GMP Workshop Planning
GMP refers to the quality of the personnel and operators in charge of the quality control of drug production, to the production plant, facilities, construction, equipment, storage, production process, quality control, process hygiene, packaging materials and labels, until the storage of finished products in the sale of a complete set of guarantee drug quality management system.
The basis of GMP is to ensure the quality of drugs, it is necessary to prevent mixed batch, mixed contamination and cross-contamination in order to ensure the quality of drugs.
GMP basic content involves personnel, plant, equipment, sanitary conditions, starting materials, production operations, packaging and labelling, quality control system, self-inspection, sales records, user feedback and adverse reports. In terms of hardware, there should be a consistent environment, plant, equipment; in terms of software, there should be a reliable production process, strict management system, improve the verification system.
GMP Workshop requires process-oriented, and in other professional such as general plan, civil engineering, equipment, installation, power, heating, pipe and other close cooperation to complete the process layout.
The production area should have sufficient plane and space, sufficient space for the proper placement of equipment materials, to prevent the intermingling of intermediates of different drugs and to prevent cross-contamination by other drugs or other substances
Measures are taken to ensure that different operations are not carried out in the same area at the same time
Inter-connected clean level between different rooms to have anti-pollution measures
In the layout should have the clean level suitable purification facilities and the room
Storage areas for raw materials, semi-finished products and finished products, and packaging materials should be visible. Sufficient areas should be kept separate and strictly separated for the goods to be inspected, the qualified products and the non-qualified products
The flow of people in the workshop, logistics should be simple, reasonable, to avoid confusion
The production area of different production process had better connect with each other in a reasonable order
With wide enough aisles and comprehensive marking to prevent mixing
Have Sterile clothing (especially the production or distribution of penicillin drugs) washing, drying room, and meet the corresponding air clean requirements
There is equipment and container washing area