GMP Audits for Chinese Pharma, Food & Cosmetic Factories
Good Manufacturing Practice (GMP) is a core requirement for regulated industries. Angelstar Consulting delivers comprehensive GMP audits for Chinese enterprises in the pharmaceutical, food, and cosmetic sectors, focusing on production environment, process control, and quality management. Our third-party audits help you comply with international GMP standards, ensure product quality, and meet market access requirements.
How do we carry out our GMP good manufacturing practice audit services for Chinese pharma, food and cosmetic factories?
1： GMP Standard Alignment & Industry-Specific Planning
Before the official GMP audit, our team aligns your production processes with industry-specific GMP standards (pharmaceutical GMP, food GMP, cosmetic GMP) and national/international regulations. We define the audit scope based on your industry (e.g., pharmaceutical production, food processing), and review your GMP documents, including production process validation records, quality control procedures, and employee training records, to identify potential compliance gaps.
2： On-Site GMP Audit & Production Process Verification
On-site audits focus on core GMP requirements: production environment (cleanliness and sterility), personnel hygiene (employee health management and training), raw material control (supplier certification and testing), production process control (batch number management and process validation), and finished product testing (quality and safety testing). Our auditors inspect your production facilities for compliance with GMP requirements, verify production process records and testing reports, and interview GMP personnel to assess their operational awareness.
3： GMP Compliance Report & Rectification Guidance
A detailed GMP audit report is issued within 3 working days, including GMP assessment results, non-conformity identification (e.g., lack of process validation, incomplete testing records), and targeted rectification solutions. Our experts help you optimize your GMP system, such as implementing a standardized production process validation procedure or enhancing quality control measures. We conduct a re-audit to ensure full compliance with industry-specific GMP standards.
4： Long-Term GMP Compliance & Regulatory Updates
We offer ongoing support to maintain GMP compliance: updating your GMP system based on the latest industry regulations, providing GMP training for your staff, and assisting in responding to regulatory and buyer GMP audit inquiries. Our services help Chinese enterprises in regulated industries (pharmaceuticals, food, cosmetics) ensure product quality, meet market access requirements, and avoid regulatory penalties.
GMP Audits: Third-party good manufacturing practice verification for Chinese enterprises in pharma, food, and cosmetic industries.