On January 2, 2025, China's National Medical Products Administration (NMPA) released two appendices to the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging materials respectively. These appendices will come into effect on January 1, 2026. Before this date, manufacturers of pharmaceutical excipients and packaging materials must upgrade their facilities and enhance their quality management systems to fully comply with the new requirements.
Key Requirements for Pharmaceutical Excipients and Packaging Materials Manufacturers
1. Establishing and Strengthening Quality Management Systems
Manufacturers must develop comprehensive quality management systems that align with the requirements of the appendices. They should:
Ensure adequate organizational and personnel resources proportional to production scale.
Maintain detailed management documents, operational procedures, and records.
Conduct regular quality evaluations of raw material suppliers.
Organize production based on the registered information (e.g., company name, production address, formula, and process) in the NMPA's Drug Evaluation Center (CDE) platform.
Test each product batch against quality standards and release them only after approval by the quality management department.
2. Implementing Change Management Systems
Manufacturers must establish a change management system to assess and categorize changes during production based on risk. Changes can only be implemented after thorough research and approval by the quality management department. Updates must also be submitted to the CDE platform, and marketing authorization holders (MAHs) should be informed promptly.
3. Supporting MAHs in Quality Audits
Manufacturers are required to support MAHs by:
Allowing access to relevant facilities and areas.
Providing authentic, complete, and effective documents and records.
Assisting in quality management activities, including complaints, returns, and recalls.
If outsourced testing is involved, manufacturers must sign agreements with testing institutions to ensure the reliability of results.
Key Requirements for Marketing Authorization Holders
1. Strict Management of Excipients and Packaging Materials
MAHs must maintain robust quality management systems, sign quality agreements with key manufacturers of excipients and packaging materials, and ensure their products meet pharmaceutical requirements and intended purposes.
2. Enhancing Supplier Audits
MAHs must evaluate and approve all suppliers, including manufacturers and distributors in accordance with the appendices' requirements. They should maintain supplier quality archives and conduct regular quality assessments. On-site audits of key suppliers should also be conducted periodically based on risk management principles.
3. Strengthening Quality Control and Inspection
MAHs must evaluate the quality control and product release capabilities of manufacturers and conduct stringent incoming inspections of excipients and packaging materials. When necessary, they should increase inspection items based on risk assessments and intended use.
4. Improving Change Management
MAHs must track changes in excipients and packaging materials, assess their impact on drug quality, and conduct relevant studies in compliance with drug change management regulations. Any changes or additions to excipients or packaging material suppliers must be handled according to post-market change management requirements.
