PROCESS VALIDATION OF MEDICAL DEVICES, CONDOMS, CATHETERS, SURGICAL DEVICES

摘要

Many latex dipped products, such as condoms, catheters and surgical gloves are medical devices. As such they have to comply with regulatory requirements, and one of the requirements will be that the manufacturing processes have to be validated. Process validation is a documented procedure that demonstrates a process is capable of consistently delivering a product of the required quality. As such it is a regulatory requirement in the ISO quality management systems 9001 and 13485, as well as many other standards and Good Manufacturing Practice rules and guidelines. However, process validation is more than just a regulatory requirement - properly and sensibly carried out, it is a valuable tool to help manufacturers. It can lead to a much better understanding of the process, better response to quality problems, more accurate trouble-shooting and the optimization of process costs and quality. This paper will set out why process validation is so important, when it should be carried out, and how to conduct it effectively and efficiently. Examples of process validation will also be described to demonstrate the recommended procedures