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A thorough investigation and root cause analysis were conducted upon observing an out-of-specification (OOS) result for content uniformity (CU) in a batch manufactured. The primary issue was attributed to the analytical test method employed, which involves manually transferring the contents of filled capsules into volumetric flasks. A manual transferring practice in the lab is very much prone to accidental spillage resulting in unaccountable content loss, leading to significant variability in CU results. Hypothesis testing confirmed the absence of segregation and demonstrated that a controlled and robust analytical method could deliver consistent CU outcomes, ruling out any issues related to material or process integrity.

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Case Study: OOS Uniformity of Dosage Units (Stratified Samples) for a Capsule Formulation

  • 章节

  • 发表日期：

    2025年

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  • Ajay Babu Pazhayattil,
  • Sanjay Sharma

摘要

A thorough investigation and root cause analysis were conducted upon observing an out-of-specification (OOS) result for content uniformity (CU) in a batch manufactured. The primary issue was attributed to the analytical test method employed, which involves manually transferring the contents of filled capsules into volumetric flasks. A manual transferring practice in the lab is very much prone to accidental spillage resulting in unaccountable content loss, leading to significant variability in CU results. Hypothesis testing confirmed the absence of segregation and demonstrated that a controlled and robust analytical method could deliver consistent CU outcomes, ruling out any issues related to material or process integrity.