Audit

Audit services

Services purpose:

Audit services include compliance audit, supplier audit and audit assistance services.

The purpose of compliance audit is to verify whether customer complies with GMP requirements as planned by customer and is to provide improvement suggestions.

The purpose of suppliers audit is to verify whether suppliers comply with regulatory requirements and specialized requirements defined by customer during the 3rd party GMP or ISO audit on customer’s suppliers.

The purpose of audit assistance service is to provide necessary preparation guidance before inspection, on-site inspection solution, CAPA preparation and response after inspection during authorities inspection or customer inspection.

Services contents：

Compliance audit services

• Prepare audit plan
• Review relevant documents
• On-site check compliance
• Prepare inspection report including improvement suggestions
• Explain the inspection report and improvement suggestions to customer.

Supplier audit services

• Get supplier audit requirements of customer.
• Confirm audit dates together with customer and its suppliers.
• Prepare audit plan.
• Review relevant documents(such as process flow chart, Certificate of Analysis(COA), organization chart of supplier）
• Execute on-site audit.
• Prepare audit report.
• Provide audit report draft to customer.
• Communicate audit results with customer.
• Finalize audit report and sign it.
• Distribute approved audit report to customer and supplier.
• Require supplier to provide CAPA in regulated dates.
• Review CAPA provided by supplier.
• Review improvement report provided by supplier.

Audit assistance service

• Guide customer how to prepare audit before audit.
• Provide relevant solution during audit.
• Support to prepare CAPA for observed problems after audit.
• Support to prepare improvement report and submit it to authorities or customer.