The design specifications for pharmaceutical factories are the same, but
Vaccines are biological products. Please refer to Appendix 3 of the GMP specification for instructions on biological products.
Chapter 4 Plants and Equipment
Article 12 The air cleanliness level of the biological product production environment should be suitable for the products and production operations. Plants and facilities should not be used for raw materials, intermediate Contamination of the body and finished product.
Article 13 For operations involving high-risk factors in the production process, the air purification system and other facilities should also meet special requirements.
Article 14 The production operations of biological products should be carried out in clean areas that comply with the corresponding levels specified in the following table. Operations not listed can be carried out in clean areas of appropriate levels with reference to the following table:
Cleanliness level Examples of biological product production operations
Partial level A in the context of level B Appendix 1 Processes specified for non-terminal sterilized products in sterile drugs
Preparation, combination, etc. of products that are not sterilized and filtered before filling
Level C: Packaging of positive serum, antigens and antibodies of in vitro immunodiagnostic reagents
Level D: Combination of raw plasma, separation of components, and pasteurization before packaging
Fermentation and culture of oral preparations in a closed system environment (the exposed parts require aseptic operation)
Enzyme linkage Preparation, packaging, drying and inner packaging of in vitro immune reagents such as immunoadsorption reagents
Article 15 The stage of using certain specific living organisms in the production process shall be based on product characteristics and equipment conditions. , take corresponding measures to prevent cross-contamination, such as using dedicated workshops and equipment, staged production methods, using closed systems, etc.
Article 16 After inactivation of inactivated vaccines (including genetically recombinant vaccines), toxoids, bacterial extracts and other products, the same filling room and filling and freeze-drying facilities can be used alternately. After each repackaging, adequate decontamination measures should be taken, and sterilization and cleaning should be carried out if necessary.
Article 17 BCG and tuberculin production plants must be strictly separated from other product production plants, and production equipment involving living organisms in production must be dedicated.
Article 18 Special facilities should be used for handling pathogenic spore bacteria until the inactivation process is completed. Bacillus anthracis, Clostridium botulinum and Clostridium tetanus products must be produced in corresponding dedicated facilities.
Article 19: For other types of Bacillus products, when the production of Bacillus products is rotated in stages in a certain facility or a set of facilities, only one product can be produced at any time.
Article 20 Biological fermentation using a closed system can be produced simultaneously in the same area, such as monoclonal antibodies and recombinant DNA products.
Article 21 The production and processing area of ??sterile preparations should meet the requirements of cleanliness level and maintain a relatively positive pressure; handling of pathogenic microorganisms should be carried out in a dedicated area and maintained at a relatively negative pressure. Pressure; the surrounding environment of negative pressure areas or biological safety cabinets that use aseptic processes to treat pathogens should be a clean area with relatively positive pressure.
Article 22 The bacterial (toxic) operating area should have an independent air purification system. The air from the pathogen operating area shall not be recycled; the air from the pathogen operating area with risk level II or above shall be discharged through a sterilizing filter, and the performance of the filter shall be checked regularly.
Article 23 Production operating areas and equipment used for processing living organisms should be easy to clean and decontaminate, and the effectiveness of cleaning and decontamination should be verified.
Article 24 Equipment used for the cultivation of living organisms shall be able to prevent the culture from being contaminated by external sources.
Article 25 Pipe systems, valves and breathing filters should be easy to clean and sterilize. Online cleaning and online sterilization systems should be used. Valves of closed vessels (e.g. fermenters) should be steam sterilizable. Breathing filters should be made of hydrophobic material, and their validity period should be verified.
Article 26 It should be regularly confirmed that there is no risk of leakage in isolation and closed systems involving direct exposure of bacterial strains or products.
Article 27: Items and equipment contaminated by pathogens during the production process should be separated from unused sterilization items and equipment, and clearly marked.
Article 28 During the production process, if certain additives or ingredients (such as buffers) need to be weighed, a small amount of materials can be stored in the production area.
Article 29 For cold storage and constant temperature rooms set up in clean areas, effective isolation and pollution prevention measures should be taken to avoid contamination of the production area.