QAS-020 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 357

SOP No. QAS-020.00 Effective date: mm/dd/yyyy
Approved by:
• Temperature uniformity validation records for freeze dryer
• Line qualiication by media ill
j. Cleaning validation
39.4.7 o ther d ocumentS
a. If the submission includes a bioavailability study, the packing slip or letter which accom-
panied the sample(s) submitted to the bioavailability testing laboratory will be copied.
b. For submissions with bioavailability studies, the following must be reviewed:
• The lot number on the packing slip or letter which accompanied the sample(s) submit-
ted to the bioavailability testing laboratory should be identical to the lot number entered
in the bioavailability report.
• The date the sample(s) were sent to the bioavailability testing laboratory should be
consistent with the manufacturing and testing dates for the batch.
• If the report includes a physical description of the product, it should be consistent with
the actual description.
c. The actual packaging components used in the stability study should be consistent with that
described in the submission, and those entered on the stability report.
d. Trends for viable count, nonviable count, surface monitoring, and personnel monitoring.
e. Sterilization information and data.
f. Approved drawings for facility, water plant and lines, HVAC, men/material movement,
and so on.
39.5 reason for revision
First time issued for the ABC Pharmaceutical Company.