Risk Assessment for Ascertaining GMP for Excipients

The EU has published the comments received from the industry regarding the publication of the draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. This document was published by EU Commission in February 2013.

Most of the organisations welcomed the publication but asked for further clarification. The scope of the document does not indicate whether the Guideline will be applicable for Excipients for Medicinal Products only or for Excipients for Investigational Products too. EFPIA has asked for a few more examples which could be developed in a dialogue with the industry. They also proposed to develop a Question and Answer document to provide additional information. EFPIA believes "that it is not necessary to develop additional GMP guidelines for excipients. For instance, reference could be made to, inter alia, IPEC/PQG Excipient Guide 2006 (based on ISO framework). Also, EU-GMPs are established for finished drug products and APIs and not for excipients."

The current draft document not only requires to assess the risk presented by the excipient but it also requires to "rank" the risks. IPEC states in its comments: "Ranking actually serves no useful purpose in this process. Both material and suppliers are assigned a “ranking” but this does not reflect their subsequent control via determination of GMP. It should be removed." IPEC also recommends to remove the requirements to classify the excipients as “low risk”, “medium risk” or “high risk”. According to IPEC, the real reason for performing the assessment is to determine the risk profile and then balancing the level of GMP required against it.

It is up to the EU Commission to develop a final guideline in the next months to come.

All comments can be found at the EU Commission Page (publication date 08 November 2013).