Audit Contingency & Form 483

We have quite often heard about the contingency plan for an Audit, especially when it is a regulatory inspection, like by the US FDA (United States Food and Drug Administration) or MHRA (Medicines and healthcare product regulatory agency).

Claris recently underwent a regulatory inspection by the US FDA and was given the green flag with no observations reported.

With compliance being the utmost priority for every inspection, it has become essential for every Marketing Authorization Holder (MAH) to have an audit response team, which would capable and qualified to understand all the norms and requisites for a regulatory visit.

Over the past several years it has been observed that FDA has been proactive in constantly monitoring ADR and compliance which has led it’s issuing of ‘Form 483 warning letters and citations’ to many companies.

Form 483 refers to the 21 United States Code (USC) part 374 which authorizes US FDA to conduct ‘Inspectional observation’ and ‘Factory Inspection’, it is therefore ideal that every MAH should have an SOP on inspection readiness for both regular and targeted audits.

We at Think I are also engaged in providing training in Quality Assurance, Audits and Inspection. Our team comprises of seasoned subject matter experts from pharmacovigilance Industry.

We provide Pharmacovigilance safety databse solutions using cloud based technology which are not only cost effective and user friendly but also fully validated meeting all the compliance checkpoints facilitating quick, easy import, entry and electronic submissions of adverse event.

For more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in or simply visit www.thinki.in

Joseph Mathew

Sr. Manager-Think I

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