QAS-026 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 394

45.5 attachment forms

abc Pharmaceutical comPany

SOP No.: QAS-026.00

Issued date:

Annexure I

A. Normal Inspection—Single Sampling Plan
(Based on Mil-Std 105 E. Table 11-A)

aQl 0.65

code
(special level)
(s-1)

sample size
( n )
(unit strip)

lot size
unit strip

ac
(unit Pocket)

rej
(unit Pocket)

2-8 A 2 0 1

9-15 A 2 0 1

16-25 A 2 0 1

26-50 A 2 0 1

51-90 B 3 0 1

91-150 B 3 0 1

151-280 B 3 0 1

281-500 B 3 0 1

501-1200 C 5 0 1

1201-3200 C 5 0 1

3201-10,000 C 5 0 1

10,001-35,000 C 5 0 1

35,001-150,000 D 8 0 1