Manufacturing quality agreements are comprehensive written agreements between parties involved in the manufacture of contracted medicines, which define each party`s manufacturing activities with respect to how each party will comply with the CMMs. The Fda guidelines continue (as part of case examples): “Regardless of the testing of products, the owners` quality units are ultimately responsible for ensuring that products are manufactured in compliance with CGMP. A quality agreement will not change that. FDA could cite the owners. because they do not evaluate, qualify, control and monitor their contractual establishments. A quality agreement should contain at least the following sections: The quality agreement must be designed and mutually accepted by the CMO and the customer prior to acceptance of the delivery agreement, in order to ensure the identification of all invoiced items and any performance limitations. A standard operating procedure should be put in place to indicate the types of suppliers and services for which a quality agreement is required. At least an agreement must be concluded for each use of a CMO and with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. A quality management approach (ICH Q9) to data integrity can be achieved by taking into account data risks and data criticism at each stage of the data lifecycle. The burden of control measures should be proportionate to that assessment of data risk and criticism.
Risk management should be applied throughout the life cycle. An initial risk assessment should be carried out to determine the GMP criticality of the system, i.e.: Does the system have an impact on patient safety, product quality or data integrity? Specifications are usually drawn up taking into account potential risks and form the basis of the first formal risk assessment. A recent example of a citation of a quality agreement in a warning letter (7) referred to a quality agreement concluded with the company`s contractual manufacturer, which did not contain provisions on the treatment of sterilisation and other provisions of the quality agreement that were not routinely complied with. While this warning letter refers to a device and follows the expectations of the purchasing controls at 21 CFR 820.50 (8), it also shows that clarity of roles and responsibilities and compliance with approved quality agreements are important aspects that must be taken into consideration when a company develops and implements a quality agreement with a contracting body. and can be evaluated while an FDA reviewer is on site. Data security measures should be at least equivalent to those applied in earlier phases of the data lifecycle. Subsequent changes to the data (e.g. .B. through an IT helpdesk or changes to the database), the pharmaceutical quality system should be monitored, with appropriate segregation of duties and authorisation procedures.
The criticality of the specifications recorded in the process may vary depending on the quality attribute being tested, the impact on subsequent manufacturing processes, and the ability to test the quality attribute in the finished product. It may therefore be possible to accept derogations from a process specification if the risk assessment confirms that there are no effects on the manufacturing process or on the quality of the product. Any disposal of data should be allowed under the quality system and carried out in accordance with a procedure ensuring compliance with the prescribed retention period. The FDA encourages parties involved in order manufacturing to implement quality management practices. This guide builds on the principles and recommendations of quality risk management set out in the ICH Guidelines to illustrate the most important points in the development and execution of quality agreements that describe and support contract manufacturing agreements. . . .