T/TFHT J018-2019 Abolished Group standards

T/TFHT J018-2019 Meat Cistanche Processing Technical Specification

Publish Date: 2019-06-13 Implement Date: 2019-06-13 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/TFHT J018-2019

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Economic forests and by-products

ICS Name: Drugs

Publish Date: 2019-06-13

Implement Date: 2019-06-13

Scope

Main Technical Content: 3. Production Resources 3.1 Production Site (Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010)) The layout, design, construction, and maintenance of factory buildings must comply with pharmaceutical production requirements, and should minimize the risk of contamination, cross-contamination, mix-ups, and errors, while facilitating cleaning, operation, and maintenance. The site selection and design of factory buildings should be comprehensive, and the surrounding environment should minimize the risk of material or product contamination. The enterprise should maintain a clean production environment; the factory grounds, pavements, and transportation systems should not cause pollution to pharmaceutical production; the overall layout of production, administrative, living, and auxiliary areas should be reasonable and not interfere with each other; and the flow of people and materials within the factory and buildings should be rational. Factory buildings should be properly maintained to ensure that maintenance activities do not affect drug quality. Cleaning or necessary disinfection of factory buildings should be carried out according to detailed written procedures. The design and layout of factory buildings should provide appropriate lighting, temperature, humidity, and ventilation to ensure that the quality of produced and stored products, as well as the performance of related equipment, are not directly or indirectly affected. Factory buildings and facilities should be designed and installed to effectively prevent the entry of insects or other animals. Necessary measures should be taken to avoid contamination of equipment, materials, and products by rodenticides, insecticides, and fumigants. Appropriate measures should be taken to prevent unauthorized personnel from entering. Production, storage, and quality control areas should not serve as direct passageways for non-authorized personnel. Factory buildin