F1ANNEX II

Annotations:

2.REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES

2.3.Checking of the average actual contents of the individual prepackages making up a batch

2.3.3.

2.3.3.2.

Criteria for destructive testing

Number in batch

Number in sample

Criteria

Acceptance

Rejection

Whatever the number (≥100)

20

xQn — 0.640smath
x<Qn — 0.640smath