QAS-011 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 268

SOP No. QAS-011.00 Effective date: mm/dd/yyyy
Approved by:

30.1 PurPose
This SOP outlines the procedure for auditing finished products during packaging as well as other
checks carried out in the packaging area.

30.2 resPonsibility
The QAI and the packaging supervisor will be responsible for following the procedure and the QA
manager will be responsible for systems compliance.

30.3 Procedure

1. The following checks will be carried out on the packaging lines while carrying out
in-process checks in the section.
• Check that the area is clean and meets all the GMP requirements.
• Check that all packers/operators are properly dressed and have their hair properly
covered.
• Tally the commodities with master packaging instructions requisition and also conirm
that over-printed labels and cartons have been checked by the packaging supervisor
prior to packaging.
• Tally the commodities and product with packaging instructions.
• Conirm that all the relevant SOPs are being followed.
• Conirm that the irst coded label and cartons have been checked and signed off by the
packaging area supervisor.
• Check that rejected labels, cartons, other commodities, and the product are kept in
separate and properly labeled containers.

2. The following procedure is to be followed for audit checks of packed units during the pack-
aging process:
• Audit checks have to be carried out on each packaging line every hour or on the basis
of units packed or processed on an hourly basis as per the attached sample plan
(Annexure II).
• Record all the information on the QA inal packaging record (Annexure IV).
• Collect random samples as per the sampling plan from the packed unit pallet lying in
the area.
• Refer to Annexure I for defects grouping.
• If any defect is found above the acceptance level, inform the supervisor and quarantine
the lot packed between the last two consecutive checks of QAI.
• Ask for 100% inspection of that portion for sorting out the defectives.
• Keep the rejected lot segregated with label “To be sorted” until corrective action
is taken.
• After 100% inspection of the quarantined lot/portion, collect the samples and decide
the disposition as per the acceptance plan.
• Enter the defects and action taken on the QA inal packaging record of the
relevant batch.