GMP--(Good Manufacturing Practice for Drug) refers to the responsible for the quality control of pharmaceutical production personnel and production operator's quality to the production workshop, facilities, buildings, equipment, storage, production process, quality management, technology and health, packing materials and labels, until the finished product storage and sale of a complete set of management system which is to ensure the quality of medicines.
The base of GMP is to ensure drug quality, must be to prevent the production of medicines mixed batch, mixed contamination and cross-contamination, in order to ensure the quality of the drug.
Basic content of GMP involves the personnel, plant, equipment, sanitary conditions, the starting materials, the production operation, the packing and label, quality control system, self-examination, sales records, user opinions and adverse reactions report, etc. To be met in terms of hardware environment, it needs to have plant and equipment; On software, it need to have reliable production technology, strict management system and perfecting validation system.
The GMP workshop requires to regard the technology as the leading factor, and completed the project with the help of other professions such as general layout, civil engineering, installation, electrical, hvac, close coordination with the outer tube and so on.
1.Production area should have enough plane and space, and need to have enough space put equipment and materials reasonablely, to prevent mixing among different drugs and cross contamination from other drugs or other substances.
- Storage of raw materials to be detected, semi finished products area.
- Intermediate laboratory area
- Equipment cleaning area
- Cleaning tool room area
- The processing of raw materials, processing area
- Stored pending unqualified raw materials, semi-finished products of the area, in order to avoid error operation.
2.Appropriate measures to ensure that there are different operating not in the same area at the same time;
3.Cleanliness level of interconnectedness between different rooms have antifouling measures;
4.In the layout should be compatible with the cleanliness level of purification facilities and rooms;
5.Raw materials, semi-finished and finished products and packaging materials storage area should be clear, to be seized products, qualified and unqualified products should have sufficient storage area and production areas to try to shorten the distance;
6.Full workshop flow, logistics should be simple, reasonable, to avoid flow, logistics confounding;
7.Different processes of production area best links at reasonable order process;
8.Should be wide enough aisle, to mark the junction to prevent mixing drug injection;
9.Should be sterile clothes washing (especially in the production or packing penicillins), drying room, and meet the requirements of the appropriate air cleaner;
10.Should have equipment and containers with washing area.
