Annexure-I

SAMPLE SIZES AND ACCEPTANCE CRITERIA FOR TABLET / CAPSULE

INSPECTION
(BULK TABLETS/CAPSULES)

Normal General AQL Inspection Level III – Sample Size and Acceptance Limits:

0.01%* 0.25%* 4.0%*

Batch Size / Lot Sample
Size (Units)* Size*
Accept Reject Accept Reject Accept Reject

10,000 to 35,000 500 0 1 3 4 21 22

35,001 to 150,000 800 0 1 5 6 21 22

150,001 to 500,000 1250 0 1 7 8 21 22

500,001and OVER 2000 0 1 10 11 21 22

* Reference: ANSI/ASQ Z1.4-2008, Single Normal Procedure, Table – II, General

Level – III.
Tightened General AQL Inspection Level III – Sample Size and Acceptance Limits:

0.01%* 0.25%* 4.0%*

Batch Size
Sample
(Units)*
Size* Accept Reject Accept Reject Accept Reject

10,000 to 35,000 500 0 1 2 3 18 19

35,001 to 150,000 800 0 1 3 4 18 19

150,001 to 500,000 1250 0 1 5 6 18 19

500,001and OVER 2000 0 1 8 9 18 19

* Reference: ANSI/ASQ Z1.4-2008, Single Normal Procedure, Table – II, General

Level – III.