I. Personnel preparation
GMP certification needs the active participation and cooperation of various functional departments within the enterprise, so it is necessary to set up an organization to lead and coordinate this work, such as a GMP certification leading group and a GMP office, whose members should include the heads of various functional departments, who are respectively responsible for the transformation, rectification and improvement of hardware and software systems, which can be mainly divided into technical management, material management, quality management, plant equipment management and engineering management.
B, the preparation of funds
According to the requirements of GMP (Revised Edition 98), combined with the actual situation of enterprises, it is necessary to transform the hardware facilities such as factories and equipment, improve and revise the document systems such as production management and quality management, and train employees in GMP and skills, all of which require a certain amount of capital investment. Therefore, if an enterprise wants to carry out GMP certification, it will be managed by the leading organization of GMP certification and used exclusively. When using funds, we should try our best to invest the limited funds in the key projects of GMP certification to improve the efficiency of fund use.
C, self-inspection preparation
When enterprises formally implement GMP certification, they need to transform their hardware, modify and improve their software. Which hardware needs to be modified and which software needs to be modified and improved. We must know what hardware needs to be modified, how to modify it, which software needs to be formulated and which software needs to be improved. In other words, it is necessary to conduct self-inspection on the personnel, plant, equipment, documents, production, quality control, drug sales, user complaints and product recycling of the enterprise. Self-inspection should meet the following requirements: self-inspection should be carefully organized and cannot go through the motions; Self-inspection should be planned, GMP (Revision 98) and certification inspection evaluation standards should be checked item by item, and the defects found should be recorded and analyzed frequently; The scope of self-inspection work should be clear and carried out step by step; Various forms of self-examination can be adopted, such as internal self-examination of departments and mutual inspection of relevant departments. Invite advanced enterprises and GMP certification enterprises to assist in inspection and guidance.
D, GMP certification project preparation
The key items in GMP certification inspection and evaluation standards should all meet the requirements. On the basis that the hardware meets the requirements, do a good job of modifying and perfecting the documents. Because the enterprise's file system reflects the production management, quality management and regulatory level of the enterprise, and also reflects the GMP implementation level of the enterprise. According to the contents of the inspection items, the following aspects are mainly inspected: 1. All workshops, warehouses and posts should have written and approved SOPs or standards, which are valid versions and can be consulted by employees at any time. 2. There are management systems and relevant regulations for the acceptance, sampling, inspection, warehousing and distribution of raw and auxiliary materials and packaging materials, and there are implementation records and traceability.
3. Warehousing: The division of functions is clear, including receiving goods, waiting for inspection, sampling, nonconforming products, qualified products, returning to warehouse, etc. The status identification is clear, the goods, cards and accounts are consistent, and the unqualified products are stored in special areas, with ventilation, insect prevention and rat prevention measures. Labels and instructions for use should be managed by a special person and stored in the counter, and important items, valuables and dangerous goods should be stored in the counter.
4. The sampling room for raw and auxiliary materials and packaging materials in direct contact with drugs should be set at the height of the storage area. If there is no sampling room, measures should be taken to prevent pollution and cross-contamination.
5. The storage area should be clearly planned, and the appropriate temperature and humidity should be controlled.
6. The status identification of all field equipment, instruments and tools should be clear.
7. The production status identification of each room in the workshop and the cleaning status identification of all equipment, instruments and tools should be clear.
8. For the training of enterprise employees, including GMP knowledge, process flow, operating procedures or SOP, there should be written training plans, training programs, training records and assessment results, and employee training files should be compiled.
9. Enterprises should formulate GMP self-inspection procedures, formulate enterprise self-inspection plans and strictly implement them.
10. There are cleaning and maintenance procedures for workshops, facilities, equipment, containers and tools, and complete implementation records. 1 1. Work clothes in different clean areas should have different requirements and cannot be mixed. The cleaning method, cleaning cycle, sterilization storage and replacement time of work clothes shall be specified in writing and recorded.
12. The health records of production personnel should be complete, with records of regular physical examination.
13. The customer complaint handling procedures and the product recall system with quality as the goal should always be decided by the market. There should be a special person responsible for handling customer complaints.
14. A product sample retention system shall be established and a complete sample retention record shall be kept.
15. There should be verification documents of air conditioning purification system and records of regular inspection, cleaning and replacement.
16. There should be verification documents and complete records of process water and water quality monitoring system.
17. Key working procedures and major equipment shall have verification documents. If the production process changes, it should be verified and a verification document should be formed. 18. Spot check the batch production records (including customs clearance records), batch packaging records and batch inspection records of the whole process of raw materials entering the factory and finished products leaving the factory.
In a word, an enterprise can formally apply for GMP certification only after it has fully completed the preparatory work before declaration, formed a document through self-examination and rectification, and considered that its GMP management has met the requirements of GMP.