Qualifying suppliers and service providers are 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 reproduceable 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 500 audits and inspection services globally, and the China experts team manages over 30 audits per year.
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.
