China GMP Third Party Supplier Audit Services

At Regucy Advisory Group, we provide specialized consulting services tailored to ensure compliance with GMP regulatory standards, including China NMPA, FDA, EMA or other requested country-specific regulations. Our in-depth expertise supports manufacturers in meeting the rigorous demands of the regulatory environment, safeguarding product quality and compliance.

Gap Analysis & Auditing Services

Our experienced auditors offer a comprehensive analysis of your manufacturing operations based on China NMPA or international HA GMP standards. We identify potential deficiencies and provide actionable recommendations to close any compliance gaps.

• China-Specific Third-Party Audits
  We conduct independent audits to help manufacturers align with GMP standards, ensuring full compliance in the following areas:

  • Confirmation of audit objectives, scope, and schedule.

  • On-site evaluation of critical systems, including:

    • Quality System

    • Laboratory System

    • Manufacturing System

    • Facility and Equipment System

    • Materials System

    • Packaging and Labeling System

  • Detailed post-audit reports, outlining findings and providing necessary improvements to meet GMP standards.

  • Evaluation of the manufacturing process consistency, ensuring alignment with the application dossier submitted to health authorities.

Mock Audits

We provide mock audits that replicate the inspection process from global health authorities including China NMPA, FDA, EMA, and country-specific regulations, ensuring your site is fully prepared for official inspections.

• Simulated Inspections
  Our mock audits mimic the specific characteristics of HA inspections, identifying gaps in compliance and offering recommendations to ensure a smooth regulatory audit.

Support During Official Inspections

Regucy Advisory Group offers expert support throughout the entire inspection process, from preparation to the final audit, ensuring you meet all GMP requirements.

• Pre-Inspection Support

  • Comprehensive GMP Training to ensure your team is well-prepared.

  • Pharmacopeia Training, to familiarize your staff with essential regulatory guidelines.

  • Pre-audit planning, including inspection preparation and skills training to navigate the official process confidently.

  • Arrangement of the workflow and venue ahead of the health authority inspection to ensure a seamless experience.

  • On-site GMP technical support during the inspection to answer regulatory queries and support compliance.

  • Professional GMP translation services to facilitate smooth communication with bilingual inspectors.

  • Non-technical assistance, such as coordinating logistics for HA inspectors during the inspection process.

CAPA Consulting

After an inspection, we provide consulting services to help companies implement effective Corrective and Preventive Actions (CAPA), tailored to GMP standards.

• CAPA Strategy

  • Guidance on CAPA methodology and strategy, ensuring compliance with regulatory expectations.

  • Review and validation of your CAPA report to ensure it meets GMP standards.

  • Professional translation services for CAPA documentation, ensuring clarity and precision in regulatory submissions.