What are the GMP requirements of pharmaceutical preparation workshop?

The first is the preparation workshop for producing drugs, which is closely related to the air purification system.

Secondly, version 20 10 GMP has been implemented since March 20 1 1 year, which should be combined with the requirements of the new GMP. Attached below are the contents of the factory buildings and facilities, which I hope will be useful to you.

Good manufacturing practices (revised 20 10)

(Decree No.79 of the Ministry of Health) Chapter IV Factories and Facilities

Section 1 Original Rules

Article 38 The site selection, design, layout, construction, renovation and maintenance of the factory building must meet the requirements of pharmaceutical production, and can avoid pollution, cross-contamination, confusion and errors to the greatest extent, so as to facilitate cleaning, operation and maintenance.

Article 39 The site selection shall be based on the comprehensive consideration of the factory building and production protection measures, and the environment in which the factory building is located shall be able to minimize the pollution risk of materials or products.

Fortieth enterprises should have a clean and tidy production environment; The ground, road surface and transportation of the factory should not cause pollution to drug production; The overall layout of production, administration, living and auxiliary areas shall be reasonable and shall not interfere with each other; The direction of people flow and logistics in factories and workshops should be reasonable.

Article 41 The workshop shall be properly maintained, and the maintenance activities shall not affect the quality of drugs. The workshop shall carry out necessary cleaning or disinfection according to detailed written operation procedures.

Article 42 The workshop should have proper lighting, temperature, humidity and ventilation to ensure that the quality of products produced and stored and the performance of related equipment will not be directly or indirectly affected.

Article 43 Factories and equipment shall be designed and set up to effectively prevent insects or other animals from entering. Necessary measures should be taken to avoid using rodenticide, insecticide, fumigant and other pollution to equipment, materials and products.

Article 44 Appropriate measures shall be taken to prevent unauthorized personnel from entering. Production, storage and quality control areas should not be used as direct entrances for non-local employees.

Article 45 As-built drawings of factories, public facilities, fixed pipelines and other projects after construction or transformation shall be kept.

Section 2 Production Area

Article 46 In order to reduce the risk of pollution and cross-contamination, factories, production facilities and equipment should be designed, arranged and used reasonably according to the characteristics, technological processes and corresponding cleanliness levels of the drugs produced, and the following requirements should be met:

(1) It shall comprehensively consider the characteristics, processes and expected uses of drugs, determine the feasibility of using multiple products in factories, production facilities and equipment, and make corresponding evaluation reports;

(2) To produce drugs with special properties, such as highly allergic drugs (such as penicillin) or biological products (such as BCG or other drugs prepared with active microorganisms), special and independent workshops, production facilities and equipment must be adopted. The working area with large dust production of penicillin drugs should maintain a relative negative pressure, the exhaust gas discharged should be purified and meet the requirements, and the exhaust port should be far away from the air inlet of other air purification systems;

(3) The production of β -lactam drugs and sex hormone contraceptives must use special facilities (such as independent air purification system) and equipment, and be strictly isolated from other drug production areas;

(4) Special facilities (such as independent air purification systems) and equipment shall be used for the production of certain hormones, cytotoxic chemicals and highly active chemicals; Under special circumstances, if special protective measures are taken and necessary verification is carried out, the above-mentioned pharmaceutical preparations can be produced by stages with the same production facilities and equipment;

(5) The exhaust of the air purification system used in items (2), (3) and (4) above shall be purified;

(six) pharmaceutical manufacturers shall not produce non-medicinal products that have adverse effects on the quality of drugs.

Article 47 The production area and storage area should have enough space to ensure the orderly storage of equipment, materials, intermediate products, products to be packaged and finished products, to avoid confusion and cross-contamination of different products or materials, and to avoid omissions or errors in production or quality control operations.

Article 48 An air-conditioning purification system shall be configured according to drug varieties, production operation requirements and external environmental conditions, so that the production area can be effectively ventilated, and temperature and humidity control and air purification and filtration shall be provided to ensure that the drug production environment meets the requirements.

The pressure difference between clean zone and non-clean zone and between clean zones of different grades shall be no less than 10 Pascal. When necessary, appropriate pressure gradient should be maintained between different functional areas (operating rooms) to maintain the same cleanliness level.

The exposure process areas for the production of non-sterile preparations such as oral liquid and solid preparations, oral drugs (including rectal administration) and drugs for external use on epidermis, as well as the exposure process areas for the final treatment of packaging materials that are in direct contact with drugs, shall be set up according to the requirements of Class D clean areas in the appendix of Sterile Drugs, and enterprises may take appropriate microbial monitoring measures in this area according to the standards and characteristics of products.

Article 49 The inner surface (wall, floor and ceiling) of the clean area shall be smooth, crack-free, with tight joints and no particles falling off, so as to avoid dust accumulation and facilitate effective cleaning. When necessary, disinfection should be carried out.

Article 50 The design and installation of various pipelines, lighting facilities, tuyeres and other public facilities should avoid the parts that are difficult to clean and keep them outside the production area as far as possible.

Fifty-first drainage facilities should have an appropriate scale and be equipped with devices to prevent backflow. Open ditch drainage should be avoided as much as possible; When it is inevitable, the open ditch should be shallow to facilitate cleaning and disinfection.

Article 52 The weighing of preparation raw materials and auxiliary materials should usually be carried out in a specially designed weighing room.

Article 53 Workshops that generate dust (such as sampling, weighing, mixing and packaging of dry materials or products) should maintain a relative negative pressure or take special measures to prevent dust from spreading, avoid cross-contamination and facilitate cleaning.

Article 54 Factories or areas used for drug packaging should be designed and laid out rationally to avoid confusion or cross-contamination. Since there are several packaging lines in an area, there should be isolation measures.

Article 55 The production area should have proper lighting, and the lighting in the visual operation area should meet the operation requirements.

Article 56 An intermediate control area may be set up in the production area, but the intermediate control operation shall not bring quality risks to drugs.

Section III Storage Area

Article 57 The storage area should have enough space to ensure the orderly storage of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products to be inspected, qualified, unqualified, returned or recalled.

Article 58 The design and construction of storage areas shall ensure good storage conditions and have ventilation and lighting facilities. The storage area should be able to meet the requirements of storage conditions (such as temperature and humidity, light protection) and safe storage of materials or products, and carry out inspection and monitoring.

Fifty-ninth high activity materials or products and printing and packaging materials should be stored in a safe area.

Article 60 The receiving, distributing and shipping areas should be able to protect materials and products from the influence of external weather (such as rain and snow). The layout and facilities of the receiving area should ensure that the incoming materials can be cleaned before entering the storage area.

Article 61 Where a separate isolated area is used to store materials to be inspected, it shall be clearly marked in the area to be inspected, and the entry and exit of approved personnel shall be restricted.

Unqualified, returned or recalled materials or products shall be stored in isolation.

If other methods are used instead of physical isolation, this method should have the same security.

Article 62 In general, there should be a separate material sampling area. The air cleanliness level in the sampling area should meet the production requirements. If samples are taken in other areas or in other ways, pollution or cross-contamination should be prevented.

The fourth quarter quality control area

Article 63 Quality control laboratories should usually be separated from production areas. Bioassay, microbiology and radioisotope laboratories should also be separated from each other.

Article 64 The design of a laboratory shall ensure that it is suitable for the intended purpose and can avoid confusion and cross-contamination. There should be enough area for sample treatment, sample retention, storage of stability test samples and preservation of records.

Article 65 When necessary, a special instrument room should be set up to protect high-sensitivity instruments from static electricity, vibration, humidity or other external factors.

Article 66 Laboratories handling biological samples, radioactive samples and other special articles shall meet the relevant requirements of the state.

Article 67 The laboratory animal room shall be strictly isolated from other areas, its design and construction shall conform to the relevant provisions of the state, and it shall be equipped with independent air treatment facilities and special passages for animals.

Section 5 Auxiliary Area

Article 68 The establishment of lounge shall not adversely affect the production area, storage area and quality control area.

Sixty-ninth dressing rooms and bathrooms should be convenient for people to enter and exit, and adapt to the number of users. Toilets should not directly communicate with production areas and storage areas.

Article 70 the maintenance room should be as far away from the production area as possible. Maintenance spare parts and tools stored in clean areas should be placed in special rooms or tool cabinets.

Chapter V Equipment

Section 1 Original Rules

Article 71 The design, selection, installation, modification and maintenance of equipment must conform to the intended use, minimize the risk of pollution, cross-contamination, confusion and mistakes, facilitate operation, cleaning and maintenance, and carry out disinfection or sterilization when necessary.

Article 72 Operating rules for the use, cleaning, maintenance and repair of equipment shall be established, and corresponding operating records shall be kept.

Article 73 Documents and records of equipment procurement, installation and confirmation shall be established and kept.

Section 2 Design and Installation

Article 74 Production equipment shall not adversely affect the quality of drugs. The surface of production equipment in direct contact with drugs should be smooth, flat, easy to clean or disinfect, corrosion-resistant, and must not react chemically with drugs, adsorb drugs or release substances into drugs.

Article 75 Weighing instruments, measuring tools, instruments and meters with appropriate measuring range and accuracy shall be equipped.

Article 76 Appropriate cleaning and cleaning equipment shall be selected, and the equipment shall be prevented from becoming a pollution source.

Article 77 Lubricants and coolants used in equipment shall not pollute drugs or containers, and edible or equivalent lubricants shall be used as far as possible.

Article 78 The procurement, acceptance, storage, maintenance, distribution and scrapping of production molds shall follow the corresponding operating rules, and shall be kept by a special counter and recorded accordingly.

Section 3 Maintenance and Repair

Article 79 Maintenance and repair of equipment shall not affect product quality.

Article 80 A preventive maintenance plan and operating rules for equipment shall be formulated, and equipment maintenance and repair records shall be kept.

Article 81 Equipment that has been modified or overhauled must be reconfirmed before it can be used in production.

Section 4 Use and Cleaning

Eighty-second major production and inspection equipment should have clear operating procedures.

Article 83 Production equipment shall be used within the defined parameters.

Article 84 The cleaning of production equipment shall be carried out in accordance with detailed operating procedures.

The Operating Rules for Cleaner Production Equipment shall specify specific and complete cleaning methods, names and preparation methods of cleaning equipment or tools, cleaning agents, methods for removing marks of previous batch, methods for preventing pollution of cleaning equipment before use, the longest storage period of cleaning equipment, and methods for checking the cleaning status of equipment before use, so that operators can clean various equipment in a repeatable and effective way.

If it is necessary to disassemble the equipment, it should also explain the sequence and method of disassembling the equipment; If it is necessary to disinfect or sterilize the equipment, it should also explain the specific disinfection or sterilization method, the name of the disinfectant and the preparation method. When necessary, the maximum time interval between the end of equipment production and cleaning shall be specified.

Article 85 Cleaned production equipment shall be stored in a clean and dry environment.

Article 86 Equipment and instruments used for drug production or inspection shall have a usage log to record the usage, cleaning, maintenance and repair, date and time, name, specification and batch number of the drugs produced and inspected.

Article 87 Production equipment shall have obvious status identification, indicating the equipment number and content (such as name, specification and batch number); If there is no content, it should be marked as clean.

Eighty-eighth unqualified equipment should be moved out of the production and quality control area, and there should be eye-catching status signs before moving out.

Eighty-ninth main fixed pipes should be marked with the name and flow direction of the contents.

Section 5 Calibration

Article 90 Weighing instruments, measuring tools, meters, recording and control equipment and instruments used in production and inspection shall be calibrated and inspected regularly in accordance with the operating rules and calibration plans, and relevant records shall be kept. The calibration scope should cover the actual production and inspection scope.

Article 91 Key weighing instruments, measuring tools, meters, recording and control equipment and instruments used in production and inspection shall be calibrated, and the obtained data shall be accurate and reliable.

Article 92 Standard instruments of measurement shall be used for calibration, and the used standard instruments of measurement shall conform to the relevant provisions of the state. Calibration records shall indicate the name, number, calibration validity period and number of measurement certificate of standard instruments used to ensure the traceability of the records.

Article 93 Weighing instruments, measuring tools, meters, recording control equipment and instruments shall be clearly marked to indicate their calibration validity period.

Article 94 Weighing instruments, measuring tools and meters, as well as equipment and instruments used for recording and control, which are not calibrated, exceed the validity period of calibration and are inaccurate shall not be used.

Article 95 Where automatic and electronic equipment is used in the process of production, packaging and storage, it shall be calibrated and tested regularly in accordance with the operating rules to ensure its normal operation. Calibration and inspection shall be recorded accordingly.

Section 6 Pharmaceutical Water

Article 96 Pharmaceutical water shall be suitable for its purpose and meet the quality standards and relevant requirements of China Pharmacopoeia. At least drinking water should be used for pharmaceutical water.

Article 97 The design, installation, operation and maintenance of water treatment equipment and its conveying system shall ensure that pharmaceutical water meets the prescribed quality standards. The operation of water treatment equipment shall not exceed its design capacity.

Article 98 Materials used for storage tanks and pipelines of purified water and water for injection shall be non-toxic and corrosion-resistant; The exhaust port of the storage tank should be equipped with a hydrophobic sterilization filter that does not shed fibers; The design and installation of pipelines should avoid dead corners and blind pipes.

Article 99 The preparation, storage and distribution of purified water and water for injection shall be able to prevent the growth of microorganisms. Purified water can be circulated, and water for injection can be circulated above 70℃.

Article 100 The quality of pharmaceutical water and raw water shall be monitored regularly and recorded.

Article 101 Pipelines for purified water and water for injection shall be cleaned and disinfected in accordance with the operating rules, and relevant records shall be kept. When the microbial pollution of pharmaceutical water reaches the warning limit and rectification limit, it should be treated according to the operating procedures.