Chartered Accountant Walkins

1. To establish the quality system
a. Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control
b. Keep current with good industry practices, and applicable to the mission of your operation.
2. To audit compliance to the quality system
a. Audit for compliance to policies and procedures: on paper vs. practice
b. Report on the performance of the quality system, including trends, that help
decision making for targeted actions
3. To establish procedures and specifications
a. Ensure that procedures and specifications are appropriate and followed
b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)
4. To establish manufacturing controls
a. Ensure that appropriate manufacturing in-process controls are implemented
b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory
5. To perform laboratory tests or examinations
a. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
b. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor
c. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
6. To review and approve or reject all things CGMP
a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
b. Review and approve/reject reprocessing and rework proced

Learn more...