Mock Inspection

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Mock Inspection

Partner with KGMP to prepare your quality management systems with the industry's leading experts.

KGMP offers comprehensive GMP/ISO consulting services for the pharmaceutical, medical device, dietary supplement, cosmetics, and related industries. Our expert inspectors, with extensive experience in FDA, EU, and global regulations, provide specialized guidance in planning, implementing, and maintaining robust systems to ensure full GMP/ISO compliance.

 

Mock Inspection: Essential Insights for Your Business

A mock inspection evaluates your quality management systems and processes to ensure regulatory compliance, alignment with best practices, and effective implementation. By identifying non-compliant areas and addressing weaknesses early, you can implement corrective actions, strengthening your quality system before the official inspection by competent authorities.

KGMP inspectors use their extensive audit experience and broad expertise to conduct tailored mock inspections, helping you identify and address non-conformities early. This proactive approach prevents critical non-compliance and ensures efficient, effective preparation for a streamlined certification process.

KGMP Factory Inspection Assistance Service

Mock Inspection: On-site/Remote & Document Inspection → Operation Status Assessment → Observation Report

CAPA Assistance: Investigation & Analysis of Problem → Corrective Action Guidance (Plan, Implementation, Effectiveness Verification) → Effectiveness Verification Assessment

Professional Interpretation: Pre-discussion on Operational Status and Considerations → Audit Participation and Interpretation

483 Letter Response: Observation Analysis → CAPA Direction Guidance → 483 Letter Submission

Key Stage of Mock Inspection

Mock inspection services include the following, though they may vary depending on operational status.

ㆍ      A comprehensive on-site evaluation of the facility's CGMP/ISO management status and guidance on improvement measures

ㆍ      Audit report including observations during mock inspection and improvement measures

ㆍ      Inspections of suppliers and contract manufacturers

ㆍ      Expert assistance from CGMP/ISO specialist

 

Benefits of KGMP's Mock Inspection Service

ㆍ      Early identification and tailored CA plans: Detect potential issues before the actual audit and receive customized CAPA recommendations to address them, ensuring timely and effective corrective actions tailored to your operations' specific needs.

ㆍ      Process improvement: Identify areas for operational enhancements, contributing to overall process efficiency and quality management.

ㆍ      Compliance assurance: Ensure alignment with regulatory standards, reducing the risk of non-compliance.

ㆍ      Enhanced audit preparedness: Simulate real audit conditions to improve your team’s readiness and confidence.

ㆍ      Cost efficiency: Prevent costly re-audits or penalties by addressing issues proactively.

Expert guidance: Benefit from the extensive experience of KGMP inspectors, who provide valuable insights and best practices.

To help you prepare for and respond to factory inspection efficiently and effectively, we provide Mock inspection, Factory inspection (professional interpretation), and CAPA & 483 letter response services.

Remember that different regulations apply in each country.

Contact us today to discover how our Mock inspection services can benefit your business.

KGMP simplifies compliance with complex global regulations.

KGMP supports you in securing global certifications for your facilities, improving product quality management, and facilitating entry into both local and international markets.

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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Our professional, dynamic, and pragmatic team is ready to assist you with information and training.

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