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The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential.

In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.

This document proposes GMP appropriate for the manufacture of excipients and is a joint initiative between the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), incorporating the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001 with the PQG’s PS 9100:2002 Pharmaceutical Excipients. During guide development, the opportunity was taken to make further clarifications of the text and to ensure alignment with the corresponding clauses in ISO 9001. The top-level headings in Sections 4 to 8 of this document match those in Sections 4 to 8 of ISO 9001 with the exception of Section 4.3 – Change Control. Sub headings have been expanded or reduced from the ISO 9001 structure to provide clarity of text.

This Guide makes an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.

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

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