The EU Directive 2004 27 EEC has been in force since 2004, according to which all active substances in European medicines must be produced according to GMP rules. The responsibility for monitoring lies with the Qualified Persons of the medicinal product manufacturer (MPM), who must check GMP compliance using a supplier audit. Third Party Auditing is an efficient way of reducing the compliance costs for both the API manufacturer and the MPM. 

What we offer

• A highly detailed third party audit report of API manufacturer plants
• High quality due to high requirements on our auditors
  • At least 15 years of experience in the field they conduct the audit (QA or production) in a big pharmaceutical company
  • Having had a senior management position in the pharmaceutical industry
  • At least 5 years of experience as auditors in the API industry (more than 20 days auditing)
  • Regular audit training within ICA (one day per year)
• Monitoring of actions required by the API manufacturer during the validity of the audit report (CAPA plan)
• No conflicts of interest, as ICA does not have any commercial interest in any API supplier

Your benefits

•  Reduced costs and time efforts for API supplier due to lower number of customer audits
• MPM can get a high quality audit report in a short amount of time
• Reduced costs of supplier audits for MPM
• Detailed report which allows Qualified Person to decide regarding GMP compliance
• Our audit reports have been excepted by international public authorities

Available reports

An overview of the available audit reports is provided in the following pdf: Overview Third Party Audit Reports