SERVICES
NMPA/FDA/EU/PICS/WHO GMP COMPLIANCE
NMPA/FDA/EU/PICS/WHO GMP Compliance
Our compliment of industry experts have successfully worked on NMPA/FDA/EU/PICS/WHO GMP inspections, and assist customers to effectively improve their systems, SME and quality awareness & culture.
• Gap analysis: review the current systems against the target market to assess for gaps and develop CAPA plans and upgrading plans.
• QMS upgrading: guide six systems to upgrade based on the findings identified during gap analysis.
• Hardware renovations: guide facilities and equipment for renovations based on the findings identified during gap analysis.
• Validation guidance: assist in the qualification & validation activities after renovations.
• Process transfer support: support for process transfer, process verification & cleaning validation.
• SME Training: coach and train core personnel and SME to improve the overall quality capabilities.
• Mock audit: perform audit and mock audit after the upgrading.
• Official inspection support: send on-site expert team to support for official inspection to quick response and take actions.
• GMP interpreter: provide GMP interpreter (English, Spanish, Korean) during official inspection.
• CAPA response: assist in CAPA plans and response after the inspection, until finally pass the inspection.
Key words：
NMPA/FDA/EU/PICS/WHO GMP COMPLIANCE
NMPA/FDA/EU/PICS/WHO GMP Compliance
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