Technical Agreement Gmp

A typical technical agreement should include the following elements: the agreement should clearly define the cases of routine, escalation and emergency and how it is to be managed. The agreement should also define what happens in the event of a dispute that may be raised by one of the parties and should document the mechanism for the prompt and effective resolution of disputes. The scope of the quality agreement should encompass several compliance activities, such as.B. the qualification, calibration and maintenance of analytical equipment and means of manufacture; validation of computer systems, analytical methods and manufacturing processes; the specifications used to pass or not pass analytical tests; handling, storage and processing of supply; receipt, analysis and notification of samples; collection and management of laboratory records; and deviation management and change control. In the eyes of the FDA, any activity that is not documented cannot have taken place either. A quality agreement offers the contractual entity and the owner the opportunity to define the expectations that verify and approve quality documents. It shall describe the minutes of changes to standard operating procedures (SIRs), manufacturing records, specifications, validation documentation and other essential documents relating to the goods or services provided by the contracting entity. The role of both parties in the production and maintenance of original DOCUMENTS in accordance with the PMFR or original copies should be clarified. The agreement should also specify how these recordings will be made available for consultation. It is beneficial to add a statement that electronic records are retained in accordance with CGMP and kept in an accessible state during the necessary registration windows defined by the applicable rules in accordance with FDA requirements. . . .

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