Life Science Leader Magazine Supplements

CMO 2015

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QUALITY AGREEMENTS outsourcing By E. Miseta BEST PRACTICES FOR ESTABLISHING AND MANAGING A BALANCED QUALITY AGREEMENT LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 30 beyond the normal GMP considerations. That will generally depend on other exter- nal factors, such as the criticality of the service being provided and the geogra- phies in which the business will be exe- cuted. The right amount of balance, and setting these definitions right up front, will allow both sides to communicate more smoothly and effectively. AVOID THE LEGALESE AND THE CONTROL If there is one thing that can make the process of approving a quality agreement more complicated, it's using a template that is full of legal jargon. This can make the agreement very difficult to work through and will require quality person- nel to read through every sentence in an attempt to determine who's responsible for what. Anything that can be done to simplify the agreements will lead to bet- ter outcomes on both sides. For example, a couple of panelists remarked on the benefits of a simple tem- plate that is both easy to read and under- stand. One that has a list of responsi- bilities on the left and an X in a box under columns headed "CMO" and "sponsor" on the right often works well. That type of has a guidance regarding them. That would make many think that preparing a QA and putting it in place is a simple and straightforward process. Unfortunately, this is not always the case. In theory, the document is fairly straightforward. If the templates used by the vendor and the client are well aligned in terms of the requirements of both par- ties, that makes the process even easier. If, however, there are multiple templates being used by either party, or there are significant differences between them, the process can get much more com- plicated. There are also issues that can arise if provisions in the agreement can be interpreted differently by either party. One of the benefits of working with select partners on multiple projects is that both sides get to know each other better. After multiple iterations of the agreement with the same client, the pro- cess gets smoother each time. Having the FDA guidance makes the process even smoother. Still, there are considerations that need to be taken into account. One of the most important is ensuring the agreement contains an appropriate level of detail ith the FDA cracking down on the responsi- bilities of both parties in the relationship, it is more important than ever for both sides to be in agreement on the actions that need to be taken when a quality issue comes to light. A panel discussion at the Outsourced Pharma West Conference & Exhibition focused on these agree- ments, with representatives of both large- and small-sponsor companies sharing insights on the topic. The agreements are often born of a template that originates with one of the two parties. If anything became clear to me when listening to the exchange between panelists and audi- ence members, it was the importance of reviewing the document, under- standing it, and making modifica- tions when necessary. Here are some of the key takeaways from the session. PREPARING THE QA IS A STRAIGHTFORWARD PROCESS … OR IS IT? Quality agreements have been around for a long time, and now even the FDA Best Practices For Establishing And Maintaining A Balanced Quality Agreement One of the most important considerations when forging a CMO/client relationship is reaching a consensus on the wording of the quality agreement. W E D M I S E T A Executive Editor @OutsourcedPharm

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