Quality Agreement Purpose

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. According to the ICH guidelines, risk is defined as a combination of the probability of injury and the severity of the damage1. To manage risk, drug development and production depend on effective risk quality management (QM) – a systematic process of assessing, controlling, communicating and verifying patient risks and drug quality throughout the product lifecycle. The scope of a quality agreement may cover one or more of the following compliance activities: supply and distribution chain controls are also a matter of process performance and product quality assessment. These include rigorous testing of materials or consumables supplied by third parties and testing partners to ensure product quality and safety. Automated systems to monitor process performance and product quality promise real-time control and more frequent testing potential. 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. 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. I recommend that a supplier quality contract be put in place at the beginning of the development process.

Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. 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) Quality agreements assist both parties in conducting the overall review of the contract. They define, define and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to define its expectations and rules for projects and to ensure that the quality characteristics of both parties are coordinated and that each party receives effective quality services and products.


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