Chapter I General
Article 1.0.1 In order to implement the national "Good Manufacturing Practice" (hereinafter referred to as GMP), to put forward in line with the GMP requirements for the design of production plants, facilities and equipment, the formulation of this specification.
Article 1.0.2 This specification applies to the new construction, alteration and expansion of pharmaceutical preparations, raw materials and pharmaceutical excipients, refining, drying, packaging processes, direct contact with pharmaceutical packaging materials, sterile medical devices and other pharmaceutical industry clean plant design.
Article 1.0.3 The pharmaceutical industry clean plant design must implement the relevant national guidelines and policies. To achieve advanced technology, quality assurance, safety and practical, economical and reasonable, in line with the requirements of energy conservation and environmental protection.
Article 1.0.4 The design of clean plants in the pharmaceutical industry should not only meet the current production process requirements, but also should give due consideration to the future development of production and process improvement needs.
Article 1.0.5 In the use of the original building and facilities for clean technology transformation, according to the requirements of the production process, from a practical point of view, make full use of the existing technical facilities, in line with the principle of local conditions.
Article 1.0.6 The design of clean plants for the pharmaceutical industry shall create the necessary conditions for construction and installation, maintenance, management, overhaul, testing and safe operation.
Article 1.0.7 In addition to the implementation of this specification, the design of clean plants in the pharmaceutical industry should also comply with the current national standards, norms and regulations of the relevant requirements.
Chapter 2 Environmental Parameters of Production Areas
Section 1 General Provisions
Chapter 3 Site Selection and General Layout
Section 1 Site Selection
Article 3.1.1 The selection of the location of the clean plant of the pharmaceutical industry shall be based on the following principles, which shall be determined by comparison of the technical and economic programs:
A. The location of the clean plant shall be in the area where the concentration of dust and bacteria is low. Containing dust, bacteria, low concentration, no harmful gases, the natural environment of the region;
Two, should be far from railroads, docks, airports, major transportation routes and emit a large amount of dust and harmful gases of factories, storage warehouses, yards and other serious air pollution, water pollution, vibration or noise interference in the region. If it can not be far away from the serious air pollution area, it should be located in its maximum frequency of wind direction upwind side, or the minimum frequency of wind direction throughout the year downwind side.
Article 3.1.2 The distance between clean plants of pharmaceutical industry and municipal traffic arteries should not be less than 50m.
Section 2: General Layout
Chapter 4: Process Design
Process Layout: Purification of Personnel, Purification of Material
Chapter 5: Equipment
Chapter 6: Process Piping
Section 1: General Provisions
Section 2: General Provisions
Section 3.1.1: Clean Plant Distance from the Municipal Transportation Arterial Roads
Section 2: Piping materials, valves and accessories
Section 3: Installation and heat preservation of pipelines
Section 4: Safety
Chapter 7: Construction
Section 1: General provisions
Article 7.1.1: The building plan and spatial layout shall be appropriately flexible. The main structure of the clean area should not use internal wall bearing.
Article 7.1.2 The height of the clean room shall be controlled by the net height, and the net height shall be 100mm as the basic module.
Article 7.1.3 The durability of the main structure of the clean room of the pharmaceutical industry shall be coordinated with the level of indoor equipment and decoration, and it shall have the performance of fireproofing, controlling the temperature deformation and uneven subsidence. Expansion joints of the plant shall pass through the clean area.
Article 7.1.4 The clean area shall be equipped with technical mezzanine or technical mezzanine for arranging the air supply and return ducts and other pipelines.
Article 7.1.5 The passageway in the clean area shall be of appropriate width to facilitate material transportation, equipment installation and maintenance.
Section 2: Fire prevention and evacuation
Section 3: Indoor decoration
Chapter 8: Air purification
Section 1: General provisions
Article 8.1.1: Determination of air cleanliness level of each clean room of the clean factory of the pharmaceutical industry shall conform to the following requirements:
I. Different requirements, the use of different air cleanliness level;
Two, in order to meet the requirements of the production process, the clean room air flow organization, it is appropriate to use the local work area air purification and air purification of the whole room in the form of a combination.
Article 8.1.2 clean room temperature, humidity, fresh air volume, differential pressure and other environmental parameters of control should be consistent with the second chapter of the second section.
Section 2: Clean air conditioning system
Section 3: Airflow organization
Section 4: Ducts and accessories
Section 5: Special requirements for clean room for penicillin and other drugs production
Chapter 9: Water supply and drainage
Section 1: General provisions
Article 9.1.1: Water supply and drainage trunk pipelines within the clean area shall be laid in technical mezzanines, technical raceways or buried underground.
Article 9.1.2 The pipeline shall be laid sparingly in the clean room, and the branch pipe introduced into the clean room shall be concealed.
Article 9.1.3 The outer surface of the pipeline in the clean room of the pharmaceutical industry shall take measures to prevent condensation.
Article 9.1.4 The water supply and drainage branch pipe through the clean room ceiling, wall and floor should be set up at the casing, piping and casing must have a reliable sealing measures.
Section 2 Water Supply
Section 3 Drainage
Section 4 Process Water
Section 5 Fire-fighting Facilities
Chapter 10 Electricity
Section 1 Power Distribution
Section 2 Lighting
Section 3 Other Electricity
Section 3.1.4 The water supply and drainage pipes shall be installed in the clean room.