T/TFHT J015-2019 Abolished Group standards

T/TFHT J015-2019 Astragalus Processing Technology Specifications

T/TFHT J015-2019

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 J015-2019

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Economic crops

ICS Name: Drugs

Publish Date: 2019-06-13

Implement Date: 2019-06-13

Scope

Main Technical Content: 3.1 Terminology and Definitions 3.1 Huangqi Tablets Huangqi tablets are thick slices with a roughly round or oval shape. The outer surface is yellow-white to light brown, with visible longitudinal wrinkles or grooves. The cross-section shows a yellow-white cortex and a pale yellow xylem, with radial patterns and cracks. Some may exhibit central areas of dry or decayed tissue, blackish-brown or hollow. They have a faint odor and a slightly sweet taste, but may have a nutty aftertaste when chewed. 4. Production Resources 4.1 Production Site (Good Manufacturing Practice for Pharmaceutical Products (Revised 2010)) Factory Environment The location, design, layout, construction, renovation, and maintenance of factory buildings must meet pharmaceutical production requirements, minimizing contamination, cross-contamination, confusion, and errors, and facilitating cleaning, operation, and maintenance. The site selection for factory buildings should comprehensively consider production requirements, and the environment of the factory buildings should minimize the risk of material or product contamination. Enterprises should maintain a clean production environment. The factory floor, road surfaces, and transportation systems should not contaminate drug production. The overall layout of production, administrative, living, and auxiliary areas should be reasonable and not interfere with each other. 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. Design and Layout Factory buildings should have appropriate lighting, temperature, humidity, and ventilation to ensure that the quality of produced and stored products and the performance of related equipment are not direct