New Good Practices guide for suppliers of excipients

As the European Commission (EC) prepares the groundwork for drafting a Good Manufacturing Practice (GMP) Directive for specific excipient products, trade alliances in the sector have issued a new GMP guide. Developed by the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG), the guide will also help pharma companies ensure that suppliers are meeting acceptable quality levels.

"The GMP Guide provides a single, authoritative document that, for the first time, provides a harmonised guidance for excipients, set at an appropriate level and up to date," said Pharmaceutical Quality Group's Steve Moss, who is manager of new product supply and business development at GlaxoSmithKline.

The EC has already brought in GMP requirements for active ingredients and the development of a Directive on GMP for excipients is expected. "There is a clear mandate in the legislation for a Directive on GMP for certain excipients," said Sabine Atzor of the EC's EG Industry and Enterprise, at an IPEC Guide launch in Cannes, France.

Excipient suppliers want to ensure the EC strikes the right balance between avoiding risks to public health from quality-impaired products, and avoiding excessive regulation that could put some suppliers out of business. It is hoped that this guide, developed with close consultation between industry, regulators and other stakeholders, on both sides of the Atlantic, will help the EC develop workable, pragmatic legislation on excipients.

A critical stage in the consultation period for the Excipients Directive is about to get underway with the publication of a questionnaire, developed by the EC with the help of industry, that will try to establish what quality systems are already being used by companies. Two versions of the questionnaire will be available: one for excipients manufacturers to gauge what quality standards they are using and what proportion of sales goes to pharmaceutical uses, and another for finished dosage form manufacturers that will examine the qualification and audit systems they operate for excipients manufacturers and distributors.