Drugmakers Have Less Than Eight Months to Meet EU Requirements for Excipients

Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission.

The guidelines — which must be met by March 21, 2016 — require marketing authorization holders to assess their entire supply chains to identify risks to the safety and stability of excipients from their source through to their incorporation in finished dosage forms.

Risks to consider include the potential for viral contamination, the potential for endotoxin or pyrogen contamination, sterility assurance for excipients claimed to be sterile and supply chain complexity, among others. Drugmakers should also consider such issues as the formulation and use of the product containing the excipient, the proportion of excipient in the drug’s composition, daily patient intake and whether the excipient is a composite.

Once the excipient’s risk profile is established, drugmakers should determine the GMP controls necessary to ensure the safe use of the excipient. A gap analysis of the expected GMP and the performance and capabilities of the excipient manufacturer should then be performed, the guidelines say. 

Drugmakers will need to document the steps they take to maintain excipient quality and incorporate the excipient risk assessment/risk management procedure in their pharmaceutical quality system.

IPEC Europe says many drugmakers and excipient suppliers won’t be able to meet the 2016 deadline. The group is particularly worried that manufacturers of substances not typically produced as drug excipients may need more time to comply.

IPEC is developing a “how-to” guide to help drugmakers and suppliers establish appropriate GMPs for excipients before the deadline.

In April, the FDA said it is moving forward with requiring pharmaceutical excipient makers to adhere to GMPs and adopt quality systems.

Read the excipients guidelines at www.fdanews.com/07-29-15-EUExcipients.pdf. — Kellen Owings