Pulse

What an EIR entails and what it means for drug makers

ZOHER T SIHORWALA | Updated on January 09, 2018

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Breaking down the mechanics of an EIR from the US drug regulator, which the local pharma industry increasingly abides by

To get inspected for what one does is considered good. It serves as a much-needed assessment of the purpose or outcome of what you do. And if what you do is a business activity — pharmaceuticals and healthcare, in this case — you are defined as an Establishment. An establishment where you formulate, manufacture, analyse and supply in commerce.

The outcome here is a ‘drug’ , meant to cure diseases and save lives. It goes without saying that the activities of such establishments need surveillance.

A white powder, if not handled well, could be a poison that kills. The same white powder, when handled well, is a drug that saves. And here’s where an EIR (or Establishment Inspection Report) acquires importance.

EIR is the name given by the US Food and Drug Administration (US FDA) for an entire narration of what the FDA investigator / inspector did during the time spent at the establishment (facility), from the stage of introductions till the handover of the inspectional observations (termed as Form FDA 483). The EIR is expected to be a compilation of factual information.

So what tidings does it bring? If an EIR issued after an inspection is completed (without the felt need for an inspectional observation), it is seen as good for the establishment (or the facility) certified for its intended purpose. When the inspection is completed and there are inspectional observations, the type of observations, the number and the areas in which these observations are cited will determine if the EIR brings in good tidings or raises an alarm about something.

If there is something wrong, it may result in any of the following: Warning Letters, Import Alerts, Subpoenas, Consent Decrees and Forced Shutdowns.

Typically, about ten years ago, the response to FDA 483 resulted in an EIR that very clearly mentioned “the facility was found to be acceptable…” In recent times, however, with FDA inspectional observations turning rather more rigorous, FDA 483 responses undergo iterations, culminating in an EIR which is reviewed at various stages at the inspectorate: the investigator’s / inspector’s first copy, the District Office and the Centre (Federal) Office. The FDA 483 response, in conjunction with the EIR, determines whether the “facility (is) found acceptable”. In many recent cases, it is not.

And depending on the classification cited, recommendations are made (in the decreasing order of severity): OAI (Official Action Indicated), VAI (Voluntary Action Indicated), NAI (No Action Indicated). NAI on the EIR is a positive event that means “Facility Acceptable”.

A VAI recommendation implies that the facility needs re-inspection within 12 months at the earliest, but no later than 24 months.

Again, this is a positive development, but the path needs to be navigated under utmost surveillance and with alertness so that the observations cited earlier are not repeated.

An OAI recommendation rings an alarm bell, where a Warning Letter or an Import Alert (read: import ban from the inspected facility) is issued until observations are satisfactorily addressed and the FDA has verified it through an inspection to assure itself of voluntary compliance.

The FDA is supplied with compliance reports, which it has to review and decide upon, while the Establishment goes into a constant mode of remediation with no immediate guarantee that the FDA will be satisfied on the follow-up inspection.

The EIR is a bible of sorts, which the FDA refers to for the given facility when at its premises. Religious books come laden with decrees and commandments, so it’s best to do as it says.

In a nutshell, an EIR eventually brings positive tidings for the facility, which gets reinstated into a state of Good Manufacturing Practices. But the path to be traversed is most often an uphill one, where the alarm bell keeps ringing.

The writer is Senior Vice President and Head of Regulatory Affairs at Wockhardt Limited, Mumbai.Views expressed above are personal.

Published on August 04, 2017

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