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1 August 2011

What are the Expectations for in-house or Third Party Audits of API Manufacturers?

The expectations with regard to audits at API manufactures are currently intensively discussed in industry and authorities. Manufacturers of medicinal products are required by EU Directive 2001/83 to regularly audit all their API manufactures to make sure that all APIs are manufactured according to EU GMP Part II (ICH Q7). The audits can be performed by own personnel or by so called “Third Parties” (external organisations).

However, there are a number of questions about how to comply in detail:

  • Is it e.g. necessary to perform product oriented audits at the API manufacturers or are system based inspections acceptable?
  • What are the qualification requirements for auditors?
  • How to avoid a conflict of interest and auditor independence (especially when using Third Parties)?
  • How many days for the Audit are recommended?
  • Etc.

The European QP Association has developed a short check list intended to help QPs to verify the basic audit expectation.

For further information about this topic please also see:
European Medicine Agency (EMA) Q&A Statement on the use of Third Party Auditors
The Danish Medicines Agency’s expectations for audits of API manufacturers