T/SPPEA 0001-2021 Active Group standards

T/SPPEA 0001-2021 Quality Management Guidelines for the Production of Pharmaceutical Additives

Publish Date: 2018-04-19 Implement Date: 2018-04-19 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/SPPEA 0001-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: The excipients used in pharmaceutical preparations and other substances

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2018-04-19

Implement Date: 2018-04-19

Scope

Main technical content: This standard applies to the production of excipients meeting pharmaceutical requirements, covering the quality management system and the scope of production quality management required for the entire production process. It will guide enterprises to determine the rationality of the facilities and control measures adopted in the production of excipients, as well as to determine the quality and safety requirements of excipients, ensuring that they are suitable for the intended use and customer requirements. Pharmaceutical excipients produced for special purposes should comply with the corresponding requirements for their intended use and meet the management regulations of the local competent authorities, which will not be described separately in this guide. Such as (including but not limited to): excipients used for injection, ophthalmic use, inhalation, and open wounds; as well as sterile and/or pyrogen-free excipients. This standard is based on the "Quality Management Code for the Production of Pharmaceutical Excipients" (No. [2006] 120 of the National Food and Drug Administration) and refers to the "Quality Management Code for Pharmaceutical Production (Revised in 2010)" (Decree No. 79 of the Ministry of Health) and its Appendix 2 related requirements for APIs, regulating the quality management system adopted in the production of pharmaceutical excipients, giving full play to the guidance and leading role of the Jiangsu Pharmaceutical Packaging and Excipients Association (hereinafter referred to as the Association) in the production of pharmaceutical excipients enterprises, and specially formulating the Quality Management Guide for the Production of Pharmaceutical Excipients. This standard is the first "Quality Management Guide for the Production of Pharmaceutical Excipients" after the associated review of pharmaceutical excipients in the national drug reform, and it is also a standard for third-party audits in cooperation with the Internati