What are the contents of the internal audit of the pharmaceutical factory quality system?The internal audit of the pharmaceutical factory quality system mainly includes the following aspects:
1. ** Organization Setting **: evaluate its rationality and ensure that the organizational structure can effectively support the operation of the quality management system.
2. ** Personnel related aspects **: Including personnel allocation, training, health management, etc., to ensure that the quality and health of personnel meet the requirements of drug production quality management.
3. ** Quality management system documents **: Review the effectiveness, adaptability, completeness, logicality, structure, maneuverability, and rationality of the documents to ensure that the provisions of the documents can be effectively implemented and help to achieve the quality objectives.
4. ** Management of facilities and equipment **: Review the configuration, effective operation, and verification management of facilities and equipment, including the temperature and humidity control system and the replacement of key facilities and equipment, to ensure that the equipment and facilities are in good condition and usable.
5. ** Computer System Management **: To ensure that the computer system management meets the quality management requirements and can accurately record and control the data related to drug production.
6. ** Drug production process management **: It covers the process management of drug purchasing, receiving, acceptance, storage, maintenance, sales, review, transportation, and after-sales service.
7. ** Records, certificates, files, and bills management **: Check the completeness, effectiveness, and preservation of various records, certificates, files, and bills.
8. ** Quality function and related site audit **: It mainly focuses on the quality function and related sites that affect the quality of drugs and service quality during the implementation of the Good Manufacturing Practice (GPS).
9. ** Special circumstances review **: For example, special internal review should be carried out after major changes in the key elements of the quality management system, such as changes in business methods and business scope, adjustments to the legal representative, the person in charge of the enterprise, the person in charge of quality, and the person in charge of the quality organization, changes in business sites, new construction, reconstruction (expansion), address change, temperature and humidity control system, and computer system changes; If a major quality accident occurs due to the quality of the drug and causes serious consequences, if there is a major problem with the service quality, or if there is a customer complaint or news exposure that causes adverse effects, a special internal review should also be conducted.
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Can you share some funny audit stories?Sure. One funny audit story is about an auditor who went to a small company. The company's 'file storage system' was just a bunch of boxes piled up in a corner. When the auditor asked for a specific document, the employees had to dig through the boxes for hours, and they ended up with papers all over the floor. It was chaos but also quite hilarious.
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2024-11-25 05:43