Application of GMP standard pharmaceutical water in pharmaceutical enterprises

The World Health Organization began to organize the formulation of GMP in the mid-1960s It has been more than 20 years since GMP was issued in 1988 in China It is consistent with the GMP of who Through two revisions in 1992 and 1998, as of June 30, 2004, all APIs and preparations were produced in accordance with GMP Compared with the revised GMP in 1998, the length of the new version of GMP has increased greatly Based on the international experience, combined with China's national conditions, and in accordance with the principle of "equal emphasis on software and hardware", we should implement the concept of quality risk management and the whole process management of drug production, pay more attention to scientificity, and emphasize guidance and operability The code for quality management of drug production (revised in 2010) has been deliberated and approved by the Ministry of health's ministerial meeting on October 19, 2010, and is now released Since 2011 Effective as of March 1, 2002 It will further promote the production and quality level of the pharmaceutical industry Water is a basic raw material with large amount and wide use in pharmaceutical production Pharmaceutical water is the lifeline of pharmaceutical industry Therefore, GMP requirements for pharmaceutical water quality are relatively stricter and higher It is often required that the resistance of pharmaceutical water should be higher than 15 trillion to ensure the safety of pharmaceutical water GMP puts forward the quality standard of pharmaceutical water, and also puts forward the requirements for pharmaceutical water preparation device It is clearly pointed out that: 1 The structural design should be simple, reliable and easy to disassemble 2 In order to facilitate disassembly, replacement and cleaning of parts, standardized, universal and systematic parts shall be used as far as possible in the design of actuator 3 The internal and external surfaces of the equipment shall be smooth and flat without dead angle, easy to clean and sterilize The surface of parts shall be treated with chrome plating to prevent corrosion and rust Avoid paint on the outside of the equipment to prevent peeling 4 Low carbon stainless steel or other materials verified not to pollute water quality shall be used for the preparation of purified water equipment The equipment for preparing purified water shall be cleaned regularly and the cleaning effect shall be verified 5 The materials in contact with the water for injection must be high-quality low-carbon stainless steel (16L stainless steel) or other materials that are verified not to pollute the water quality The equipment for preparing water for injection shall be cleaned regularly and the cleaning effect shall be verified 6 The storage period of purified water should not be more than 24 hours, and its storage tank should be made of stainless steel or other materials that are verified to be non-toxic, corrosion-resistant and free of polluting ions A hydrophobic filter shall be installed to protect the vent of the filter The inner wall of the tank shall be smooth, and there shall be no dead angle and sand hole in the connecting pipe and weld Sensors showing parameters such as liquid level, temperature and pressure that will not form stagnant water pollution shall be used The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effect shall be verified 7 Purified water and pharmaceutical water should be delivered by stainless steel pump which is easy to disassemble, clean and disinfect In the case of purified water and injection water delivered by compressed air or nitrogen pressure, the compressed air and nitrogen shall be purified Purified water should be transported by circulating pipeline The pipeline design shall be simple and avoid blind pipe and dead angle Stainless steel pipes or other pipes verified to be non-toxic, corrosion-resistant and free of pollution ions shall be used The valve should be sanitary valve without dead angle, and the flow direction of purified water should be indicated The pipeline and pump for transporting purified water and injection water shall be cleaned, disinfected and sterilized regularly, and can be put into use only after passing the verification 8 The design of pressure vessels shall be undertaken by licensed units and qualified personnel, and shall be handled in accordance with the relevant provisions of the national standard of the people's Republic of China steel pressure vessels (gb150-80) and the "safety and Technical Supervision Regulations for pressure vessels" GMP standard also makes rigid requirements for the installation of pharmaceutical water preparation device, and the installation of equipment shall follow the following principles: when the installation of linkage line and double leaf sterilizer and other newer equipment may pass through two areas with different cleanliness levels, appropriate sealing method shall be adopted when the installation is fixed to ensure that the areas with high cleanliness level will not be affected If conveyor belt is used to transfer materials between rooms of different cleanliness levels, in order to prevent cross contamination, the conveyor belt should not pass through the partition wall, but should be transported in sections on both sides of the partition wall The delivery device to the sterile area must be delivered in sections Design or select light and dexterous conveying tools, such as conveyor belt, trolley, launder, soft connecting pipe, closed hopper, etc., to assist the connection between equipment For the installation of transmission machinery, shockproof and silencing devices shall be added to improve the operating environment During the dynamic test, the noise in the clean room shall not exceed 70dB The production equipment for the production, processing and packaging of penicillin and other highly sensitized drugs, some steroids, highly active and toxic drugs must be separately and exclusively used The new GMP standard is more rigorous and scientific This is also a new challenge for designers, not only to require that the design drawings meet the standards, but also to consider that the combination of the design drawings and pharmaceutical equipment is more perfect Strengthen the contact with the equipment manufacturers and listen to the opinions of the professionals of the equipment manufacturers, which will undoubtedly make the design drawings more reasonable.