Quality Agreement Manufacturing

«The manufacture and analysis of orders must be properly defined, agreed and controlled to avoid misunderstandings that can lead to an unsatisfactory quality product or work. […] The contract must clearly state how the qualified person who releases any batch of product put up for sale assumes full responsibility» (extract from the rules on medicines in the European Union, Volume 4, good manufacturing practices, Chapter 7, manufacturing and order analysis). Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. A quality agreement is a comprehensive document that describes both the specific quality parameters of a project and the part responsible for executing those parameters. The degree of detail of a quality agreement will vary depending on the development phase of the project. Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides. The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. Sometimes a quality representative or legal counsel suggests that each document be prepared in such a way that it is alone and can be read and interpreted without reference to a second document. While this generally applies to a legal document, it is not the best approach in these circumstances. The new enforcement program has the effect of strengthening the responsibility of the owner companies that ordered CMOs in compliance with the CGMP rules by their CMOs.

As a result, CMOs may find that their clients are increasingly concerned about assessing the state of compliance in the CMO, including strengthening quality monitoring of proprietary businesses on CMO activities. The FDA continues to inspect CMOs in the same way as before. It is expected that the owner companies that have mandated the CMO will increasingly be subject to regulatory action due to violations of PMCs in their CMCs. Previously, it was rare for companies that owned the drugs and mandated CMOs to be cited for CGMP errors in their CMOs. As outlined in the FDA`s draft guidelines, the FDA considers the contractually agreed schedule to be the contract provider`s extension. This view is supported by Regulation CGMP 21 CFR 211.22 (a), which states that «the quality control unit is responsible for the authorisation or refusal of drugs manufactured, processed, packaged or contracted by another company» (2). The quality agreement must be developed and mutually accepted by the CMO and the customer prior to the acceptance of the supply contract, in order to ensure the identification of all invoiced items and any capacity restrictions. High cost pressures, increased competition, tight margins and inadequate quality systems have led, among other things, to a higher frequency of violations (p.B.

FDA-483s, alerts and import alerts) among CMOs. Most CMOs have several customers who enter into contracts with them, and it is not uncommon for owners with different expectations in terms of quality to be present. In addition, quality agreements have often only been discussed after supply contracts have been signed.