QAS-017 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 323

SOP No. QAS-017.00 Effective date: mm/dd/yyyy
Approved by:

2. Physical attributes of the container and closure

3. Clarity of the liquid

4. Torque

5. Labeling and printing on labels and cartons

6. Leak test (at least once/shift)

If all parameters are within specifications, then the QAI will give the line release and issue a release
label to allow the process to run.
During filling operation, checks will be carried out for the physical attributes of filled packs
(bottles and caps).

Procedure

1. Check the cleanliness of the primary containers and closure before use.

2. Collect the sample from filled units as per the acceptance plan attached and check defec-
tive characteristics of bottles such as broken, chipped brim, cracked, and so on and for caps
broken bridges and cut marks on PP caps.

3. Check 13 units hourly for liquid spills, PP caps broken bridges and cut marks on PP caps
as per the acceptance sampling plan.

4. Check the clarity of the liquid in five bottles.

5. Enter the findings in the relevant liquid filling control chart.

6. If any deviation is observed, write in the remarks column of the control chart the corrective
action taken.

Action limit

1. If in-process control checks cross the cumulative acceptance number in the first check,
then ask the operator to adjust the machine and check again.

2. If two successive in-process control fill checks cross the cumulative acceptance number,
the units packed since the last check by the line supervisor must be quarantined, resam-
pled, and inspected again and if it still crosses the acceptance number, then quarantine the
lot for 100% inspection and inform immediately the packaging supervisor to take correc-
tive action.

Volume checks

Confirm that the machine is running within limits as per the MPIs and in-process product
specifications.

Procedure for taking the volume check

1. Collect a specific number of filled bottles corresponding to the number of nozzles of each
machine.

2. Determine the volume dispensed in each container by emptying each in a calibrated, dry
volumetric cylinder.

3. Record the results on the control chart for liquid filling and decide the disposition as
follows:

a. Adjust if:

i. X crosses in-process limits.