Discussion Topic: PRE-AUDIT PREPARATIONS FOR INDIAN PHARMA COMPANIES

The thing that concerns most Pharma organisations, by far, is an FDA Inspection or Audit. Inspectors arrive without much warning, and suddenly your entire operation is put under the scanner, and everyone and everything within your organisation gets evaluated. The implications of that evaluation are hugely significant, of course. And so often, an audit can result in an official Warning Letter from the FDA, and even force companies to shut down operations entirely.

 

That is clearly the worst case scenario. But with a little bit of planning and foresight, there are many ways for organisations in this sector to be prepared for Auditors 24x7, all year round. Being proactive is always a better option than being reactive after a Warning Letter has officially been filed.

Over the course of the coming weeks, we are going to be delving deep into the mechanisms of FDA Audits — preparation, behaviour of employees during the audit, post-audit responses and reactions, etc.

By the end, we hope to have changed the industry mindset enough that there is real change — resulting in many more Pharma companies in India not just meeting compliance regulations, but far exceeding them.

To begin with, let’s take a look at what an organisation can do to always stay prepared for an FDA auditor’s visit.

Identify Key Employees

When the auditor arrives, it’s imperative that the employees immediately swing into action. For this to be an effective exercise, the key employees should have been identified in advance, so that everyone’s responsibilities are clearly understood and defined. Key Employee roles include Director of Quality, Regulatory Director, Quality Assurance Manager or Production Manager. Besides these key roles, there should be one role assigned to a single employee who will play the part of the main liaison or company representative to the FDA Inspector.

It is also important to assign backup roles in case the key employees are unavailable at the time of inspection.

Educate these Key Employees

Once the responsibilities of the Key Employees have been made clear to them, it is important that they educate themselves on the various aspects of an FDA audit. They need to be aware of the various existing 483s (readily available online), to get an idea of the kinds of issues that are being identified and reported by Inspectors.

It is also prudent to run regular mock drills for Audits and Inspections, just so the employees are well trained in handling the stress that comes with such an event.

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