Pharmaceutical, GMP, Compliance
GMP Compliance for Pharmaceutical Component Suppliers in China
Pharmaceutical and biotechnology companies sourcing components and packaging from China face GMP obligations that are non-negotiable, and on-site audits remain the primary tool for verifying them.
Pharmaceutical and biotechnology companies face unique challenges when sourcing components and packaging materials from China. GMP (Good Manufacturing Practice) compliance is non-negotiable, and on-site audits are your primary tool for verification.
Critical areas for pharmaceutical supplier audits:
- Contamination control: cleanroom classifications, gowning procedures, environmental monitoring
- Material segregation: proper storage and handling of different product lines to prevent cross-contamination
- Batch records: complete and accurate batch production and control records
- Validation: process validation, cleaning validation, equipment qualification (IQ/OQ/PQ)
- Supplier qualification: raw material supplier approval and ongoing monitoring
- Stability programs: proper stability testing protocols and data documentation
Our quality experts conduct specialized reviews of batch record systems and documentation practices, as well as material control and storage conditions. Those are two critical areas where pharmaceutical GMP violations commonly occur.
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Bob Jordan, Founder & CEO, AsianOPS
25+ years across product design, engineering, sourcing, manufacturing and operations, including Class II and Class III medical device programs and ten years living and working in Shenzhen. Previously PRTM Management Consultants, Cardinal Glass, Guardian Industries and BASF. MBA, University of Virginia Darden School of Business.