GMP(Good Manufacturing Practice) is a common quality management system in pharmaceutical industry, which aims to ensure that the production process of drugs meets the prescribed quality standards. GMP compliance inspection is a process to evaluate whether pharmaceutical enterprises meet GMP standards. The following are some common contents of GMP compliance inspection:
1. facilities and equipment: check whether the production facilities and equipment of the enterprise meet GMP standards. This includes proper building structure, proper technological process and equipment maintenance plan.
2. Staff training: Evaluate whether the enterprise has provided sufficient staff training to ensure that they understand and abide by GMP standards. Training can include hygiene and cleaning operations, cross-contamination control of drugs and good record keeping.
3. Document management: check the enterprise's document management system, including SOP (standard operating procedures), medicine calendar, quality documents, etc. These documents should be correctly compiled, approved and managed to ensure the traceability and accuracy of the production process.
4. Raw material procurement and control: evaluate the procurement, inspection and control process of raw materials. This includes ensuring the qualification of raw material suppliers, procurement procedures, raw material inspection and acceptance standards, etc.
5. Production process control: check whether the production process of the enterprise can ensure the consistency and quality of products. This includes proper operational control, process verification, production records and product traceability.
6. Quality control: evaluate the quality control laboratory of the enterprise to ensure that its equipment, methods and personnel meet the requirements. This includes testing and verifying product quality, sample management and reporting results.
7. Change control: Check the change management procedures of the enterprise to ensure that all changes have been properly evaluated and approved. This includes equipment replacement, process improvement and specification revision.
8. Disposal of nonconforming products: evaluate the disposal procedures of the enterprise for nonconforming products, including the ability to review, investigate and dispose of nonconforming products.
9. Internal audit: check whether the enterprise conducts internal quality audit regularly, and take appropriate corrective and preventive measures for the problems found.
10. Adverse event reporting and tracking: Evaluate the adverse event reporting and tracking procedures of enterprises to ensure that any quality problems can be found, investigated and corrected in time.
The above are just some common contents of GMP compliance inspection, and different countries and regions may have specific requirements and standards. Enterprises should carry out GMP compliance inspection according to local regulations and industry standards, and constantly improve their own quality management system to ensure product quality and safety.