Receiving a notice of deficiencies after an audit by a regulator or customer 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 a regulatory audit
How and when you respond to audit findings is critical. Whether the audit was to ISO, GCP, GMP or GLP regulatory standards, your response will impact your compliance rating and the frequency of future audits.
The deficiencies will be rated as:
Normally 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 can 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 entire process.
The regulator will want to see that you are investigating the root causes behind your deficiencies- make sure this is included in the response.
How PharmOut can help you prepare your regulatory audit response
- Help you use appropriate risk assessment to support your ISO, GCP, GMP or GLP Audit Response
- Consult on what actions need to be taken to address each deficiency
- Help you write the response, ensuring that you adequately address each deficiency, but don’t provoke more questioning.
- Collect the correct evidence to substantiate the response.
- Organise a meeting with the regulator to present the response – this may be necessary if there are several major deficiencies that need to be addressed.
By carefully managing your response, we can help you keep or improve your compliance rating, resulting in longer times between audits, and most importantly, make safer products.
To learn more
contact us at one of our offices around the world for more information or to request a quote.
If you want to read more about regulatory matters and topics relating to PIC/S, the ICH, FDA, TGA, MHRA or EU and EMA, click on the relevant links.