One of the unintended consequences of limiting the scope of the guidelines is that it allows CPPs to use them as a pretext to limit the sharing of quality responsibility to the commercial agenda. This certainly facilitates the work of the CDMO, as they have to juggle the differences between each client`s QMS. At a time when accelerated clinical plans are the norm rather than the exception, the need to maintain a practical distribution of quality responsibility during development is critical to a drug sponsor/owner`s ability to deliver a robust CMC and clinical program. Manufacturing quality agreements are complete written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party meets the CGMPs. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. Part -2 Link pharmastate.blog/2019/03/26/part-2-quality-agreements-what-is-it/ If you missed it above, the contract lab must generate complete data for all the work it does, as requested by GMP. This includes both the paper and electronic recordings I mentioned in a previous column entitled „Focusing on Quality“ (10).
Fda guidelines state that the quality agreement must document how the „immediate consultation“ requirement is met by either the owner or the contract laboratory (1). Both types of data must be protected and managed during the data retention period. As a general rule, there will be only two parties to a quality agreement; These are defined as the contract giver (i.e. the pharmaceutical company or sponsor) and the contractor (contract laboratory) in accordance with the EU GMP (2). The FDA also refers to „The Owner“ and the Contracted Facility (1). Whatever names are used, there are usually two parties participating in a quality agreement, unless you happen to be the Marx brothers (the party of the first part, the party of the second part… Part 10, etc.) (9).