QAS-020 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 355

SOP No. QAS-020.00 Effective date: mm/dd/yyyy
Approved by:
• Therawmaterial/packagingmaterialinventorycard.
• TheQCtestreportandthemanufacturer'scertiicateofanalysis.
39.4.3 P roduct B atch r ecord
a. The batch record(s) for the batch(es) supporting the submission will be examined to ensure
that
• Thebatchdocumentauditchecklistisavailable.
• Theapprovedmastermanufacturingformulaisavailable.
• Allthereleasedrawmaterialsissuedbystoresandsupportingdocumentsareavailable
and correct.
• Allmanufacturingstepswereperformedaccordingtotheformula.
• Eachstep“Performedby”and“Checkedby”initialswithdateareentered.
• Allcalculationsarecorrect.
• Allweighingprintoutsareavailable.
• Allthesupportingdocuments,forexample,sterilization/lyophilization/drying/CIP
and SIP, and so on, printouts are available and correct.
• Allin-processtestswereperformedasperprocedure,andrecordsareavailable.
• Equipmentcleaninglogsforeachpieceofequipmentusedinthemanufactureofthe
batch are available.
• Alltestreports(in-process,inishedproduct,etc.)withrawdataarealsorequired.
• Approvedmasterpackaginginstructionsareavailable.
• Allthereleasedpackagingmaterialsissuedbystoresandsupportingdocumentsare
available and correct.
• Reconciliationrecordforlabels/cartons/product.
• Allcalculationsarecorrect.
• Allcalculatedyieldsarewithinestablishedlimitsand,ifnotso,areadequatelyinves-
tigated and explained on the batch record.
b. The manufacturing procedure used for manufacturing the test batch is the same as the
master formula to be included in the submission.
c. An accountability test for the batch will be performed, including the bulk and packaged
product, for comparison with the actual yield entered on the batch record.
39.4.4 Qc r ecord
The QC test report, certificate of analysis and test specifications will be checked for each compo-
nent to ensure that
a. The raw material (active and in-active) was released by QC before usage in the batch.
b. If the date of initial QC testing exceeds the date of usage by >1 year, it must be verified that
the appropriate raw material (RM) retesting has been performed.
c. It must be verified that each required test on the test specification has been performed.
d. The manufacturer's lot number should be checked on each of the following documents to
ensure consistency:
• The RM receiving log entry
• The QC report
• The certiicate of analysis