Article XII of the biological products production environment air cleanliness level should be compatible with the product and production operations, plant and facilities should not cause contamination of raw materials, intermediates and finished products.
Article XIII of the production process involves the operation of high-risk factors, the air purification system and other facilities should also meet special requirements.
Article XIV of the biological products production operations should be carried out in compliance with the following table in the appropriate level of clean area, not listed operations can refer to the following table in the appropriate level of clean area:
Cleanliness level
Examples of production operations of biological products
Local A in the context of the B class
Appendix I Aseptic Drugs in the Central Africa Each process specified for final sterilized products
Pre-filling products without sterilization and filtration, their preparation, consolidation, etc.
Class C
Partitioning of positive sera, antigens and antibodies for in vitro immunodiagnostic reagents
Class D
Consolidation of raw plasma, separation of components, pasteurization prior to distribution
Oral preparations and their fermentation Cultivation of closed system environment (exposed parts need to be aseptic operation)
Enzyme-linked immunosorbent reagent and other in vitro immune reagents, liquid dispensing, dispensing, drying, internal packaging
Article XV In the production process of some specific live organisms in the stage of the use of the product should be based on product characteristics and equipment, to take the appropriate measures to prevent cross-contamination, such as the use of specialized plant and equipment, stage production methods, use of closed systems, etc.
Article 16 Inactivated vaccines (including genetically recombinant vaccines), toxoid and bacterial extracts and other products after inactivation, the same filling room and filling and freeze-drying facilities can be used alternatively. After each dispensing, adequate decontamination measures should be taken, and if necessary, should be sterilized and cleaned.
Article XVII of BCG vaccine and tuberculin production plant must be strictly separated from the production of other products plant, the production of live organisms involved in the production of equipment should be dedicated.
Article XVIII of pathogenic bacilli operation until the completion of the inactivation process should be the use of dedicated facilities. Bacillus anthracis, Clostridium botulinum and Clostridium tetani products shall be produced in the appropriate specialized facilities.
Article 19 Other types of bacillus products, in a facility or a set of facilities in the staged rotation of the production of bacillus products, at any time only one product can be produced.
Article 20 The use of closed systems for biological fermentation can be produced simultaneously in the same area, such as monoclonal antibodies and recombinant DNA products.
Article 21 The production and processing areas of sterile preparations should meet the cleanliness level requirements and maintain a relatively positive pressure; operation of microorganisms with pathogenic effects should be carried out in a special area and maintain a relatively negative pressure; the use of aseptic processes to deal with pathogens in a negative-pressure area or biological safety cabinets, the environment around them should be a relatively positive pressure of the clean area.
Article 22 of the bacterial (toxic) operation area should have an independent air purification system. Air from the pathogen operation area shall not be recycled; from the degree of danger for more than two types of pathogens operating area of the air should be discharged through the sterilization filter, the performance of the filter should be regularly checked.
Article 23 for the processing of living organisms used in the production of operating areas and equipment should be easy to clean and decontamination, cleaning and decontamination of the effectiveness of the validity should be verified.
Article 24 of the living organisms used for culture equipment should be able to prevent the culture of exogenous contamination.
Article 25 of the piping system, valves and respiratory filters should be easy to clean and sterilization. It is appropriate to use online cleaning, online sterilization system. Closed containers (such as fermenters) valves should be able to steam sterilization. Breathing filter should be hydrophobic material, and the use of validity should be verified.
Article 26 should be regularly confirmed that involves direct exposure of strains or products isolation, closed system without risk of leakage.
Article 27 of the production process contaminated by pathogens and equipment should be separated from the unused sterilized items and equipment, and have a clear sign.
Article 28 In the production process, if there is a need to weigh certain additives or ingredients (e.g., buffers), the production area may store a small amount of material.
Article 29 The cold storage and constant temperature room set up in the clean area shall take effective measures to isolate and prevent contamination to avoid contamination of the production area.
The above is the requirements in GMP Appendix 3, it depends on which category of in vitro reagent you have, there is generally no problem. However, it is better to
1. produce in the same room when the production of split time
2. different room production, and it is best to use different air-conditioning systems