QAS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 249

SOP No. QAS-008.00 Effective date: mm/dd/yyyy
Approved by:
B.1 Physical attributes of containers, closures, and product
B.1.1 Confirm that the bottles and caps which are used in the area are clean and no foreign
particles are present in them.
B.1.2 Collect samples randomly from filled units as per the sampling and acceptance plan
and check the physical characteristics of containers, closures, and product for any
defects as follows:
i. Foreign particles in the granules
ii. Chipped brim
iii. Broken cap and cracked containers
iv. P.P. caps broken bridges, cut marks on P.P. caps
B.1.3 Confirm that the checks taken by the line supervisor in that period is as per the writ-
ten procedure.
B.1.4 Enter the readings and deviations on the control chart for granules filling.
B.1.5 If audit checks cross the cumulative acceptance number, then inform the supervisor
and ask to segregate the portion.
B.1.6 Collect samples again from the segregated portion and decide the disposition of the
segregated lot. If it passes, then release the portion. In case of failure, quarantine the
segregated lot and ask for 100% inspection.
Note: The segregated portion could be completely finished units or partially finished or both.
B.2 Fill weight checks
Confirm that the machine has been set within pre-set limits before operation by the line boss.
B.2.1 Once the machine has been set and the process has been allowed to run, collect the
samples on an hourly basis.
B.2.2 Take one filled bottle from each nozzle of the running machine. If the machine has
only one nozzle, at least three bottles should be taken for weight variation.
B.2.3 Completely empty them on the pan of the balance one by one making sure that no
powder is left in the bottle.
B.2.4 Note the net weight of each individual bottle.
B.2.5 Record the results on the control chart for granules filling.
B.3 Removal torque checks
B.3.1 Collect samples randomly from filled and sealed bottles as per the sampling plan.
B.3.2 Confirm the removal torque on a torque tester.
B.3.3 Note the torque readings on the control chart for granules filling.
B.3.4 If audit checks cross the cumulative acceptance number, then inform the packaging
supervisor and ask to segregate the portion.
B.3.5 Collect samples again and decide the disposition of the segregated lot. If it passes,
then release the portion. In case of failure, quarantine the segregated lot and ask for
100% inspection.
Note: The segregated portion could be completely finished units or partially finished or both.