GB 28670-2012

Active

General rule of pharmaceutical machinery conforming to good manufacturing practice

制药机械(设备)实施药品生产质量管理规范的通则

Standard Type
GB
ICS
11.120
CCS
C90
Status
Active
Issue Date
2012-09-03
Implementation
2013-07-01
Centralized Committee
工业和信息化部
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the general requirements for the design, manufacturing, installation, and maintenance of pharmaceutical machinery to ensure compliance with Good Manufacturing Practice (GMP) regulations. It is applied in the pharmaceutical industry for equipment used in drug production, such as mixers, granulators, and packaging machines, to prevent contamination and ensure product quality. The standard is also referenced during factory acceptance testing and qualification processes for new or modified pharmaceutical equipment.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.