PTE: Do regulators want to see copies of quality agreements when conducting inspections? As mentioned in the FDA`s current guidelines on quality agreements (1), “if all parties clearly understand their GMP-related manufacturing roles and responsibilities, owners who use contract facilities, contractual facilities that provide services to owners, and ultimately patients taking drugs manufactured under these agreements can benefit in several ways. each party involved in the manufacture of a medicinal product is responsible for GMP compliance for its manufacturing activities. This shows how important it is to conclude a strong quality agreement and to clearly define the roles and responsibilities of the company and the contractual institution. Audits are a key mechanism to create assurance that the contact laboratory meets the requirements of the quality agreement or contract. If non-conformities are detected, they can be remedied before any regulatory inspection. In almost all cases of outsourcing of GMP activities, there will also be a commercial agreement on outsourced activities, such as.B. a “manufacturing and supply agreement”. This trade agreement is usually drafted by legal and business development staff and does not go into sufficient detail to meet GMP principles. In the eyes of the FDA, any activity that is not documented may just as well not have occurred. A quality agreement gives the contractual facility and the owner the opportunity to set expectations as to who reviews and approves quality documents.
It shall describe protocols for modifying standard operating procedures (SOPs), manufacturing records, specifications, validation documentation and other essential documents related to the goods or services provided by the procuring entity. The role of both parties in creating and updating original documents or original GMP copies should be clarified. The agreement should also specify how these records are to be made available for inspection. It is beneficial to include a statement that electronic records are stored in accordance with GMP and kept in a recoverable state during the required registration windows specified in applicable regulations in accordance with FDA requirements. An unintended consequence of restricting the scope of the guidelines is that CDMOs can use them as a pretext to limit the division of quality tasks down to the trade program. .