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Question of the Week

What has to be taken into account for third-party audits at API manufacturers?

Third-party audits can be used as an alternative to internal audits. Numerous providers who offer these audits are available on the market. They sometimes differ markedly from one another with regard to meeting the requirements (qualification and independence of the auditors). The resulting audit quality varies accordingly. When audits are outsourced to providers of third-party audits, these providers must be properly qualified in compliance with the requirements of the organisation’s own
QM system and in conformity with Chapter 7 of the EU-GMP Guide (“Outsourced activities”, effective since 31 January 2013).

[GMP MANUAL, Chapter 21.E.4]

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