Published on Aug 13, 2025

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Deviation management is an important and integral tool of a pharmaceutical quality system. Deviations may be detected during any stage of the product lifecycle, and it is important to document and handle them appropriately. Pharmaceutical manufacturing processes for example are a complex interaction between material, machine, environment and humans. Material quality could fail the specification, machines can break down, the environment may not be suitable at times and people can make mistakes. However, every pharmaceutical company must have a system in place to identify and assess the impact of these deviations on product quality and process robustness.

What are the critical steps in managing deviations

Deviation management procedure should be robust to ensure that every deviation is handled timely, consistently and adequately. Following are the critical steps involved in managing pharmaceutical deviations.

Deviation detection: A deviation can be detected by anyone and anytime, directly or indirectly, by an internal or external employee. It is always important to communicate the detection of a deviation in a timely fashion and using the adequate communication channels. The step also involves initial classification, evaluation and recording of the deviation in an appropriate system, most of the time is an electronic quality management system. The step could also involve instantaneous correction, or any other action required to mitigate immediate risk to product quality or impact to patients.
Investigation and root cause identification: Deviations should be investigated to determine whether there is any potential quality, regulatory or patient impact. The intent of the investigation is to ensure continuous quality improvement and minimise defects by identifying the most probable root cause of deviation. Various root cause analysis tools are used to determine the true or most probable root cause.
CAPA determination and implementation: Key to any deviation handling is the determination of an effective CAPA (corrective and preventive actions). Once the investigation is complete and the root cause is identified, this step involves correcting the deviation and preventing their recurrence. Corrective actions are taken to prevent the reoccurrence of deviation while preventive actions are taken to prevent the recurrence of a similar deviation in the future. CAPA is considered a tool for quality system improvement and should be always checked for its effectiveness to ensure that significant issues do not recur.
Periodic review and trend analysis: All deviation investigations should be monitored and trended for recurrences of root causes at least annually to evaluate whether further action is required. Recurring events of similar root causes could indicate that the original CAPA was not effective and require further investigation.

Common consequences of inadequate handling of deviations

Neglecting, ignoring or not properly investigating a deviation can be damaging to not only product and pharmaceutical business but can negatively impact the lives of patients directly or indirectly.

Product quality: Ignoring minor deviations or inadequate investigation of deviations during manufacturing can lead to products which are meeting the quality specifications.
Regulatory non-compliance: During inspections, the regulatory authorities may issue observations of inadequate investigations, CAPA or root cause of deviations. These observations if not addressed to the satisfaction of regulatory agencies can result in further regulatory action, regulatory filings, authorisations and certifications.
Financial impact: Deviations impacting product, process, machine or method if not handled promptly and efficiently can lead to major financial loss for the company. Pharmaceutical companies recall products worth millions of dollars from the market because deviations are not detected or investigated properly.
Reputation & business loss: Regulatory or legal actions arising out of product defects and non-compliance can lead to loss of reputation and business.

Deviation management plays vital role in maintaining regulatory compliance, product quality and supports the continuous quality improvement. By adequately addressing deviations, implementing effective CAPA and avoiding the recurrence, pharmaceutical companies can maximise operational efficiencies and benefits across the product lifecycle. For pharmaceutical industry, patient safety is paramount, and effective deviation management is integral to achieving this goal.

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