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Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.
In pharma applications, consistent sampling and testing nomenclature is critical for data integrity and compliance with specifications and regulatory standards. Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.
Guidance documents within the pharma industry and other regulated sectors, however, offer conflicting information. This review of regulatory and compendial standards reveals the scope of the problem.
This article provides a review of available analytical nomenclature, recommended naming for individual steps, and terms used in the process flows. Part two of this paper proposes a simplified approach for sampling and testing nomenclature.
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 Review of Current Practices," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2021).