Facility Inspection

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Facility Inspection 

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP provides comprehensive global regulatory affairs services, leveraging our expertise to navigate market-specific regulations and ensure your products are safe, effective, and compliant with both local and international standards, enabling seamless export and distribution.

 

Facility Inspection: 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.

We provide facility inspection services to comply with the continuous development trend of the GMP standards.  Our specialists possess extensive knowledge from all relevant areas of the industry, including aseptic/sterile manufacturing, biotechnological production, quality assurance, quality control, and product development.

KGMP Factory Inspection 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 Mock Inspection

A mock inspection simulates an official review of your facility and operations to assess compliance with CGMP standards and regulations. Conducting a mock inspection before an on-site inspection by the competent authorities allows you to identify and address weaknesses and nonconformities in your quality system. This approach greatly aids in preparing for your inspection more efficiently and accurately.

• Enhanced compliance: Ensure appropriate compliance with CGMP regulations tailored to your quality systems and business needs.

• Efficiency improvement: Streamline quality processes for increased productivity and reduced costs.

• Risk minimization: Identify potential compliance risks and take corrective measures, minimizing the chances of costly regulatory actions.

• Knowledge sharing: Equip your team with essential expertise to uphold rigorous quality and compliance standards.

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.

U.S. FDA Compliance	Health CANADA Compliance	MFDS Compliance
EU & UK Compliance	ASEAN Compliance	NMPA Compliance

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.

Global expertise	Quality audit	Scientific expertise	Training	1:1 Consulting

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

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