Written Quality Agreements With Outsourced Partners

Now, a new Rx-360 best practice guide has been released. Rx-360 is a non-profit organization dedicated to helping the pharmaceutical and biotechnology industries improve the security of the pharmaceutical supply chain. It is managed by members of the industry, including manufacturers and suppliers. Their supplier-led working group developed a best practice guide for quality agreements and published it on the Rx-360 website. The objective of this guide is to “support customers and suppliers in the effective management of the initiation, negotiation, implementation and continuous maintenance of quality agreements”. The aim is to enable a more efficient and effective negotiation process for quality agreements. Quality agreements are also set out in ICH quality documents. ICH Q7, 16.12, reads: “There should be a written and approved contract or formal agreement between a company and its contractors detailing each party`s GMP responsibilities, including quality measures.” Those who need to know the content of the quality agreement in order to do their job should be involved in the review of the agreement, including business development, project manager or case law (to ensure compliance with the supply agreement). One of the most overlooked sections in FDA guidelines is the definition section.

It is important for everyone to know what is meant by each term used in the quality agreement; especially in the case of contracts with parties of non-U.S. companies, the terminology can be very different. Add abbreviations and acronyms and define documents – one person`s batch record is another person`s data sheet. Define “subcontracting” and if and when it is acceptable. Below are some important points and suggestions that can help create a quality agreement that will become a valuable tool for your business, rather than just a document that meets regulators` expectations. In almost all cases of outsourcing of GMP activities, there will also be a commercial agreement on outsourced activities, such as.B. a “manufacturing and supply agreement”. This trade agreement is usually drafted by legal and business development staff and does not go into sufficient detail to meet GMP principles. The FDA`s current position on quality agreements is set out in the 2016 guidelines “Contract Manufacturing Agreements for Medicines: Quality Agreements.” The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement.

It highlights the seven most critical areas that should be addressed in a quality agreement and their specific impact in terms of quality control and change. It is important to understand the relationship between the quality agreement and the trade agreement. .

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