Analysis and application of Article 59 stipulated in the appendix for biological products in China's Good Manufacturing Practice
10.13200/j.cnki.cjb.004667
- VernacularTitle:中国《药品生产质量管理规范》生物制品附录第59条的解析与应用
- Author:
Ying KANG
1
Author Information
1. Center for Food and Drug Inspection of NMPA, Beijing 100076, China
- Publication Type:Journal Article
- Keywords:
Good Manufacturing Practice appendix for biological products;
Information technology;
Manufacturing Execution System(MES);
Laboratory Information Management System(LIMS);
Data integrity
- From:
Chinese Journal of Biologicals
2026;39(03):374-384
- CountryChina
- Language:Chinese
-
Abstract:
The Article 59 stipulated in the appendix for Biological Products in China's Good Manufacturing Practice(GMP)mandates that vaccine manufacturers adopt information technology systems for the recording of all production and quality control data, thereby ensuring comprehensive traceability and compliance throughout the entire manufacturing lifecycle.The regulation is designed to mitigate the significant risks inherent in traditional paper-based documentation systems,including their susceptibility to loss, inadvertent damage, and deliberate tampering, with the ultimate goal of ensuring robust data integrity. This paper provides a critical analysis of this regulatory provision The implementation of Manufacturing Execution System(MES) and Laboratory Information Management System(LIMS) serves as the foundational approach to facilitate real-time monitoring, enforce automated data capture and archiving, and implement stringent access controls. Such technological infrastructure is essential for enhancing the management of Critical Process Parameters(CPPs) and Critical Quality Attributes(CQAs). This paper further examines the principal implementation challenges and proposes corresponding solutions for MES and LIMS deployment, with a focus on data acquisition interoperability, cryptographic assurance of data integrity, and necessary business process re-engineering. Additionally, the paper delineates key focus areas for regulatory inspections, including data integrity and validation of computerized systems. The findings offer a systematic framework to guide vaccine manufacturers in achieving regulatory compliance and advancing their digital maturity.
