Validation of analytical methods in compliance with good manufacturing practice: a practical approach

Table 2 LAL test precision

Sample number	Experiment 1 (EU/ml)	Experiment 2 (EU/ml)	Experiment 3 (EU/ml)
1	<0.0050	<0.0050	<0.0050
2	<0.0050	<0.0050	<0.0050
3	<0.2500	<0.2500	<0.2500
4	<0.4000	<0.4000	<0.4000
5	<0.0500	<0.0500	<0.0500
6	<0.2500	<0.2500	<0.2500
7	<0.4000	<0.4000	<0.4000
8	<0.0500	<0.0500	<0.0500
9	<0.2500	<0.2500	<0.2500
10	<0.4000	<0.4000	<0.4000
11	<0.0500	<0.0500	<0.0500
12	<0.2500	<0.2500	<0.2500
13	<0.4000	<0.4000	<0.4000
14	<0.0050	<0.0050	<0.0050
15	<0.0050	<0.0050	<0.0050
16	<0.0050	<0.0050	0.0627
17	<0.0050	<0.0050	<0.0050
18	0.0667	0.0558	<0.0500
19	<0.2500	<0.2500	<0.2500
20	0.4095	<0.4000	<0.4000
21	<0.0500	<0.0500	0.065
22	<0.2500	<0.2500	<0.2500
23	<0.4000	<0.4000	<0.4000

The LAL test was performed three times under the same operating conditions by the QC manager on our CTPs and supernatants. The test was repeatable. Endotoxin concentrations in all samples (EU/ml) were ≤ 0.5 EU/ml as requested by the Food and Drug Administration. Samples analysed are given in Table 1. Samples: 1 = pyrogen free water (negative control); 2–10 = supernatants with FBS; 11–13 = supernatants with albumin; 14–17 = CTPs; 18–23 = supernatants with HS.

ISSN: 1479-5876