IPEC Releases Quality Agreement Template for Excipients
This article was originally published in The Gold Sheet
Executive Summary
IPEC offers template for excipient quality agreements.
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The International Pharmaceutical Excipients Council-Americas and IPEC Europe issued a template in September for establishing quality agreements between pharmaceutical manufacturers and excipient suppliers. The template highlights the factors to consider when planning and executing these agreements. The template is meant to be used globally and has two parts, one for excipient manufacturers and one for distributors or suppliers. As with any agreement intended to be binding, IPEC recommends that advice of legal counsel be obtained by all parties. The guidance notes that "due to the increasing desire to have quality agreements in place with key suppliers, there has been a trend to use templates to get a large number of agreements in place quickly. Many companies, both users and suppliers, have developed their own templates to address quality agreements. Unfortunately, these individual templates have often been designed to cover multiple types of products (excipients, active pharmaceutical ingredients and/or packaging) and have been presented in an inflexible manner. The result of this has been extensive negotiations between companies, significant time and resources spent, and fewer agreements completed." Release of the guideline culminates IPEC's three-step approach to excipient qualification and supply chain control. As part of Phase 1, IPEC released a guideline in September 2007 that covered the steps a chemical manufacturer may make to evaluate the market and regulatory requirements for the proposed excipient and the steps leading up to market launch (1 (Also see "Excipient Qualification Process Set Forth in IPEC Guidelines" - Pink Sheet, 1 Oct, 2007.)). Phase 2, released in September 2008, covers excipient selection and overall qualification and follows the path a pharmaceutical company takes in evaluating the excipient for use in a formulation (see 2 (Also see "Proper Venue Sought for Resolving Global Pharma Supply Chain Crisis" - Pink Sheet, 1 Oct, 2008.)). Phase 3 governs the use of quality agreements in promoting a dialogue between excipient users and suppliers. The aim of all these guidelines is to improve communication and understanding between excipient makers and users. The templates, which are identical, have the following structure: The introduction, which includes the name of the parties to the agreement, the list of excipients covered by the agreement, the examples of potential quality criteria, the sites involved, and the use of third parties. Following the introduction is a checklist of who has responsibilities - either the supplier or the manufacturer - for the following activities: compliance; manufacturing, packaging and labeling; documentation and records; storage and distribution; change control; non-conformance; and auditing. - Joanne S. Eglovitch ([email protected]) |