One is to keep human error to a minimum. In management, the quality management department is required to be independent of the production management department. Establish a mutual supervision and inspection system.
The second is to prevent drug pollution and reduce quality. In terms of management, the standards and implementation of operating room cleaning and equipment cleaning provide strict health education for production personnel. Operators should have regular physical examinations to prevent production personnel from contaminating drugs with bacteria and viruses. Restrict non-production personnel from entering the workshop, etc. In terms of equipment, it is necessary to have corresponding mechanical equipment to prevent dust from polluting drugs. Specialization of operating room. Mechanical equipment, tools and containers in direct contact with drugs should be made of materials that will not change drugs, so as to prevent mechanical lubricating oil from polluting drugs.
The third is to ensure the quality management system of high-quality products. In terms of management, the quality management department independently exercises quality management responsibilities. Planned and reasonable quality control, under appropriate conditions, save the samples left by quality inspection after leaving the factory. In terms of equipment, the operating room and mechanical equipment should be reasonably equipped, using advanced equipment and reasonable process layout. In order to ensure the implementation of quality management, necessary experimental and inspection equipment and tools are equipped.
Guiding ideology: The quality forms of all drugs are produced, not simply tested.
Extended data:
The principle requirements for GMP certification enterprises to implement verification, and the specific requirements for process verification are as follows:
1, and the key processes should be verified beforehand or afterwards;
2. Before adopting a new process specification or a new preparation method, its applicability to conventional production should be verified; A production process using specified raw materials and equipment should be able to continuously and consistently produce products that meet quality requirements.
3, major changes in the production process must be verified;
Following the principle requirements of verification, enterprises can generally take the following items as their own standards.
1. A master plan for verification must be made and verification must be implemented as planned;
2. Having a complete verification document and getting approval is a prerequisite for the quality management department to decide whether the product is allowed to go on the market.
3. It must be established according to relevant laws and regulations and user requirements, and the standards should be quantified, and the verification results should be evaluated through the quantitative standards.
4. The verification scheme shall include the verification purpose, method and qualification standard, and shall be implemented after being approved by the Quality Management Department.
5. Systems, equipment, computers, processes, public works and instruments shall be confirmed according to the approved installation confirmation scheme.
6. Systems, equipment, computers, processes, utilities and instruments must be confirmed according to the approved operation confirmation scheme. Operation confirmation shall have the requirement of running time, and the results of operation confirmation shall be reviewed and approved by the Quality Management Department.
7. Systems, equipment, computers, processes, utilities and instruments must be confirmed according to the approved performance confirmation scheme. Performance confirmation should be carried out under the environmental conditions of daily production.
8. Except in special circumstances, the Quality Management Department has the right to make an exception. The batch number of product verification shall not be less than 3, and the products produced must meet the qualification standards specified in the verification plan. In addition, systems, equipment, computers, processes, utilities and instruments used for product verification must have corresponding verification documents.
9. Regular preventive maintenance, correction/verification and corresponding records are important conditions for verification. As-built drawings of workshops, facilities and various systems shall be updated accurately and timely.
10. The storage period of verification documents shall be specified. In addition to the storage period, the verification documents should also meet the requirements of safety, reliability and traceability.
1 1, systems, equipment, computers, processes, public works and instruments must have approved operating procedures, and personnel must be properly trained.
12. The systems, equipment, computers, processes, public works, instruments and related computers used for display, control or recording in contact with products shall be included in the clean verification scheme for verification.
13. The quantitative inspection methods of raw and auxiliary packaging materials, semi-finished products and finished products must be verified.
14. When the verified system needs to be changed, it must be carefully reviewed by the relevant personnel responsible for re-verification, and the traceable change review and approval documents related to the change should be filed.
15, key systems, equipment, computers, processes, public works and instruments should be monitored, checked/corrected or tested regularly to ensure that they are in a verified state.
References:
Baidu encyclopedia -GMP