable to the manufacture of excipients intended for use in drug products. It covers the quality management system and the extent of GMP necessary throughout manufacturing for both batch and continuous processes. It will assist both auditors and manufacturers to establish whether the facilities and controls used for the manufacture of excipients are adequate and whether the excipients possess the quality and purity which they purport to possess and are suitable for their intended use.
The manufacture of certain excipients for specialist applications presents additional challenges that are outside of the scope of this Guide. Examples include excipients;
for parenteral, ocular, inhalation, open wound use,
that are sterile and/or pyrogen free,
In these cases, it is recommended that guidelines and compliance programmes that provide detailed guidance for the manufacture of the related drug products can be consulted and adapted as necessary to the excipient in question.
The Guide does not address the specific GMP relating to Good Trade and Distribution Practices (GTDP). For additional guidance on GMP for distributors refer to the WHO Good trade and distribution practices for pharmaceutical starting materials (see also Appendix C).
The Guide and its Use
Pharmaceutical excipients are diverse and often have uses other than for pharmaceutical applications. Each manufacturer should consider how this Guide might apply to their products and processes (for example batch versus continuous processes). Since excipients are so diverse, some principles of this Guide may not be applicable to certain products and manufacturing processes.
For the purposes of this Guide the terms GMP and current Good Manufacturing Practice (cGMP) are equivalent.
Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group