Companies who manufacture excipients for use by pharmaceutical finished dose manufacturers are facing an uncertain regulatory environment as the European Commission draws up its Good Manufacturing Practice Directive for ‘certain’ excipient products.

The overhaul of pharmaceutical legislation by the European Commission in 2004 has brought in GMP requirements for active ingredients and made the development of a Directive on GMP for excipients inevitable.

“There is a clear mandate in the legislation for a Directive on GMP for certain excipients,” said Sabine Atzor of the European Commission’s EG Industry and Enterprise, at an IPEC seminar in Cannes, France. held to launch a new industry-developed guide on GMP for excipients.

A critical stage in the consultation period for the Excipients Directive is just about to get underway with the publication of a questionnaire – developed by the Commission with the help of industry – that will try to establish what quality systems are already being used by companies manufacturing and supplying pharmaceutical excipients in the absence of a legislative framework.

This questionnaire will help the Commission develop its GMP guidance for excipients, and crucially will help it assess the impact of legislation on suppliers and the pharmaceutical finished dose manufacturers.

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.

But she stressed that the Commission is determined to avoid ‘gold-plating’ legislation, and assured delegates that the intention was not simply to apply the existing GMP requirements for active substances used as starting materials – Part II of the Human Medicinal Products Directive (2004/27/EC).

“GMP principles will be adapted for excipients – we will not work with existing requirements,” said Dr Atzor, noting that one possibility is that excipients are dealt with in a separate document – perhaps to be called Part III – that will cover those excipients selected for inclusion in the Directive.

The aim of the guide is help excipient suppliers meet the increasingly stringent demands of the pharmaceutical industry, but also make it easier for pharma companies to ensure their suppliers are meeting acceptable quality levels.