GMP audit findings

Responding to GMP audit findings

Receiving notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues.

How and when to respond to the regulator

How and when you respond to the deficiencies is critical as it will impact your compliance rating and the frequency of re-audit.

The deficiencies will be rated as:

  • Critical
  • Major
  • Other

You will be given four weeks to respond to the findings.

Your response should contain a corrective action plan that addresses each deficiency and includes target dates. The lead auditor will notify you if the corrective action plan has been accepted or rejected. You may submit multiple responses. If there are deficiencies that can be easily and quickly addressed, then you can respond to these first and send in later responses that address the deficiencies that need more effort.

Never provide more information than asked as this may provoke more questions and will prolong the close out will be prolonged.

The regulatory will want to see that you are investigating root causes – make sure you include this in your response.

How CiPharma can:

  • Help you use appropriate risk assessment to support your response
  • Consult on what actions need to be taken to address each GMP deficiency
  • Help you write the response, ensuring that you adequately address each deficiency, but don’t provoke more questions.
  • Collect the correct evidence to substantiate the response.
  • Organize a meeting with the regulator to present the response – this may be necessary when there were several major deficiencies

By carefully managing your response, we can help you keep or improve your compliance rating, resulting in longer times between audits.