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1、SCHEDULE M See Rules 71, 74, 76 and 78 GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. Note: - To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and
2、maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein. PART 1 GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS. 1. GENERAL REQUIREMENTS 1.1. Location and surroun
3、dings.- The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environmental including open sewage, drain, public lavatory or any factory which product disagreeable or obnoxious odour, fumes, excessive soot,
4、dust, smoke, chemical or biological emissions. 1.2. Building and premises.- The building(s) used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the condit
5、ions laid down in the Factories Act, 1948 (63 of 1948) The premises used for manufacturing, processing, warehousing, packaging labeling and testing purposes shall be . _ Omitted by G.O.I.Notification No.G.S.R.462(E) dt.22.06.1982. Ins.by G.O.I.Notification NoG.S.R.864(E) dt.11.12.2001.- applicable t
6、o manufacturers licensed to manufacture drugs, for the period upto 31.12.2003. (i) compatible with other drug manufacturing operations that may be carried out in the same or adjacent area / section; (ii) adequately provided with working space to allow orderly and logical placement of equipment, mate
7、rials and movement of personnel so as to: (a) avoid the risk of mix- up between different categories of drugs or with raw materials, intermediates and in- process material; (b) avoid the possibilities of contamination and cross- contamination by providing suitable mechanism; (iii) designed / constru
8、cted / maintained to prevent entry of insects, pests, birds, vermins, and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection; (iv) air- conditioned, where prescribed for the operations and dosage froms unde
9、r production. The production and dispensing areas shall be well lighted, effectively ventilated, with air control facilities and may have proper Air Handling Units (wherever applicable) to maintain conditions PDF 文件使用 “pdfFactory Pro“ 试用版本创建 including temperature and, wherever necessary, humidity, a
10、s defined for the relevant product. These conditions shall be appropriate to the category of drugs and nature of the operation. These shall also be suitable to the comforts of the personnel working with protective clothing, products handled, operations undertaken within them in relation to the exter
11、nal environment. These areas shall be regularly monitored for compliance with required specifications; (v) Provided with drainage system, as specified for the various categories of products, which shall be of adequate size and so designed as to prevent back flow and/or prevent insets and rodents ent
12、ering the premises. Open channels shall be avoided in manufacturing areas and, where provided, these shall be shallow to facilitate cleaning and disinfection; (vi) The walls and floors of the areas where manufacture of drugs is carried out shall be free from cracks and open joints to avoid accumulat
13、ion of dust. These shall be smooth, washable, covered and shall permit easy and effective cleaning and dis- infection. The interior surfaces shall not shed particles. A periodical record of cleaning and painting of the premises shall be maintained. 1.3 Water System. - There shall be validated system
14、 for treatment of water drawn from own or any other source to render it potable in accordance with standards specified by the Bureau of Indian Standards or Local Municipality, as the case may be, so as to produce Purified Water conforming to Pharmacopoeial specification. Purified Water so produced s
15、hall only be used for all operations except washing and cleaning operations where potable water may be used. Water shall be stored in tanks, which do not adversely affect quality of water and ensure freedom from microbiological growth. The tank shall be cleaned periodically and records maintained by
16、 the licensee in this behalf. 1.4. Disposal of waste. (i) The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall be in conformity with the requirements of Environment Pollution Control Board. (ii) All bio- medical waste shall be destroyed as per the provisions of the Bio- Medical Waste (
