QAS-025 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 385

SOP No. QAS-025.00 Effective date: mm/dd/yyyy
Approved by:
3. Once this starting point is picked, movement in any direction will give a random sample
of numbers.
Example:
a. A lot of 45 containers numbered 01 to 45. A random sample of 7 is desired.
b. Suppose the point selected is number 15 (Attachment I (page 1 of 2), 2nd column,
9th row).
c. If we move down, the samples selected would be numbers 19, 01, 24, 31, 12, 42. (We
could also move up or across.)
4. When a number encountered in the table of random numbers is greater than the total
number of containers in the lot, this number should be discarded and the next number
taken.
5. When a number encountered is a duplication of a number already chosen, the duplicate
should be discarded and the next number taken.
44.4 attachments
Attachment I: Table of random numbers. Lot size up to 1-100 containers (two pages)
Attachment II: Table of random numbers. Lot size up to 101-1000 containers (two pages)
44.5 reason for revision
First time issued for the ABC Pharmaceutical Company.