Betekenis Master Agreement

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. . . .