Pharmaceutical Technology - September 2021


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34 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Best Practices: Part 2 N o meaningful discussion on the results of analy- ses can be had without a prior agreement on the meaning of the terms used. Despite this self-ev- ident fact, there is currently no globally agreed nomenclature of sampling and testing in the pharmaceutical industry. This lack of agreement is now more apparent than ever when discussing data integrity of analysis and testing. In Part 1 of this paper (1), a review and critique were made of currently available sampling and testing nomenclatures within analytical chemistry. The purpose of this second part is to propose a simplified overall process f low with associ- ated definitions for pharmaceutical sampling and testing. As was described in the first part of this paper (1), pub- lished guidelines for sampling are overly complex, contra- dictory, inconsistent, and have differences in coverage. This paper proposes a simple but scalable end-to-end, four-phase process (Phases 0 to 3) shown diagrammatically in Figure 1 that features the following: • An overall statistical sample plan (SSP), designed to meet company needs while adhering to sound sam- pling principles • A material-specific sampling process in compliance with the SSP with three sub-processes (a sampling pro- cedure, a sampling protocol, and a sampling record) • An analytical process for a specific sampled material with three sub-processes (analytical operations, a cal- culation protocol, and an analytical record). High-level structure for sampling (Phase 0 and Phase 1) The purpose of analysis is to predict the value of a characteris- tic of a population (material consignment, lot, or batch) based upon a sample. This paper does not concern itself with technical aspects of the theory and best practices of sampling, which are well documented elsewhere albeit primarily for geochemical purposes (2–5). While there are large discrepancies in nomenclature, there is a general consensus that there are two distinct and independent generic processes involved; namely sampling and testing. The generic sampling process requires an input from a statistical Chris Burgess is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, United Kingdom. IPOPBA - STOCK.ADOBE.COM Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach Chris Burgess Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality. A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

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