This model master document of more than 35 pages for the manufacture of a quality technical contract clearly defines the obligations of the procuring entity and the contractor and is extremely beneficial for both parties. The proposal sets out all the provisions, agreements and controls necessary to avoid any misunderstanding that could lead to a product or work of unsatisfactory quality. This applies to knowledge of all medicines, including medicines subject to an approved application (e.g. B application for authorisation of a new medicinal product) and non-prescription medicinal products marketed as part of a non-prescription drug monograph. Owners holding an approved drug application should be aware of the application and marketing authorization requirements that may impact manufacturing activities. The two parties to a quality agreement should exchange relevant information to ensure compliance with CGMP and other applicable requirements of the FD &C Act. 2) Control of changes in manufacturing activities: an owner or contract establishment may modify processes, equipment, test methods, specifications and other contractual requirements. Both sides should discuss the changes and address the quality agreement. There are a few changes that owners should review and approve before they are implemented, and other changes that contractors can implement without notifying the owner. The manner in which all changes are managed should be specified in the agreement, including the assignment of responsibilities for the implementation of validation activities prior to the implementation of the changes, if necessary. In addition, both parties should be aware of the changes to be made to the FDA in a supplementary or annual report. The owner and the contracting entity should carefully consider and agree on the types of changes to report to each other and to the FDA, as well as the need to obtain approval from each party`s quality unit and the FDA, if applicable.
(7-8) (c) Materials management: the quality agreement should indicate which part defines specifications for components and which part defines processes for the audit, qualification and monitoring of component suppliers. It should also be determined which party is carrying out the necessary sampling and testing in accordance with the CGMP. This section of the quality agreement should address how the Parties ensure adequate inventory management, including labelling, label printing, inventory comparison and identification of product status (e.g. B quarantine). The agreement should specify how the contractual facility will avoid confusion and cross-contamination. The FDA does not expect the agreement to contain a full supply chain description for each component. However, the agreement should define responsibility for the physical control of materials at different points in the manufacturing process. For example, the quality agreement should cover liability for the conditions of storage, transport or shipment of materials. It should define the roles of each party in storage and transport – whether from the contractual establishment to the owner or to another contractual establishment for other operations.
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