Ⅰ. Purpose
This study aims to present guidelines to ensure efficiency in good manufacturing practice(GMP) for manufacturers of medical device. The final product is proposed as follows. The study aims to present a final product for the GMP of small a...
Ⅰ. Purpose
This study aims to present guidelines to ensure efficiency in good manufacturing practice(GMP) for manufacturers of medical device. The final product is proposed as follows. The study aims to present a final product for the GMP of small and medium manufacturers.
Ⅱ. R&D and Methodology
○ Research and analyze domestic/foreign guidelines and guidance on corrective and preventive actions (CAPA) for non-conformance (e.g. harmful elements, etc.).
○ Research and analyze domestic/foreign guidelines, specifications, and guidance regarding fixed installed medical devices.
○ Develop protocol for IQ/OQ/PQ on validation (process, cleaning, clean room, sterilization), and prepare final report.
○ Comparative analysis on product standards for mechanical equipment and medical supplies in place in Korea vs. other countries.
○ Present a standard sample for management review and internal audit.
○ Analyze record management procedures and content of records required by the quality management system.
○ Research and analyze types of service management and recorded cases