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Collection What is cgmp authentication
CGMP certification refers to certification that meets current Good Manufacturing Practices (cGMP). CGMP is a series of production standards developed and implemented by the US Food and Drug Administration (FDA), aimed at ensuring the safety, quality, and reliability of drugs, food, and other products in the production process. Manufacturers can demonstrate by obtaining cGMP certification that they have developed and implemented relevant production processes, quality control plans, and documentation in accordance with regulatory requirements to ensure that the quality of their products meets international standards.
Obtaining cGMP certification is very important for drug and food manufacturers, as it is not only a necessary condition for obtaining market access, but also an important guarantee for ensuring product quality and safety. This certification is not only widely accepted and adopted in the United States, but also has become a basic requirement for compliance in many other countries and regions.
The content of cGMP certification audit includes the following aspects:
1. Personnel and organizational audits include personnel training and qualification requirements, organizational structure, and division of responsibilities.
2. The audit of equipment and facilities will evaluate the safety, effectiveness, and applicability of production equipment, as well as the hygiene conditions and environmental monitoring of production facilities.
3. The audit of raw materials and suppliers will evaluate the procurement channels, procurement, and reception processes of raw materials, including verifying the supplier's quality assurance measures.
4. Review and evaluate the identification, recording, and preservation process of samples to ensure their accuracy and completeness.
5. The audit of the production process will evaluate the product's process flow and operational steps, including inspection records, product transfer, and verification.
6. The audit of product quality will review product quality inspection and testing methods, including testing procedures and specifications for verifying product quality.
7. The review of document management will evaluate the process of preparing, reviewing, and approving quality management system documents, including the control of relevant documents and change management.
8. Review the reporting and investigation procedures for non compliant events, as well as the implementation of corrective and preventive measures.
9. Internal audit and management review: Evaluate the dynamics of the internal quality management system, including audits and evaluations of continuous improvement of processes and procedures.
10. Evaluate the retention time, backup, and archive management of files and records to ensure data traceability and integrity.
Overall, the cGMP certification audit covers personnel, equipment, raw materials, production operations, quality testing, document management, and other aspects of the production process to ensure product quality and compliance.
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