26/27 May 2020
In many cases, the quality of the excipients has an immediate effect on the properties of the finished medicinal products in which they are used. In order to ensure excipient quality, the pharmaceutical manufacturer has to pay special attention to the supply chain and aim at securing it as best as possible. For this, correct and complete quality agreements are of utmost importance.
On this topic, IPEC Europe, the European branch of the International Pharmaceutical Excipients Council, has recently published a document titled "The IPEC Quality Agreement Guide and Template". This document includes two templates for a quality agreement: one for the excipient manufacturer (Manufacturer's Quality Agreement Template) and one for distributors or suppliers (Distributor's Quality Agreement). Both documents have the following structure:
3. Manufacturing, Packaging and Labeling'
4. Documentation and Records
5. Storage and Distribution
6. Change Control
9. Quality Contacts
12. List of Attachments
Similarly as in the case of quality agreements with active pharmaceutical ingredients manufacturers, chapters 2 through 8 are checklists. The text indicates the IPEC-PQG GMP Guide as the compliance standard for excipients manufacturers and the IPEC Good Distribution Practices Guide as that for distributors; alternative standards can be enclosed as annexes by the contractual partners.
These two templates include the most important points necessary for an agreement on the quality of excipients and certainly represent a valuable tool within the framework of business relationships between excipient manufacturer and user. In the introduction to this guideline, the IPEC suggests that the active pharmaceutical ingredient manufacturers or suppliers first create a quality agreement on the basis of these templates and, with that, enter into negotiations with their customers. A modification of this agreement should then be carried out with care and attention in order not to protract the negotiations too much. The IPEC expressly recommends a final review by the legal departments of the contractual partners in question.
The complete "IPEC Quality Agreement Guide and Template" can be found here.
The topic "Quality Agreements" is one of the subjects of the trainin course"GMPs for Pharmaceutical Excipients", taking place in Vienna on 20-21 October 2009. This event is co-sponsored by IPEC and the European QP Association.
Dr Gerhard Becker
On behalf of the European Compliance Academy