Facility Inspection

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Facility Inspection (Professional Interpretation) 

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. 

 

Facility Inspection (Professional Interpretation): Essential Insights for Your Business

As awareness of the importance of product quality grows, the significance of quality management is increasingly emphasized. Consequently, regulatory authorities in various countries are tightening regulations on quality management systems and conducting more rigorous on-site inspections.

KGMP inspectors, with their extensive knowledge gained from numerous audits, are always on your side. They actively participate in inspections, flexibly interpreting identified non-conformities on-site to either rectify them immediately or develop corrective action plans, ensuring a smooth audit process.

KGMP Factory Inspection  Assistance  Service

Key Stage of Facility Inspection

The inspectors may evaluate a facility's compliance with current good manufacturing practices (CGMP) in the following areas, but are not limited to:

• Employee Hygiene and Training
• Plant Construction and Design
• Cleaning and Sanitation Procedures
• Raw Materials and Ingredients
• Manufacturing Operations

To prepare your facility for unannounced inspections, Mock inspection service includes:

• A comprehensive on-site evaluation of the facility's CGMP management status and guidance on improvement measures
• Audit report including observations during Mock inspection and improvement measures
• Inspections of suppliers and contract manufacturers
• Expert assistance from CGMP Specialist

 

Benefits of KGMP's Facility Inspection (Professional Interpretation) Service

ㆍ      Seamless communication: Ensure smooth communication between auditors and your team, enabling efficient resolution of issues without language barriers or misunderstandings.

ㆍ      Immediate corrective action: By actively participating in the audit, non-conformities can be quickly identified and corrected, minimizing observations in the audit results and improving the overall outcome.

ㆍ      Expert interpretation of non-conformities: Benefit from accurate, real-time interpretation of audit findings, ensuring clear understanding of any non-conformities and how they can be addressed.

ㆍ      Audit process efficiency: Streamline the audit process by facilitating quick, accurate exchanges of information, helping to keep the inspection moving forward without unnecessary interruptions.

ㆍ      Increased audit confidence: With professional interpretation and guidance, your team can confidently address any audit findings, strengthening your position and enhancing compliance.

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 facility inspection services can benefit your business.

KGMP simplifies compliance with complex global regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final products.

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of 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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