T/GDPA 1-2024 Active Group standards

T/GDPA 1-2024 Guidance for Quality Management of Pharmaceutical Additives Production

Publish Date: 2024-05-09 Implement Date: 2024-05-09 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/GDPA 1-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2024-05-09

Implement Date: 2024-05-09

Scope

Main technical content: The "Guide for Quality Management of Pharmaceutical Excipients Production" combines the operation of the quality management system of pharmaceutical excipients production enterprises in Guangdong Province, the characteristics of excipient production, and the relevant management regulations for the national evaluation of the relationship between pharmaceutical excipients and drug preparations. Based on the "Quality Management Guidelines for Pharmaceutical Excipients Production" (No. 120 [2006] of the National Food and Drug Administration), the "Quality Management Guidelines for Drug Production" (revised in 2010) (Decree No. 79 of the Ministry of Health) and its Appendix 2 on APIs, the "Guide for Quality Management of Pharmaceutical Excipients Production (Draft for Comment)" focuses on all factors affecting the quality of excipients, keeping up with new regulatory requirements, with detailed content, comprehensive coverage, and strong guidance. At the same time, it aligns with international standards, referring to the "Quality Management Guidelines for Pharmaceutical Excipients Production (<1078>)" issued by the United States Pharmacopeial Convention (USP) in 2013 and the "Guide for Quality Management of Pharmaceutical Excipients Production" issued by the International Pharmaceutical Excipients Council (IPEC) in 2022, etc. It pays more attention to customer communication and service, as well as data analysis and continuous improvement. In addition, it encourages the application of Process Analytical Technology (PAT). The main contents include general provisions, quality management, institutions and personnel, etc. (I) General provisions. It clarifies the purpose of formulating the guide, the legal basis, the scope of application, and the applicable objects. (II) Quality management. It clarifies the principles and requirements of quality management, and proposes quality risk management throughout the product life cycle. (III) Management of the p