• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Inspection Support

ServicesGlobal ComplianceInspection Support

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 who results 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inspection or for cause inspection, you will face the serious consequences of not passing the inspection or being withdrawn from GMP certification the enterprise when critical defects are identified. 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 support during official inspection for pharmaceutical and medical device enterprises.

Service Advantage

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

advantage

GMP Inspection Support Service Includes but Not Limited to

  • Inspection training: inspectionreadiness
  • Inspection and audit assistance: on-site translation, onsite support
  • Follow up activities and CAPA support