GMP, Pharma

Root Cause Analysis for Drugmakers

Hi Everyone

Whenever regulatory authorities anywhere in the world perform an audit of a drug manufacturer, one of their most frequent findings remains the inadequate performance of the investigation of deviations.

Authorities expect stakeholders will carefully investigate deviations to identify non-compliance, intervene and then evaluate the effectiveness of that intervention. Without adequate investigation and root cause analysis (RCA), those stakeholders cannot effectively identify and design successful interventions. In fact, organizations waste millions of dollars every year on ineffective interventions.

A tool such as RCA uses a defined critical analysis approach in evaluating the reason for a deviation or non-conformance.

RCA techniques include brain storming, the “5 whys” and the “fishbone diagram.” Any and all may be used to explore and further examine the causes behind an event. Firms may then use the resulting analysis to identify areas for change, as well as any recommendations and solutions that aim to minimize the likelihood of an event repeating in the future.

Some organizations go so far as to create a corrective and preventive action (CAPA) for every event, although it is not always necessary.

A firm’s primary goals in investigating an incident should include both discovering its cause and ensuring it does not reoccur.

Regulatory authorities place a high value on RCA and CAPA. Indeed, a large number of FDA observations cite inadequate RCA, ineffective investigation and inappropriate CAPA.

When a deviation occurs, whether in the pharmaceutical or any other industry, the responsible firm must undertake an investigation to determine what went wrong and what damage, if any, the product might have suffered. The investigation process should include some specific steps. These include:

  • Notification of the appropriate stakeholders;
  • Containment action;
  • Classification of the event;
  • Decision to investigate;
  • Determination of the root cause or RCA; and
  • Review and approval process.

The effectiveness of the CAPA taken by an organisation marks another key step in the overall RCA. By monitoring the CAPA, an investigative team can determine whether it truly identified an incident’s root cause and then applied the “appropriate fix.”


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