QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 109

SOP No. QCS-019.00 Effective date: mm/dd/yyyy
Approved by:
• Bottle torque (if applicable)
• Sachet illing and packing
• Sachet seal test
For audit checklist, refer to Attachment IV.
19.4.5 i n -P roceSS c ontrol (f iniShed P roductS )
The finished product packaging area QAIs are responsible to audit the following documents at the
end of packaging operations. The person at the quality function unit will be an authorized one from
the QA department.
19.4.6 P ackaging a rea d ocumentS
Batch packaging record
• Hand packing
• Filling and packing
• Line clearance format
• First signed coded commodities
• Reconciliation form (labels/cartons)
• Packaging report and the release of inished product (for different consignees)
• Packaging material requisition
• Time sheet
19.4.6.1 Qa in-Process
• Sampling report (manufacturing side)
• QA in-process record
• QA illing chart (cream, ointment, powder illing, suspensions, syrups, drops, blister or
strips (tablet/capsule), sachets)
• QA inal packaging records (for different consignees)
• Inspection start-up checklist with release label
19.4.6.2 any other documents
• Process change request
• Memo (sorting or any other)
• Repacking request/requisition
For audit checklist, refer to Attachment V.
19.4.6.3 finished Product Quality control
• The QC oficer will be responsible for checking the availability of completed Attachments
I through V. In addition to this, the QC officer will also check that
• Test results as reported by the QC analyst are within the speciication limits and that
there is no nonconformance in any of the tests
• The information related to the batch identity is available and correct
• For all manufacturing processes
− Analytical report (bulk product)
− Microbiological reports (when applicable)