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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 19 • One analysis of the APSD from one device • All analyses performed on one day by one ana- lyst • All analyses performed on one day whichever analyst has performed them. It was decided to take the third approach (the most conservative) and define the independent analytical run as a set of analyses performed on a different NGI equipment or a different day. Using this defini- tion, while analyst is an IP factor, a change in analyst on the same day did not result in the analytical run being considered independent as the analyses were considered to occur in too short a time period and thus variation would be stable (e.g., NGI leak rate, humidity). While cupset was not considered an IP factor as it was considered a likely cause of variation, it was varied in a deliberate manner. First, including different levels ensures any variation from cupset Table III: Independent runs for intermediate precision design for Example 2. Condition Factor: Day 1 2 3 4 5 6 NGI N1 N2 N3 N1 N2 N3 N1 N2 N3 N1 N2 N3 N1 N2 N3 N1 N2 N3 Independent run 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Within run Four devices analyzed in each independent run. Analyses within a run were performed by selected combinations of two of the three analysts, using two or three of the five throat/pre-sep combinations and two or three of the five cupsets. One or two devices were analyzed for each combination. NGI is next generation impactor. Condition Factor (between run): Day 4 5 6 NGI N1 N2 N3 N1 N2 N3 N1 N2 N3 Independent run 10 11 12 13 14 15 16 17 18 Factor (within run): Analyst 1 1 3 2 3 1 2 2 2 3 1 2 1 3 1 3 3 1 2 2 2 3 3 T/P 2 5 3 4 3 2 1 2 5 4 1 3 1 5 3 5 1 3 1 2 4 4 2 Cupset C2 C5 C1 C5 C3 C1 C4 C1 C4 C2 C3 C4 C5 C2 C3 C3 C4 C5 C2 C3 C2 C1 C4 # Devices 1 1 2 2 2 2 2 1 1 2 2 2 2 2 2 1 1 2 1 1 2 1 1 NGI is next generation impactor. T/P is throat/pre-sep. Table IV: Full intermediate precision design (including the within run factors) for Example 2. Condition Factor (between run): Day 1 2 3 NGI N1 N2 N3 N1 N2 N3 N1 N2 N3 Independent run 1 2 3 4 5 6 7 8 9 Factor (within run): Analyst 1 2 1 3 2 2 3 1 2 2 3 3 1 1 3 2 3 1 1 3 1 2 T/P 1 4 5 4 3 2 3 4 1 5 2 5 3 4 1 3 2 4 2 1 5 5 Cupset C1 C3 C2 C4 C1 C5 C5 C4 C5 C1 C2 C5 C2 C3 C3 C2 C5 C1 C4 C1 C4 C3 # Devices 2 2 2 2 1 1 2 2 2 2 1 1 1 1 2 2 2 1 1 2 2 2