Update of the GMP Guideline for Sterile Medicinal Products in China

Following the publication of Annex 1, the WHO and PICs have already published comparable documents. Now the Chinese Medicines and Medical Devices Administration (NMPA) has published a draft regarding new GMP requirements for sterile medicinal products on 17 March 2025.

The draft defines precise requirements for the manufacture, control and quality management of such products. The focus is on the introduction of a comprehensive contamination control strategy (CCS) that integrates all processes, facilities and employee activities. The aim is to minimise the risk of microbial, particulate or pyrogenic contamination at every stage of production.

The design of cleanroom areas with graded cleanliness classes (A to D) and the implementation of advanced barrier concepts such as isolators and RABS (Restricted Access Barrier Systems) also play a key role. These systems are designed to effectively shield the critical zones of pharmaceutical production from potential sources of contamination. Seamless validation and regular checks of the air flow, pressure conditions and cleaning measures are planned.

The aspect of risk-based quality management is particularly emphasised. Companies should analyse all critical production steps and equipment and define suitable control measures on the basis of scientifically sound risk assessments. The responsibility for maintaining a functioning quality and risk management system clearly lies with senior management.

The requirements for personnel have also been significantly tightened. All employees working in production must be regularly trained, assessed and demonstrably qualified. Access regulations to the cleanroom areas are strictly regulated and behaviour within the zones is subject to clear, documented guidelines. The selection and care of work clothing is also subject to defined standards.

In addition, the draft describes in detail the requirements for technical equipment, water and air systems as well as the cleaning, disinfection and sterilisation processes. In particular, the use of alternative, rapid test methods for microbiological monitoring is encouraged, provided their effectiveness has been validated.

Overall, like the well-known Annex 1, the draft aims to raise the manufacture of sterile medicinal products to a higher technological and regulatory level in order to fulfil national and international quality standards and ensure patient safety in the long term. Pharmaceutical companies are invited to comment by 30 May 2025. As there is no official translation yet, you can read the Chinese document on the NMPA website.