Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-014.00 Effective date: mm/dd/yyyy
Approved by:
33.1 PurPose
This SOP provides the stepwise procedure for auditing and confirming the tablet/capsule fill checks
and physical attributes of containers, closures, and the product and also to check other requirements
of the area.
33.2 resPonsibility
The QA inspector and QA officer will be responsible for following the procedure. The QA manager
will be responsible for system compliance.
33.3 Procedure
In-process audit checks will be carried out at the start up and then every hour of the filling process.
This procedure is divided into two parts:
A. Following audit checks will be carried out to ensure system and process
A1. Equipment and line clearance checks
a.
The QAI will check the presence of equipment and line clearance issued by the pack-
aging supervisor.
b.
Confirm that the area and equipment are clean.
c.
Confirm the cleanliness and proper labeling on bulk containers in which tablets/capsules
are kept.
d.
Confirm “release” label present on the bulk containers.
e.
Check whether operators are wearing masks, gloves, and factory shoes (clogs), and
hairs are properly covered.
f.
Tally the product name and batch number on line clearance with master packaging
instructions (MPI) requisitions and labels on the bulk container and make sure all entries
are correct.
g.
If all requirements are met, then allow the process of filling of tablet/capsule to run.
A2. Humidity and temperature checks
a.
Check the relative humidity (RH)/temperature of the filling area.
b.
RH for the tablet product: NMT 50% or as per product specifications
RH for the capsule product: NMT 50% or as per product specifications
Temperature of the area: 25°C ± 2°C
c.
Record the temperature and RH on the control chart (for filling/blistering of capsules
and tablet products).
A3. Start up checks for the process to run
When the machine has been set, the packaging supervisor will inform the QAI who will
give the release to allow the process to run.
The area QAI (packaging) will collect 10 strips coming out of the machine and will
check the strips for correct engraving of batch number and manufacturing and expiry
dates. The QAI will then perform the leak test as per SOP: QAS-000. If the leak test results
are found within specifications, he/she will issue green label for packaging line release and
allow the process to run.
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