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

Services

3rd Party Audit

ServicesGlobal Compliance3rd Party Audit

Qualifying suppliers and service providers are the key and mandatory of the GMP regulations and guidelines. For critical materials, products or services, to purely have the documentation provided by the suppliers or service providers is definitely not sufficient. Supplier audit is required to comprehensively inspect their quality managing capabilities. In addition to the initial qualification audit, re-audits must be assessed and executed regularly to ensure their continuous capabilities for providing reproducible products and services.

gempex auditors can provide comprehensive qualification audit (initial audit), routine compliance audit (repeated audit), special circumstance audit (for cause audit), audit improvement status (follow up audit), etc.  The whole audit process is in compliance with the GMP requirements and guidelines as well as customer internal management requirements. What’s more, gempex also develops remote audit service oriented to the global situation in recent years.

gempex has serviced over 500 audits and inspection services globally, and the China experts team manages over 30 audits per year.

Service Advantage

International and Multi-Type Audits: Multinational audit, including Asia, Europe, North America and other regions covering a wide range of products and services

The high-quality and one-step services: Covering three parties’ coordination, audit execution, report preparation and CAPA review

International expert teams and international compliance: The experts with diverse compliance inspect experience in biological, sterile, API and so on.

advantage

The Audit Services Include

  • Materials and packages suppliers: starting materials, raw materials, excipients, packaging materials, etc.
  • API factories: sterile API, non-sterile API, biological drug substance (DS)
  • Pharmaceutical factories: biotechnology, chemical drugs, injections, oral solid,sterile process products
  • ATMP: cell therapy and gene therapy products
  • Service providers: domestic and international CDMO/CMO, contracted laboratory

Service Workflow