Pharmaceutical Technology Europe - October 2010 - (Page 11)

Developing a quality agreement template for single-use systems The development of quality agreements between biopharmaceutical companies and contract manufacturers is a critical activity to ensure that a product’s quality meets regulatory requirements. Such agreements are used to clearly establish each party’s responsibilities. Considering the increased reliance that single-use manufacturing technology places on suppliers to ensure biopharmaceutical quality, quality agreements have also begun to be established between single-use process equipment suppliers and users. While some companies have negotiated agreements on a case-by-case basis, there is a recognised need within the industry for a common Quality Agreement Template (QAT) specific to single-use manufacturing that highlights key performance criteria. With this in mind, the Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, has formed a Quality Agreement Template Task Force (QATTF) to develop such a template. changes to standard products, levels of disclosure and custom product quality specifications. The task group is currently defining a process for developing the document, which is expected to be completed over the next 4– 6 months. PTE Jerold Mar tin Why is a QAT needed? One of the major challenges with quality agreements that users and suppliers have experienced is that no two companies request the same information, resulting in many hours filling out and modifying each company’s unique forms. Based on a BPSA informal survey of single-use supplier QA managers, the BPSA estimates that 60–70% of the work undertaken to establish agreements between supplier and user is redundant. The BPSA QAT will be a consensus document that identifies commonalities of various templates and will be effective as a starting point for negotiations. At the moment, the BPSA QATTF is comparing existing templates and will be creating subsections that cover the key points. Some of the issues to be addressed will be identification of critical changes, change control and notification, subcomponent supplier qualification, component origin information, customer involvement in Based on a contribution by Jerold Martin, Senior Vice President, Global Scientific Affairs, Biopharmaceuticals at Pall Life Sciences and Chairman of the Board, Bio-Process Systems Alliance. To read the full version of this article, go to www.pharmtech.com/jmartin www.pall.com www.bpsalliance.org 1 CONTENTS 8 MATERIAL COMPATIBILITY 3 HARNESSING THE ADVANTAGES 10 SINGLE-USE BIOREACTORS 6 CMO ADOPTION 11 QUALITY AGREEMENT TEMPLATE 7 VALIDATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/jmartin http://www.pall.com http://www.bpsalliance.org

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2010

Table of Contents
Pharmaceutical Technology Europe - October 2010
Our Survey Says...
Harnessing the Advantages of Single-Use Systems
Should You Implement Single-Use Systems?
CMO Industry Adoption of Single-Use Technology
Validating Single-Use Systems
Material Compatibility and Single Use Systems
Achieving More Effective Cell Culture with Single-Use Systems
The Pros and Cons of Single-Use Bioreactors
Developing a Quality Agreement Template for Single-Use Systems
Ten Top Single-Use Technologies Showcased

Pharmaceutical Technology Europe - October 2010