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The term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative that provides at least an equivalent level of quality assurance. Note that “should” does not mean “must” or “shall”.


Application The text provides the guidance necessary for the manufacture of excipients but not all of the details. As an international guidance document, it cannot specify national legal requirements or cover particular characteristics of every excipient.


Quality System Standard The quality management system standard chosen as a framework for this Guide is ISO 9001, which is appropriate for manufacturing facilities. A manufacturer may apply the ISO standard with or without certification. But this is a business decision and not a recommendation of this Guide. However, ISO certification has the benefit of providing assurance to customers that the excipient manufacturer’s quality management system has been independently verified.

The headings in this document have been aligned with the ISO 9001 clause numbers because many excipient manufacturers already use that standard as a basis for their quality management system. Additional headings are included as required to introduce the additional guidance on GMP when not covered by current ISO 9001 clauses.

IPEC and the PQG believe that merging GMP principles for pharmaceutical excipient manufacturing into the ISO 9001 quality management system enhances not only quality management but also an organisation’s operational procedures.

1.3 Document Structure

This Guide combines the concepts of existing GMP principles from the WHO (World Health Organization) GMP guidelines for excipients, the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients 2001, IQA PQG PS 9100:2002 Pharmaceutical Excipients and international quality management system requirements as developed by the International Organization for Standardization (ISO). In view of the increasing globalisation of the pharmaceutical industry and the harmonisation of pharmaceutical registration requirements, relevant portions of the manufacturing concepts detailed in these schemes are employed throughout this Guide.

Section 3 General Guidance provides an overview of the GMP criteria applicable to excipient manufacture and the point of application of excipient GMP.

Sections 4 to 8 give guidance on the GMP principles and implementation of a quality management system suitable for excipient manufacture. For example these sections recommend measures to limit excipient contamination. No attempt has been made to include details specific to particular excipients. Individual manufacturers should address these as they apply to their own products and processes.

The Appendices cover supporting guidance for excipient GMP including Auditing Considerations (which describes key criteria to be considered when auditing an excipient manufacturing facility), along with Definitions, Glossary and Bibliography.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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