QAS-020 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 356

SOP No. QAS-020.00 Effective date: mm/dd/yyyy
Approved by:
e. Check analyst register, logs, register.
f. All test reports (in-process, finished product, raw material, etc.) will be examined to ensure
that
• All raw data including calculations, curves, chromatograms, and so on. Adequate raw
data exist to support all test results.
• The physical description entered in the reports is consistent with the actual description
of the product.
• All the required testing was performed, and is within established speciications.
g. Environmental monitoring records.
39.4.5 S taBility B atch r ecord
Stability test results will be examined to ensure that
a. Stability testing protocol is available.
b. All other documents as described in Section 39.4.4.
c. Adequate raw data exist to support all test results.
d. The physical description entered in the reports is consistent with the actual description of
the product.
e. All the required testing was performed, and is within established specifications.
f. All stability reports, with raw data (calculations, curves, chromatograms, etc.).
g. Stability test specifications are also required.
h. The stability samples will be examined, and the following information recorded:
• Physical description of the product (color, shape, scoring, markings, etc.).
• Packaging system for sizes on stability (bottle manufacturer, bottle size, closure type,
presence of desiccants, etc.).
i. Concluded stability test report.
39.4.6 v alidation r ecord
The following validation records should be reviewed:
a. Test method validation reports
b. In case of injectable
• Bioburden method validation on raw material and inished product
• Endotoxin method validation on raw material and inished product
• Sterility method validation using the actual product
c. IQ/OQ and PQ validation record
d. Facility qualification
e. Heating ventilation air conditioner (HVAC) qualification
f. Utilities/water qualification
g. Process validation record
h. Cleaning validation record
i. In case of injectable
• Heat distribution and heat penetration records for mobile vessel
• Heat distribution and heat penetration records for autoclave (each load)
• Heat distribution and heat penetration records for hot sterilization tunnel (each size of
ampoule/vial)
• Heat distribution record during SIP cycle for freeze dryer