Quality assurance with input from manufacturing and laboratory personnel from both parties should prepare the agreement. The quality assurance functions 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. One of the many important details of quality agreements is the time windows. If a CMO wants a processing time of five days to verify a record master batch (MBR), this can be useful because there is no need to verify the data. However, if the CMO wants five days to review a batch production record (OPI) executed, this is not appropriate in most cases. There is simply too much data that needs to be verified to be able to do a thorough job in five days. The quality agreement must be drafted and mutually accepted by the CMO/contractor and the customer prior to the supply contract in order to ensure the identification of all elements of fee-for-service and any capacity limitations. Neither side should take anything for granted.
One of the most overlooked sections in the FDA`s guidelines on #quality agreements is the definition section. It is important to know what is meant by each term, especially in contracts with parties of non-US suppliers, it is said @MCMasterControl bit.ly/2DwrlEC a formal corporate policy document should clearly state the types of suppliers and services that require a quality agreement. Whenever a CMO/contractor is used, a quality agreement must be concluded. A quality agreement should exist with all suppliers of critical materials and is also recommended for suppliers of large quantities, para. B example methylcellulose for capsules, column resins, etc. In today`s environment of virtual businesses and outsourced drug development, it is important to properly supervise and monitor regulators. With the publication of ICH/GCP Addendum E-6 (R2) 2016, proponents must also demonstrate adequate monitoring of CROs by suppliers, including those awarded by the ORC-SPONSORS to another party. A quality agreement is the ideal tool to define responsibilities and expectations. A quality agreement in the context of pharmaceutical development is an agreement that is mutually negotiated and concluded between the quality departments of a sponsor (pharmaceutical companies) and their suppliers (CRO, etc.). It is intended to define responsibilities with regard to quality tasks and to help ensure the development of safe products. Contractual partnerships inevitably have problems and quality agreements ensure that they are dealt with quickly and systematically. The above points belong to the supply contract.
The quality agreement should be a separate document from the supply contract, but may be incorporated by reference. Quality agreements and supply agreements are two very different documents. When created as a single document, the list of reviewers includes many people on either side of the fence who have no real reason or time to consider issues that have nothing to do with their area of expertise. The ICH Guidelines for the Industry Pharmaceutical Quality System Q10 recommend that, as part of a pharmaceutical grade system, the owner is ultimately responsible for ensuring that „processes are in place to ensure the control of outsourced activities and the quality of materials purchased.“ It shows that these processes should integrate quality risk management and include core activities, such as: There is a misconception that quality agreements are only required for the use of collective management organisations operating in a different regulatory environment. This is not the case – any outsourcing contract should have an associated quality agreement, including agreements between different departments of the same company, regardless of the physical location of one of the parties involved. Whenever an entrepreneur or marketing director is deployed, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement must be concluded. The agreement should cover all aspects of the project that affect the identity, quality, safety, efficacy and purity of a product. .
