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A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.
For pharma companies and regulators to have meaningful discussion on the results of analyses, they should first agree on the meaning of the terms used. As detailed in Part 1 of this paper, the pharmaceutical industry currently does not have a globally agreed nomenclature for sampling and testing.
Inconsistent sampling and testing processes that may result from this lack of standardized practices can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.
In the second part of this paper, the author proposes a simplified overall process flow with associated definitions for pharmaceutical sampling and testing.
Chris Burgess is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.
eBook: Regulatory Sourcebook
When referring to this article, please cite it as C. Burgess, “Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2021).