We provide professional, independent third-party GMP audit services to ensure supply chain compliance, help companies mitigate procurement risks, and support informed purchasing decisions.

1. Regional Audit Support:

EU/US Markets: Audit API, excipient, and drug product suppliers per FDA 21 CFR Part 211/EU GMP to ensure international compliance.

Emerging Markets: Assess supplier compliance for WHO-PQ and PIC/S members (e.g., Japan PMDA, Korea MFDS).

Internal Audits: Conduct GMP audits for in-house facilities and CMO/CDMO partners to enhance QMS.

2. Audit Focus Areas:

Data integrity (ALCOA+)

Cross-contamination controls (EMA Annex 1)

Supplier quality agreement implementation

Deviation, change, and CAPA management effectiveness

1. International Team: Led by senior audit experts to accurately identify compliance risks.

2. Efficient Response: Rapid delivery of bilingual (Chinese/English) audit reports to ensure timely decision-making.

1. Multinational pharmaceutical supply chain management departments

2. API/excipient/packaging material manufacturers requiring customer audit compliance

3. MAH companies (quality evaluation of contract manufacturing)

4. Healthcare investment institutions (M&A due diligence)