Agreement Is Quality

A quality agreement should indicate which party will define component specifications and which part will define processes for auditing, qualifying and monitoring component suppliers. It should also be determined who carries out any tests or sampling necessary to comply with the CGMP. We will continue our analysis of the new guidelines in Part 2 of this article in two parts and examine what it offers at all stages in terms of change control, product-specific thinking, laboratory control, documentation, quality and compliance. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, each tailored to the relevant aspects of each type of relationship. In addition, the European GMP Directives provide that „the contract should clearly describe who carries out each stage of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and procurement of materials, verification and release of materials, performance of production and quality controls (including process controls, sampling and analysis). Conversely, a delivery contract describes how the supplier promises to deliver all the goods or services indicated over a specified period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The supply agreement facilitates the management of cooperation between companies, removes ambiguities and provides the framework for how goods and services are ordered and delivered.

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