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26 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Best Practices: Part 1 Figure 1 Comparison of Sample and Testing Nomenclature for Analytical Chemistry IUPAC Nomenclature for Sampling (1990) Compendium of Analytical Nomenclature (1997) ASTM E2282-14 (2019) Defining the Test Result of a Test Method WHO guidelines for sampling Technical Report Series, No. 929, (2005) Annex 4 Phase 3: Calculation Protocol Phase 1: Sampling Process Phase 2: Analytical Operations Phase 0: Sampling Plan and Definitions 5_LABORATORY SAMPLE 2_LOT or BATCH Increments 2-1 6 _TEST SAMPLE 7_TEST PORTION 8_TEST SOLUTION 10_ALIQUOT(S) 11_ MEASUREMENT(S) 9_ TREATED SOLUTION 3_PRIMARY or GROSS SAMPLE Composited increments 1_CONSIGNMENT 0_Statistical Sampling Plan • Characteristic 0-1 • Sample 0-2 • Static sampling condition 0-3 • Dynamic sampling condition 0-4 • Specimen 0-5 • Sampling error 0-6 • Homogeneity 0-7 • Sampling uncertainty 0-8 • Unit/item/portion/individual 0-9 • Random sample 0-10 • Representative sample 0-11 • Selective sample 0-12 • Stratified sample 0-13 • Subsample 0-14 • Reserve sample 0-15 • Replicate sample 0-16 4_SECONDARY or AGGREGATED SAMPLE Subsample if required Increments subsampled if required 13_DETERMINATION 7_TEST SPECIMEN or PORTION 11_1 TEST OBSERVATIONS 11_3 TEST DETERMINATION(S) 12_TEST RESULT Single 13_TEST METHOD 6 _TEST UNIT 5_SAMPLE 8&9_TEST SAMPLE UNIT Multiple aliquots 8&9_TEST SAMPLE UNITS Multiple 11_1 TEST OBSERVATIONS 11_3 TEST DETERMINATION(S) 12_TEST RESULT Single or Multiple aliquots 12_TEST RESULT 11_2 OBSERVED VALUE(S) 11_2 OBSERVED VALUE(S) 0_Sampling Plan • Sampling Procedure • Sampling Record • Sample 0-2 • Homogeneity (Uniformity) 0-7 • Sampling uncertainty 0-8 • Sampling Unit 0-9 • Random sample 0-10 • Representative sample 0-11 • Selective sample 0-12 • Subsample 0-14 • Retention sample 0-15 2_ BATCH 6 _FINAL SAMPLE 3_ORIGINAL SAMPLE 1_CONSIGNMENT 4_COMBINED SAMPLE Figure 2. Flow diagram adapted from the 1990 IUPAC proposal (5).