QAS-016 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 319

SOP No. QAS-016.00 Effective date: mm/dd/yyyy
Approved by:

Physical characteristics
The QAI will also check the physical characteristics of capsules on an hourly basis on 32 capsules
to ensure that they are not dusty, dented, or ruptured, and that they do not possess any of the defects
mentioned in the chart. If so, the inspector will inform the supervisor for corrective action. After the
corrective action has been taken, check as per the attached reduced sampling plan.
The representative sample for quality control testing will be taken at the end of the process.

acceptance Plan c: single sampling
reduced inspection ansi/asQc Z1.4 level s-4
acceptable Quality level +

sample
size
code
letter

critical major minor

sample aQl 0.0% aQl 1.0% aQl 2.5%

lot size size acc. reJ. acc. reJ. acc. reJ.

G 3201-10,000 13 0 1 0 2 1 3

H 10,001-35,000 20 0 1 0 2 1 4

I 35,001-150,000 32 0 1 1 3 2 5

J 150,001-500,000 32 0 1 1 3 2 5

+ = If the acceptance number has been exceeded but the rejection number has not been
reached, accept the lot reinstate normal inspec t ion.

acceptance Plan a: single sampling
normal inspection ansi/asQc Z1.4 level s-4

sample
size
code
letter

critical major minor

sample aQl 0.0% aQl 1.0% aQl 2.5%

lot size size acc. reJ. acc. reJ. acc. reJ.

G 3201-10,000 32 0 1 1 2 2 3

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 5

35.4 reason for revision
First time issued for the ABC Pharmaceutical Company.