1. Clean area
In the layout design of the gmp clean workshop of the pharmaceutical factory, to meet the corresponding cleanliness requirements, the general clean area can be divided into four levels:
Class A: It is a high-risk operation area. In the sterile assembly or connection operation area, it is necessary to use a one-way flow operation table to maintain the environmental state of the place. The one-way flow system wind speed control, only in a closed isolation operation area, or gloves In the box, lower wind speed can be used;
Class B: generally refers to the background area where the Class A clean area is located for high-risk operations such as aseptic preparation and filling.
Classes C and D: generally refer to the clean areas of less critical steps in the production of sterile drug products.
2. Production area
Aiming at the pollution problem of the gmp clean workshop of the pharmaceutical factory, it is necessary to carry out a formal and reasonable design and layout of the clean workshop according to the properties of the drug, the technological process and the cleanliness requirements.
1. According to the properties, process, use, production facilities and equipment of the drug, determine the workshop and make corresponding assessments;
2. For the production of special drugs, special or independent workshops, production facilities and equipment should be used, and reasonable purification treatment should be adopted for the exhaust gas, and attention should be paid to the exhaust vents, which should be kept away from the air inlets of other air purification systems;
3. The production of certain amide structure drugs or hormone products requires special facilities and equipment, and is strictly separated from other drug production areas;
4. In the production of cytotoxic and highly active chemicals, special facilities and equipment should be used. In special cases, protective measures should be taken and necessary verifications should be carried out. Such pharmaceutical preparations can be produced in stages and share the same production facilities and equipment;
5. The pharmaceutical gmp factory shall not be used for the production of non-medical products that have a bad influence on the quality of the medicines.
3. Storage area
1. The storage area of the pharmaceutical gmp factory shall have sufficient space to ensure the orderly storage of various materials and products such as raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products that are pending inspection, qualified, unqualified, returned or recalled.
2. The storage area should be able to meet the storage conditions of materials or products (such as temperature and humidity, avoid light) and the requirements for safe storage, and be inspected and monitored. Storage areas should be designed and constructed to ensure good storage conditions, with ventilation and lighting.
3. The layout and facilities of the receiving area of the pharmaceutical factory should be able to ensure the necessary cleaning of the outer packaging before the goods enter the storage area. Highly active materials or products and printed packaging materials should be stored in a safe area. Receiving, issuing and shipping areas should be able to protect materials and products from outside weather (eg rain, snow).
4. Pharmaceutical factories should usually have a separate material sampling area. The air cleanliness level of the sampling area should be consistent with the production requirements. If sampling in other areas or by other means, it should be possible to prevent contamination or cross-contamination.
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