What Are the Required Validation and Verification for Sterile Medical Devices Production?

Sterile medical devices, which have direct or indirect contact with the human blood system or human tissue, play a critical role in the patients’ safety.  More stringent requirements regarding the production process control and quality control are required by China GMP. The following are some examples of validation and verification items, which may help you to plan/review your QMS to compliance with China GMP. It is not a complete checklist. Please contact us if you have any questions or concerns.

Aspect	Verification/Validation Item
Institutions and Personnel	Validation and Verification of Personnel Gowning and Hygiene Procedure
	Validation and Verification of Initial Bioburden of Human Hands and Products
	Validation and Verification of Gown Cleaning Procedure
	Validation and Verification of disinfectants
Plant and facilities	Validation and Verification of the Maximum Occupancy in the Clean Room
	Validation and Verification of Clean Room Environment
	Validation and Verification of Clean Room Disinfection Procedure
	Validation and Verification of Water System
	Validation and Verification of Compressed Air System
Equipment	Validation and Verification of Key Production and Testing Equipment
	Validation and Verification of Equipment and Tools Cleaning Procedure
Design and Development	Product Design Review, Confirmation and Transferring
Production management	Validation and Verification of Aseptic Sealing Procedure
	Validation and Verification of the Shelf Life of products, Materials and Self-prepared Reagents
	Validation and Verification of Critical Processes and Special Processes
	Validation and Verification of Cleaning and Disinfection Procedure
	Validation and Verification of Cleaning Process of Materials and Products
Quality Control	Validation and Verification of Testing Procedure for Initial Bioburden of Products and Materials
	Validation and Verification of Sterility Test Procedure
	Validation and Verification of Microbiological Test Procedure
	Validation and Verification of Ethylene Oxide Sterilization Process