For companies approaching a pre-approval inspection connected with a New Drug Application or Biologics License Application, Dr. Marré recommends starting the preparation process well in advance.
A comprehensive mock inspection conducted approximately three to six months before the anticipated inspection can give the organisation time to identify weaknesses, complete remediation and verify that corrective actions are effective.
The purpose is not to teach people to deliver scripted answers. It is to help them explain their responsibilities accurately and confidently under regulatory scrutiny.
Organisations operating across multiple jurisdictions may also benefit from involving experts with experience of different regulatory authorities. Although the underlying Good Manufacturing Practice principles may be similar, the style, conduct and emphasis of inspections can vary.
A credible mock inspection should test much more than technical compliance. It should give the organisation an opportunity to practise:
• Hosting investigators.
• Managing questions in the front room.
• Receiving and tracking document requests.
• Retrieving and reviewing records in the back room.
• Preparing operators and laboratory analysts for interviews.
• Escorting investigators through operational areas.
• Recording questions, commitments and follow-up items.
• Escalating newly identified issues into the quality system.
Has your organisation tested how the front room, back room, quality team, operators and laboratory personnel work together under inspection conditions?
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