Essentials for Failure investigations in Pharmaceuticals

Essentials for Failure investigations in Pharmaceuticals

In pharmaceutical industry failure investigations are critical and hard to manage, as it evokes regulatory attention. In recent years regulatory agencies are forcing to organizations to change their failure investigation methodologies.

Remember! “A good failure investigation gives an opportunity to improve the quality of the product”

Inadequacies in failure investigation can invite regulatory actions. It is noteworthy to evaluate the recent FDA warning letters to the pharmaceutical manufactures. Most of these letters figure out the inadequacies in failure investigations 

Do’s and Don’ts of failure investigations detailed below.

Do’s

Take every investigation seriously.

The investigation should be thorough, timely, unbiased, well-documented, and scientifically sound.

Subject matter experts from relevant areas to be included in investigation team and the team should lead by quality unit.

A failure investigation does require a documented review of manufacturing performance (e.g., deviations/discrepancy investigations, maintenance, and process control data) or quality data.

Historical data (trend) to be evaluated as a part of failure investigation.

Extend the investigation to other batches (i.e. assess passing batches to determine if any of these same alleged conditions were present).

Risks to be considered and impact assessment of the affected batch/product to be performed as a part of investigation.

Initiate a field alert/recall, if necessary.

Notify the regulatory agencies in case of serious quality problems such as: Faulty manufacture, Product deterioration, Counterfeiting etc.

If required additional laboratory testing/experiments to be performed.

Investigate to root cause where possible

Take necessary CAPA's for the identified root cause.

Dont’s

Do not perform any informal investigation.

Do not take the easy road and stop at the quick fix.

Do not withhold failure information from the regulatory agency.