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GB 28670-2012 English PDF

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GB 28670-2012: General rule of pharmaceutical machinery conforming to good manufacturing practice
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Standard similar to GB 28670-2012

GB/T 36030   JB/T 20032   GB/T 15692   GB/T 42354   GB/T 28671   

Basic data

Standard ID GB 28670-2012 (GB28670-2012)
Description (Translated English) General rule of pharmaceutical machinery conforming to good manufacturing practice
Sector / Industry National Standard
Classification of Chinese Standard C90
Classification of International Standard 11.120
Word Count Estimation 12,196
Quoted Standard GB 150.1-2011; GB 151-1999; GB 3836.1-2010; GB/T 4272-2008; GB 5226.1; GB 5959.6-2008; GB/T 9969; GB 12158-2006; GB/T 15692-2008; GB 17914-1999; GB 17916-1999; GB/T 28671-2012; GB 50231-2009; HG 20660-2000; TSG D0001-2009; TSG R0004-2009; pharmaceutical p
Regulation (derived from) National Standards Bulletin No. 24 of 2012
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This Chinese standard specifies the pharmaceutical machinery (equipment) the implementation of"Good Manufacturing Practice"General requirements. Also for pharmaceutical machinery (equipment) product quality control and management of the basic requirements

GB 28670-2012: General rule of pharmaceutical machinery conforming to good manufacturing practice


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General rule of pharmaceutical machinery conforming to good manufacturing practice ICS 11.120 C90 National Standards of People's Republic of China Pharmaceutical Machinery (apparatus) Embodiment Good Manufacturing Practices of General Published 2012-09-03 2013-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued

Foreword

Chapter 4 of this standard 4.1 to 4.4 are recommended, the rest are mandatory. This standard according to "Good Manufacturing Practice (revised 2010)," the relevant requirements and GB/T 1.1-2009 given rules Drafted. This standard is proposed and managed by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356). This standard drafting units. China Pharmaceutical Equipment Industry Association, Chongqing Branch Xu Pharmaceutical Machinery Equipment Manufacturing Co., Ltd., Chinese medicine Group Chongqing Medical Institute. Participated in the drafting of this standard. Shanghai Far East Pharmaceutical Machinery Co., Ltd., Shanghai Pharmaceutical Machinery Co., Ltd. Taiwan Intertek health. The main drafters. Zheng Guozhen, Wu Xia, Shi Qing, Sun Jinlian, high cloud-dimensional, real Chen Lu, Dong Chunliang. Pharmaceutical Machinery (apparatus) Embodiment Good Manufacturing Practices of General

1 Scope

This standard specifies Pharmaceutical Machinery (equipment) with the general requirements of "Good Manufacturing Practice" of. It is also a pharmaceutical machinery (equipment) The basic requirements of product quality control and management. This standard applies to pharmaceutical machinery (equipment) in product design, manufacturing, testing, installation, operation, maintenance and verification.

2 Normative references

The following documents for the application of this document is essential. For dated references, only applies to the version dated paper Pieces. For undated references, the latest edition (including any amendments) applies to this document. GB 150.1-2011 pressure vessel Part 1. General Requirements GB 151-1999 shell and tube heat exchanger GB 3836.1-2010 explosive atmospheres - Part 1. General requirements Device GB/T 4272-2008 General equipment and piping insulation technology GB 5226.1 Electrical safety of machinery Electrical machinery equipment Part 1. General requirements GB 5959.6-2008 Safety Part heating means 6. safety regulations industrial microwave heating apparatus GB/T 9969 General Industrial Product Manual GB 12158-2006 General Guidelines to prevent static electricity accident GB/T 15692-2008 pharmaceutical machinery term GB 17914-1999 flammable and explosive goods storage and preservation GB 17916-1999 toxic goods storage and preservation GB/T 28671-2012 Pharmaceutical Machinery (equipment) Verification Guidelines GB 50231-2009 mechanical equipment installation construction and acceptance of universal norms Toxic hazards and degree of chemical hazard classification HG20660-2000 media explosion pressure vessel TSGD0001-2009 Pressure Pipeline Safety Supervision Regulations (the State Administration of Quality Supervision, Inspection and Quarantine No. 44 of 2009 announcement) TSGR0004-2009 State Administration of Fixed Pressure Vessel Safety Technical Supervision Regulation (Quality Supervision, Inspection and Quarantine in 2009 Announcement No. 83) Good Manufacturing Practice (revised 2010) (People's Republic of China Ministry of Health Decree of 79 January 2011) People's Republic of China Pharmacopoeia (2010 edition) (National Pharmacopoeia Commission)

3 Terms and Definitions

GB/T 15692-2008 and defining the following terms and definitions apply to this document. 3.1 Dust dust It can be suspended in the air for a long time the suspended solids. 3.2 Isolator operator isolator It always refers to an internal environment from the external environment with Class B (ISO 5 level) or higher purity levels of the air cleaning device, and (e.g. It apparatus or system in a clean room and the operator) is completely isolated. 3.3 Intervention limited isolation barrier system (RABS) restrictedaccessbarriersystem Forming an isolation barrier between the drug and production operators, providing a "door" type operation or allows very little dielectric loading type Into its internal environment is a class A, the background environment of class B, aseptic unit interposed between the clean rooms and isolators. 3.4 Non-ionizing radiation non-ionizingradiation Wavelength > 100nm electromagnetic radiation sufficient to cause ionization of the organism. It comprises a high frequency electromagnetic field, microwave radiation, laser radiation, ultraviolet radiation Fire and so on.

4 General

4.1 General Requirements Pharmaceutical Machinery (equipment) in the design, manufacture, testing, installation, operation, maintenance and verification should meet pharmaceutical production processes and the corresponding "drug Health Requirements production quality management practices "(revised 2010), in line with the intended use. Should minimize contamination during pharmaceutical production, Cross-contamination, such as the risk of confusion and error. It should be easy operation, maintenance, disinfection or sterilization and for cleaning necessary. 4.2 Quality Management System Pharmaceutical Machinery (equipment) designs, manufactures organization shall establish a quality control system. 4.3 Training The organization shall carry out their duties and Pharmaceutical Machinery (equipment) design, production and personnel involved in quality management, standards, skills, etc. Training. 4.4 Product Quality Evaluation Product quality evaluation should be implemented, complete all the required inspection, testing, validation, parameter compliance, approved release. 4.5 Design and Manufacturing 4.5.1 Principles 4.5.1.1 Pharmaceutical Machinery (equipment) designed prior to manufacturing, the main material should confirm its primary function, technical performance parameters, and in contact with the medium Structure, cleaning and disinfection (sterilization) way, control and maneuverability, and its impact on drug production environment should be consistent with "drug Good Manufacturing Practice "(2010 revision), user needs and requirements of the corresponding product standards. 4.5.1.2 Pharmaceutical Machinery (equipment) should be energy saving, environmental protection, safe, reliable, and easy operation and maintenance, ease of cleaning, disinfection or sterilization. 4.5.1.3 Pharmaceutical Machinery (equipment) automatic control and intelligent monitoring levels should meet the needs of the development of pharmaceutical production. Use of electronic data Processing system Pharmaceutical Machinery (equipment) should be used in passwords or other means to control sign-on system, data input, change and delete data, and There are records. 4.5.2 The main material 4.5.2.1 Pharmaceutical Machinery material (equipment) or with drugs required process medium should be in direct contact with non-toxic, corrosion resistant, do not fall off, does not Drugs or process media required chemical reaction, adsorption, or release of the substance to the drug. Need disinfection and sterilization components material should High temperature steam or chemical sterilization gas. 4.5.2.2 Pharmaceutical Machinery (equipment) filter used should not shed fibers, asbestos, not react with the product, or the release of substances adsorbed substance. Insulating material particles must not fall off, not pollute the environment and drugs. Materials 4.5.2.3 pressure apparatus main pressure elements should meet the requirements and other mandatory GB 150-2011 standard. 4.5.3 surface quality 4.5.3.1 Pharmaceutical Machinery (equipment) appearance surface (a surface including insulation) should be smooth, flat, no cleaning blind, without falling particles. Allowing the surface coating of the coated layer should be dense, must fall off. 4.5.3.2 Pharmaceutical surface mechanical (equipment) in direct contact with the material should be smooth, flat, non-blind cleaning, all corners smooth transition, facilitates Cleaning, disinfection or sterilization. 4.5.4 Structure 4.5.4.1 Pharmaceutical Machinery lubricant (device) can not be used to contaminate the drug. It should be used as food grade level or equivalent Lubricant. Heating part of the unit, liquid (or drug) delivery conduit, and drug packaging parts in contact with the mold cavity shall be provided Lubricant fill institutions. 4.5.4.2 Pharmaceutical mechanical cleaning (device) used, disinfectant, heating, cooling medium can not contaminate the products produced. 4.5.4.3 Pharmaceutical Machinery (device) used in water, gas (steam) or the like with the process medium should cleanliness requirements of pharmaceutical technology adapted purification Filter means, adjusting means, and sampling. It should be able to filter integrity testing. For drying and sterilizing gases should final filter Placed after the heat exchanger. 4.5.4.4 Pharmaceutical Machinery (equipment) should prevent reverse flow of air exhaust means. 4.5.4.5 Pharmaceutical Machinery (apparatus) system should be easy to clean, portions in direct contact with the material to be achieved as clean in place, in place sterilization. 4.5.4.6 Pharmaceutical Machinery (equipment) should be set to the parameters of the test point and the necessary verification of preformed holes or sampling port. Pharmaceutical Machinery (equipment) dust trapping device should be generated dust 4.5.4.7, dust explosion risk of dust explosion-proof means should have and In addition to static guide means. Production of highly sensitizing drug device, the exhaust gas should be discharged through the high efficiency filter. 4.5.4.8 cooling and cryogenic equipment and piping insulation surface should meet the GB/T 4272-2008 predetermined easy to add heat insulating layer Isolating means should be provided. 4.5.4.9 Pharmaceutical Machinery (equipment) should run smoothly. Active vibration isolation equipment should storm means of the transmission mechanism and the vibration of the moving member Exposed parts of the safety devices should, transmission means should be sealed, to prevent particles from lubricating oil, foreign matters and friction into the medicament. Generating non-ionizing radiation 4.5.4.10 Pharmaceutical Machinery (apparatus) apparatus, should shielding, grounding, absorption means. 4.5.4.11 transmission equipment accommodating container material should be stamped and identification. 4.5.4.12 installed in the clean room Pharmaceutical Machinery (equipment), in addition to special requirements, no anchor bolts. 4.5.4.13 Pharmaceutical Machinery (equipment) require frequent replacement, adjustment, detachable parts, which should be easy to operate, and reliable. And between the auxiliary equipment Should be quick connection structure, disassembly should be simple and reliable. 4.5.4.14 across different levels of the clean area Pharmaceutical Machinery (equipment) should be sealed off or leaving the sealing means blocking position. 4.5.4.15 pharmaceutical machinery equipped on (device) weighing, measuring tools, instruments and meters range and accuracy should be in line with the production and quality control Seek, weighing, measuring tools, test equipment and instrumentation should have the qualification test unit marks and expiration date. 4.5.4.16 Pharmaceutical Machinery (equipment) should have overload protection, control chains, mechanical fault alarm protection structure and electrical control means. 4.5.5 Security 4.5.5.1 Pharmaceutical Machinery (apparatus) relates to the pressure vessel and pressure piping, shall GB 150-2011, GB 151-1999 and TSGR0004-2009, provisions TSGD0001-2009 the design, manufacture, inspection and acceptance. Design and manufacture shall have a corresponding Qualifications, products were technical documents should be complete. 4.5.5.2 Use explosion of dangerous chemicals Pharmaceutical Machinery (equipment) should be required to determine the level of explosion in HG20660-2000. Explosion venting device which should meet the requirements GB 150.1-2011 Appendix B of the overpressure relief device; Electrical equipment should meet GB 3836.1-2010 The relevant provisions; guide means in addition to the electrostatic grounding should conform in GB 12158-2006; and should the hazard warning device. 4.5.5.3 storage or use of flammable, explosive, toxic media vent pipe should lead to the outdoor equipment, and should be set to meet GB 17914-1999 And appropriate protective equipment specified in GB 17916-1999. Safety performance 4.5.5.4 microwave heating devices and microwave radiation limits should be consistent with the provisions of GB 5959.6-2008. 4.5.5.5 transportation of flammable, explosive medium pipe guide should have static electricity removing devices. 4.5.5.6 insulation surface average temperature not higher than 40 ℃, the maximum instantaneous temperature no higher than 60 deg.] C; minimum temperature of not lower than 5 ℃ Provisions. 4.5.5.7 electrical safety performance should be consistent with the relevant provisions of GB 5226.1 and other mandatory standards. 4.5.6 Noise Pharmaceutical Machinery (equipment) shall comply with national noise standards or industry-related products. 4.6 Installation 4.6.1 Pharmaceutical Machinery (equipment) products factory documents should be complete, intact. Written using instructions should be consistent with GB/T 9969 requirements, should The product can meet the installation, operation, maintenance and verification requirements. 4.6.2 Pharmaceutical Machinery (equipment) installation shall comply with the relevant provisions of GB 50231-2009. 4.6.3 Pharmaceutical Machinery outer (equipment) in the main conduit is connected fixed line interface, should indicate the name and the contents to the conduit. 4.7 verification Pharmaceutical Machinery (equipment) should meet the requirements of the verification GB/T 28671-2012's.

5 classification requirements

Machinery and equipment drug 5.1 5.1.1 drug should dump machinery and equipment performance, should be able to vent the net discharge, the structure may not have fluid level gauge region. 5.1.2 drug machinery and equipment should be easily disassembled for easy cleaning of the part structure. 5.1.3 drug machinery and equipment in gas and liquid material passage to be sealed reliably, without leakage. 5.1.4 Biological manufacturing equipment should be easy to clean and decontaminate the apparatus for the culture of living organism to be closed, the pipeline design, manufacture, and Installation should be no dead ends, blind tube, piping, valves and breathing filters should be easy to clean, sterilized. Valve closed vessel (e.g., fermentor) should be able to Steam sterilization. Respiratory filter capable of detecting integrity. 5.1.5 centrifuge should an emergency stop, vibration protection and self-locking or excessive vibration alarm device. 5.1.6 Dust filter filtering should be antistatic, no fiber loss. 5.1.7 screening machinery should dust discharge standards or the dust collection device interfaces, dust exhaust. 5.1.8 Use explosion hazardous chemical mediators extraction equipment should be explosion venting devices. 5.1.9 extraction, concentration equipment should adopt a closed system. Extraction, concentration system means during operation of the unit, the heating time, temperature, Extraction time can be set and controlled. 5.1.10 using electromagnetic waves (ultrasonic, microwave, etc.) of the extracting tank; beyond the infrared, microwave, electromagnetic wave drying apparatus as a heat source; dry radiation Dryer; agents to radiation, the source of electromagnetic sterilization apparatus for the sterilization should have shielding, grounding or absorber means. 5.1.11 drying machine should be turned in addition to static grounding and insulation layers. Coping material layer air temperature, humidity and pressure are set and control. 5.1.12 storage device should be installed respirator or breathing filter. It should be able to filter integrity testing. Machinery and equipment 5.2 Formulation 5.2.1 Structure mixing mechanism should facilitate flow into and mix with the material of the particles, the mixing uniformity should be able to meet pharmaceutical technology Seeking, smooth discharge, no accumulation of material, no dust. 5.2.2 fluidized bed granulator, granulation coating machine should be turned in addition to static grounding, air purification with the process apparatus. Final filter should be placed After the heater, the exhaust air should prevent backflow, should exhaust after dust emissions. The main process parameters should be set, adjusted, and controlled display. 5.2.3 Use explosion hazardous chemical media granulator, granulation coating machine and coating machine should have explosion venting devices. 5.2.4 tabletting machine means in contact with the material should be easy to dismantle and clean parameter should be set, adjusted, and display control, overload protection should die Protection function and emergency stop devices. The main process parameters of the coating medium and the flow of drug 5.2.5 coater atomizing gas, the temperature, pressure and the like should be set, control and display. 5.2.6 dosing equipment and piping, valves and filters should be cleaned and sterilized. Mixing uniformity, with the density of the liquid, pH, and other major Parameters should be consistent with the pharmaceutical process requirements. Preparation process temperature, pressure, time and other sterilization parameters should be set, adjusted, control, display, and recording. 5.2.7 medicine plastic bottle washing equipment should eliminate static electricity, the plastic particulate removal apparatus. 5.2.8 filling oral liquid preparations, and liquid dispensing line storage devices, should be easy disassembly, cleaning and disinfection. 5.2.9 powder dispensing, filling precision liquid filling machine should be able to meet the production process, matching "Pharmacopoeia of People's Republic of China" (2010 edition) of the relevant provisions. 5.2.10 integral unit formulation machine (production line) should match control, reliable linkage between the stations should be controlled emergency stop device. should It can automatically adjust the effective local emergency control failures. 5.3 Pharmaceutical milling machinery 5.3.1 Pharmaceutical milling machinery parts in direct contact with the material should be abrasion resistant, pulverized metal particles generated in the pharmaceutical production process should be controlled Within specification requirements. 5.3.2 Pharmaceutical milling machinery (including units) should dust trapping device, the exhaust dust emissions. 5.3.3 produce dust explosion hazards should be mechanically pulverized dust explosion in addition to static guide means and grounding. 5.3.4 Pharmaceutical milling machine feed, the feed should be as mechanical conveying means and means for preventing the metal strayed. 5.4 Mechanical Pieces 5.4.1 winnowing, screening, frying, should cut and broken machinery smoke, dust removal device. Dust, soot should discharge standards. 5.4.2 Washing machine proper drug, water pressure, the feed rate adjusting device. Use of the pharmaceutical water flow, drum type washing machine should be inverted drug, cis Backwashing mechanism, initial wash water cycle unit. 5.4.3 demulcent machine should be able to display, and adjusting the amount of pressure infiltration medium; should be able to dump the material, the discharge opening should be drained; control system should Safety interlocks. 5.4.4 strayed metallic device should be mechanically cut proof. Tool safety devices should be exposed. 5.4.5 frying machine gun Sunburn should be adapted to a variety of methods specified in "People's Republic of China Pharmacopoeia" (2010 edition). 5.4.6 Mechanical fumed drug should insulating layer. 5.4.7 Pieces machinery and related mechanical interfaces should match. Pieces 5.4.8 for mechanical processing of raw materials should have toxic ingredients measures to prevent contamination and cross contamination. 5.5 pharmaceutical water, gas (steam) Equipment 5.5.1 pure distilled water machine and a steam generator where the distilled water (including secondary steam) portion of the material contacting the carbon content should be not more than 0.030%, austenite containing Mo, Cr stainless steel elements. 5.5.2 pure distilled water machine and a steam generator pipe connection should avoid dead ends, blind tube, after shutdown, water drain. Evaporator liquid level should be Display means. 5.5.3 pure distilled water machine and the steam generator should the steam pressure limit alarm means and a safety valve. 5.5.4 pure distilled water machine and steam generator feed water, distilled water, the parameters of the pure steam condensate to be able to detect, display, recording, recovery Su. Level pure electric heater of the steam generator can be set to be, controlled. 5.5.5 Preparation of pure steam, purified water, water for injection devices should be configured to the respective filter, the hydrophobic sterilizing filter and flow, temperature, pressure Strength, pH, and conductivity test equipment, instrumentation. Should be able to filter integrity testing. The main parameters should be on line. 5.5.6 purified water, water for injection preparation, storage and distribution should be able to prevent growth of microorganisms. Purified water cycle should be used for injection Water should be above 70 ℃ incubation cycle. Equipment and piping system should be no dead angle, the blind tube. A pipe joint which joints should be quick junction Configuration, easy disassembly. Water should be provided with appropriate sampling, testing or validation port. The entire system should be able to achieve CIP and sterilization in place. preparation Process flow, temperature, pressure and other parameters should be set, adjusted, control record. 5.5.7 Pharmaceutical water equipment Preparation of purified water, water for injection should follow the "People's Republic of China Pharmacopoeia" (2010 edition) of the relevant provisions. 5.5.8 Pharmaceutical water storage tank should be installed with a respiratory vent filter. 5.6 Pharmaceutical Packaging Machinery 5.6.1 pharmaceutical packaging machinery packaging materials should be used in line with the standard drug packaging materials. 5.6.2 pharmaceutical packaging machinery should adapt to the changes within a certain range of package sizes. It should be able to adjust the speed, coordinated operation, stable, no card Stagnation, no abnormal sound. 5.6.3 filling hopper pharmaceutical packaging machinery, the guide tube (or guide) the inner wall should be smooth, non-blocking, no damage to the material or finished. Filling equipment Set should be easy disassembly, cleaning, packaging machine should function was collected by punching with a punching leftover bits and function. 5.6.4 compressed pharmaceutical packaging machinery, vacuum and cooling pipes should be sealed without leakage. Gas passage means should be oil and water separator, water, trachea Flow regulating passage and pressure should display device. 5.6.5 pharmaceutical packaging machinery control should work status display, and modify the process parameters set, fault alarm function. 5.6.6 pharmaceutical packaging linked unit (line) should match control, reliable, and can effectively control the local emergency fault. 5.6.7 pharmaceutical packaging machinery due security door, hood, protective door safety interlocks should be. 5.6.8 batch number should be legible print, the print media are using drugs and not pollute the environment. 5.7 Drug Detection Device 5.7.1 Drug detection performance testing equipment shall meet the "People's Republic of China Pharmacopoeia" (2010 version) requirements on drug testing and The relevant provisions. 5.7.2 TOC detecting means should be able to distinguish between organic carbon and inorganic carbon, and can eliminate the interference of inorganic carbon measurement of organic carbon. Detection accuracy The degree and scope of application should follow the "People's Republic of China Pharmacopoeia" (2010 edition) of the relevant provisions. 5.7.3 conductivity meter should automatic temperature compensation function. Detection accuracy and scope of application should follow the "People's Republic of China Pharmacopoeia" (2010 editi...

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