QAS-010 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 263

SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:

Minor defects:

a. Picking: Any tablets having depression of less than 2 mm in size.

b. Small specks: Any tablet with entrapped specks less than 2 mm in size.

c. Porous surface: Unsmooth surface, resulting in loss of shine.

If any defects are found during the check of 32 tablets, then inform the supervisor to separate and
sort. After the corrective action is taken, check as per attached reduced sampling plan.

Action limit
Decide the disposition as per the acceptance plan attached. If rejected, then ask to crush or sort the
portion compressed during that period.
Note down the reading on the control chart for tablet compression.

ACCEPTANCE PLAN - A - SINGLE SAMPLING
NORMAL INSPECTION ANSI/ASQC Z1.4

critical maJor minor5

samPle siZe
code letter

samPle
siZe

aQl
acc.

0.0%
reJ.

aQl
acc.

1.0%
reJ.

aQl
acc.

2.5%
reJ.

lot siZe

G 3201-10,000 32 0 1 1 2 2 37

H 10,001-35,000 50 0 1 1 2 3 4

I 35,001-150,000 80 0 1 2 3 5 6

J 150,001-500,000 80 0 1 2 6 5 6

Send representative samples to QC for final analysis for releasing bulk products for packaging.