Pharmaceutical Technology - September 2021


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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 23 Best Practices: Part 1 C onsistent sampling and testing nomenclature is crit- ical for data integrity and compliance with specifi- cations and regulatory standards. Currently, there is a lack of agreement between the major sources of guidance both within the pharmaceutical industry and between other regulated sectors. The following is a review of available analytical nomen- clature, what individual steps should be called, and terms in the process flows; it is not a discussion on how to perform the sampling and testing processes themselves. The topic of how to perform sampling is well documented, albeit primarily for geochemical purposes (1–3). Part two of this paper proposes a simplified approach for sampling and testing nomenclature. "It all depends on what you mean by …" was the catch- phrase of British philosopher C. E. M. Joad, before answering any question. No meaningful discussion on the analytical results of analyses can be had without a prior agreement on the meaning of the terms used. Despite this self-evident fact, there is currently no globally agreed nomenclature of sam- pling and testing. Attempts have been made to harmonize sampling and testing nomenclature within analytical chemistry by the In- ternational Union of Pure and Applied Chemistry (IUPAC) in 1990 (4) and confirmed in 1997 (5); the American Society for Testing of Materials (ASTM) in 2003, revised in 2014 and reapproved in 2019 (6); and the World Health Organization (WHO) sampling guidelines in 2005 (7). In addition to these sources, there are other definitions, often conf licting, within current good manufacturing prac- tices (cGMPs) and pharmacopoeias. It is important to under- stand that sampling is always an error-generating process and that although the reportable value may be dependent upon the selected analytical procedure, it will always be dependent upon the sampling process (8). IUPAC 's nomenclature for sampling and testing The 1990 IUPAC document explicitly targeted the sam- pling process because of various uses and abuses of the word Chris Burgess is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK. IPOPBA - STOCK.ADOBE.COM Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Review of Current Practices Chris Burgess Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality. A review of regulatory and compendial standards reveals the scope of the problem.

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