A Deviation in the pharmaceutical industry is defined as any measurable differences between an observed value and an expected or normal value for a process or product condition, or a departure from a documented standard or procedure. Deviations can occur at any point during a product’s lifecycle, from testing and manufacturing to final product acceptance and post-market surveillance. They can be triggered by various factors, such as equipment breakdowns, human errors, or changes in raw materials.
What are the key points about deviations in the pharmaceutical industry?
They need to be documented for compliance with Good Manufacturing Practices (GMP) and continuous improvement.
The FDA requires thorough investigation of deviations, with conclusions and follow-up documented.
Deviations are classified as critical, major or minor based on their potential impact on product quality and safety.
What are the different types of deviations in pharma?
In the pharmaceutical industry, deviations are categorized into several types based on their occurrence, impact, and nature.
Here are the different types of deviations:
Planned Deviations: Planned deviations are pre-approved, temporary changes to a standard procedure to avoid an undesirable situation without affecting product quality.
Example: Changing batch size due to raw material unavailability, using Water for Injection (WFI) instead of purified water for equipment cleaning.
Unplanned Deviations: Unplanned deviations occur unexpectedly and are not approved before execution.
Example: Equipment breakdown due to power supply interruption, human errors, or utility failures.
AmpleLogic’s Deviation Management Software
