QAS-009 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 254

SOP No. QAS-009.00 Effective date: mm/dd/yyyy
Approved by:
28.1 PurPose
This SOP outlines the procedure for correct strips/blisters, sealing checks, attribute characteristics
of product, foil, and area requirements.
28.2 resPonsibility
The area QAI and officer will be responsible for implementing the procedure and the QA manager
will be responsible for SOP compliance.
28.3 Procedure
A. Audit Checks to be Performed for Line Clearance
At the start the QAI will check the following.
Note: Check all the aluminum foil rolls to ascertain that printing of the matter is on the correct
side (shiny side).
1. There should be no other product in the area near the sealing machine.
2. Check that the area/equipment clearance near the machine and all the entries are correct.
3. Tally the product name and batch No. on area/equipment clearance with the label on the
bulk container and BPR 1 (batch packaging record).
4. Check that the pack size is as per the master packaging instructions (MPI) requisition.
5. Check whether the operator is wearing a mask, a cap, gloves, and clogs.
6. Confirm that the RH value and temperature recorded by the supervisor is as per the prod-
uct requirements mentioned in the MPI. If not, inform the area supervisor for corrective
action.
7. When all the above requirements are met, countersign the line clearance sheet.
Line Release
After getting the line clearance, the packaging supervisor will start the operation and, after setting
the machine and product as per specification, will ask the QAI to check to give the line release.
a. The QAI will confirm that the batch No., expiry date, and the manufacturing date are cor-
rect and properly engraved.
b. Check the following randomly:
1. Pinholes
2. Empty pockets
3. Open strips/blisters
c. Perform the leaker test on strips/blisters
d. Check the sealing through the aluminum peel-off test
If all requirements are found to meet the specifications, then the QAI will give the line release by
issuing the green release label.
B. Checking for Attribute Characteristics of Sealed Strips/Blisters
1. Audit checks of the strips/blisters during sealing for its attribute characteristics will be
performed on an hourly basis.