English (UK) 
简体中文 Foundational issues: the nature and value of accreditation
1. What is GMP certification?
GMP (Good Manufacturing Practice) is a mandatory quality control system implemented by the state for pharmaceutical manufacturers, covering the entire process of raw material procurement, production environment, process flow, quality control, etc. The core of GMP is to ensure the safety, efficacy and quality stability of pharmaceutical products through standardised operational practices. The core of GMP is to ensure the safety, efficacy and quality stability of medicines through standardised work practices. China has formally implemented GMP certification since 1995, and enterprises that have not passed the certification are not allowed to produce new drugs or obtain production licences.
2. Why is it important to choose a GMP certified factory?
Certified factories offer three major advantages:
- Compliance Assurance: The NDA regularly updates the certification list (e.g., 2025 announcement) to include only companies that are legally qualified to manufacture;
- International recognition: Certified medicines can apply for export sales certificates to enhance the competitiveness of international trade;
- Quality First Procurement: Medical institutions and business units need to prioritise the procurement of GMP-certified medicines, creating an endorsement of trust in the market.
Scenario Problem: Access to Directories and Screening Strategies
1. Where can I find a list of authoritative certified factories?
Two types of official channels provide real-time updates:
- Provincial Pharmacovigilance Bulletin: For example, the catalogue of GMP compliance inspection companies published in Hebei Province 2025 contains Hebei Orange Well Pharmaceuticals (solid preparations) and Hebei Ruijitang (Chinese medicine extraction);
- Announcement of certification by the State Food and Drug Administration (SFDA): For example, Announcement No. 155 lists companies such as Beijing Dongxingtang (traditional Chinese medicine tablets) and Shanxi Canon Dahuayu (tablets and pills) and the scope of certification.
2. How to select quality partner factories?
Key indicators need to be validated in an integrated manner:
- Production Line Matching: Verify that the scope of certification covers the required dosage forms (e.g., lyophilised injections, tablets);
- Dynamic compliance records: Focus on the results of recent inspections of enterprises (e.g., Kang Yuan Pharmaceutical 2024 liquid preparation workshop "meets the requirements");
- Verify document integrity: Requirements for process validation programmes (e.g., standards for crushing and tableting parameters for tablet production).
Solutions: Risk Avoidance and Ongoing Compliance
1. What happens if the certification of a partner factory lapses?
Phased emergency response:
- 6 months before expiry of certificate: Urge companies to reapply for certification to avoid production interruptions;
- Failure of sudden inspection: Referring to the case of Anchor Bio, immediately suspend production and rectify the situation, and resume after passing the review (as experienced by Yuliangqing in 2024).
2. How do I ensure that my plant continues to comply with GMP?
Establishment of a triple regulatory mechanism:
- internal audit: Periodic validation of equipment and environment (e.g., cleanroom performance testing) in accordance with GMP requirements;
- Government Flying Inspection Response: Retain fire and environmental protection certificates and verification records (see list of declared materials);
- Supply chain traceabilityFor example, after the freeze-drying workshop of China Resources Shuanghe passed the inspection, the qualification of raw material suppliers needs to be continuously monitored.
A selection of the latest certified companies for 2025 (selected)
| company identification | Scope of Certification | Certification results |
|---|---|---|
| Hebei Orange Well Pharmaceutical | Danqi Shuxin Capsules (Solid Preparation Production Line) | GMP compliant (January 2025) |
| Hebei Ruijitang Traditional Chinese Medicine | Coronary heart suhe capsule (hard capsule production line) | GMP compliant (February 2025) |
| China Resources Shuanghe | Freeze-drying workshop small volume injection S production line | GMP compliant (November 2024) |
| Santen Pharmaceutical (China) | Imported eye drops sub-packaging | National GMP certification (Certificate No. SUJ0628) |
Note: The full directory is availableOfficial Website of Provincial Drug Administrationor the National Drug GMP Certification Bulletin. Enterprises are required to renew their certification every five years, and failure to do so will result in cancellation of the production qualification.
This directory is dynamically updated to May 2025, and the data is derived from public information from national and provincial drug regulatory authorities. When choosing a certified factory, it is recommended to check theirProcess validation documents(e.g., yield balance criteria for tablet production) andRecord of recent flight inspectionsto avoid quality risks.
