3rd Party Audit for GMP compliance

gempex provides 3rd Party Audit services on GMP compliance to many customers every year, many of whom are biopharmaceutical companies. Recently, gempex has conducted 3rd Party Audit at three biotech companies located in South Korea, Heilongjiang and Shanghai respectively.

Scope of 3rd Party Audit services

  • In-depth inspection at an aseptic process plant in South Korea and determination if it meets the requirements for Phase III clinical trials.
  • Pre-inspection at an aseptic process plant in Heilongjiang on the purpose of successfully applying for EU Authority inspection, as well as preparing the gap analysis report to the authority.
  • Pre-inspection at a biomolecule plant in Shanghai to determine if it meets the requirements for clinical samples of the European and the US markets 

Through years of practice, gempex has accumulated sufficient experience and provides in-depth technical expertise and absolutely secure knowledge of the respective, relevant rules. We are familiar with official inspections and audits so as to provide customers with assistance for passing official inspections focusing on international GMP requirement. gempex also conducts 3rd Party Audits at suppliers or service providers.