{"id":576,"date":"2026-09-11T11:12:19","date_gmt":"2026-09-11T09:12:19","guid":{"rendered":"https:\/\/www.pqra.gr\/auditing-the-regulatory-affairs-function-the-compliance-area-nobody-audits\/"},"modified":"2026-09-11T11:12:27","modified_gmt":"2026-09-11T09:12:27","slug":"auditing-the-regulatory-affairs-function-the-compliance-area-nobody-audits","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/auditing-the-regulatory-affairs-function-the-compliance-area-nobody-audits\/","title":{"rendered":"Auditing the Regulatory Affairs Function: The Compliance Area Nobody Audits"},"content":{"rendered":"

Manufacturing is audited. Laboratories are audited. Pharmacovigilance is audited because the law requires it. Regulatory affairs — the function that owns the dossier, the commitments, the variations and the deadlines — is very often audited by nobody at all, until a regulator does it for you by finding a product on the market that no longer matches its authorisation.<\/strong><\/p>\n\n

Why the gap exists<\/h2>\n

There is no single regulation mandating an audit of regulatory affairs in the way GVP Module IV mandates pharmacovigilance audits. The obligations are distributed instead: keep the dossier current, implement variations, meet post-authorisation commitments, maintain product information, respond to authority requests within deadline. Because no one instrument names the function, it falls outside most internal audit universes.<\/p>\n

The consequence is predictable. Regulatory teams tend to run on individual knowledge and shared drives, and the risk concentrates in exactly the places nobody checks.<\/p>\n\n

What an audit of the function should test<\/h2>\n

The useful question is not whether procedures exist but whether the authorised product and the marketed product are the same thing. That resolves into several concrete checks:<\/p>\n