Table A.
Sampling scheme for batch assessment
| A | If the number of items in the batch consists of <100 containers, for example, patient packs or boxes, then the minimum number of items to be tested is 10% or four containers, whichever is greater. Draw from the total number of containers and sample ≥50 tablets or capsules. | 1 container per batch delivered. Draw 50 tablets as sample |
| 2 containers per batch delivered. Draw 25 tablets from each container | ||
| 10 containers per batch delivered. Sample 4 containers and draw 13 tablets from each container | ||
| 40 containers per batch delivered. Sample 4 containers only and draw 13 tablets from each item | ||
| 50 containers per batch delivered. Sample 5 containers equivalent to 10% and draw 10 tablets from each container | ||
| 97 containers per batch delivered. Sample 10 containers (about equivalent to 10%) and draw 5 tablets only from each container | ||
| B | If the number of items in the batch consists of >100 but ≤500 containers, for example, patient packs or boxes, then the minimum number of items to be tested is 10 containers. Draw from the total number of containers and sample ≥50 tablets or capsules. | 150 containers per batch delivered. Sample 10 containers and draw 5 tablets from each container |
| 375 containers per batch delivered. Sample 10 containers and draw 5 tablets from each container | ||
| 490 containers per batch delivered. Sample 10 containers and draw 5 tablets from each container | ||
| C | If the number of items in the batch consists of >500 containers, for example, patient packs or boxes, the minimum number of items to be tested are 2% or 20 containers, whichever is less. Draw from the total number of containers and sample ≥50 tablets or capsules. | 540 containers per batch delivered. Sample 11 containers (about 2%) and draw 5 tablets from each container |
| 800 containers per batch delivered. Sample 16 containers (precisely 2%) and draw 3 tablets from each container | ||
| 1000 containers per batch delivered. Sample 20 containers and draw 3 tablets from each container | ||
| 2000 containers per batch delivered. Sample 20 containers and draw 3 tablets from each container | ||
| 9000 containers per batch delivered. Sample 20 containers and draw 3 tablets from each container |