As regular inspection is a key requirement of the GxP regulations and guidelines, enterprises such as pharmaceutical and medical devices are subject to official inspections, and the results of which are made public. Whether it is GMP inspection, unannounced inspection or for cause inspection, you will face the serious consequences of not passing the inspection or being withdrawn from GMP certification the enterprise when seriously defective observed. Even when the GMP system of an enterprise has reached a high level, the improper introduction and answer of the inspector due to lack of experience may still lead to unnecessary findings.
gempex is familiar with the requirements of official inspection, has accumulated years of practical experience, and can provide inspection guidance, audit assistance and support, on-site official inspection support for pharmaceutical and medical device enterprises.
Provide strategic support for inspection guidance
International professional team, familiar with international regulatory requirements
One-stop solution: Responses to findings, replies to authorities, definition of CAPAs, implementation and validation
