Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-014.00 Effective date: mm/dd/yyyy
Approved by:
In the case of container pack, the QAI will
1. Check the calculation of the tablet/capsule weight for pack size or count the tablets/
capsules (as the case may be).
2. Check five filled containers for net weight of tablet/capsule or count the tablets/
capsules.
3. Check the correct and proper labeling (if the packaging operation is running side
by side with the filling) and if found within specifications will allow the process to
run by giving release.
B. Audit checks will be carried out during filling operations
B1. Physical attributes of containers, closures, and the product
a.
Confirm that the containers and closures which are used in the packaging are clean and
no foreign matter is present inside them.
b.
Collect 32 containers randomly from the filled units to check for the defective samples.
Check the following defects:
1. Foreign matter in the containers and closures
2. Silica gel missing
3. Chipped or cracked containers or broken plastic cap and improper seal
c.
Enter the readings and deviation on in-process control chart for filling of tablets/
capsules.
d.
If any defect is found, then inform the packaging supervisor and ask to segregate the
portion for sorting and corrective action.
Note:
The segregated portion could be completely finished units, partially finished, or both.
B2. Less count check for container pack by weight
1. Take three sets of 100 tablets/capsules, and weigh and calculate the average weight of the
pack size of tablets/capsules on the basis of the average weight of a single tablet/capsule.
2. Randomly pick up five containers and determine the net weight of the tablet/capsule of
each container.
3. Weights should be within ±1% of the target weight calculated.
4. If the weight is not found as per the limits mentioned above, then ask the supervisor to
quarantine the portion already filled.
5. Collect samples from quarantine, and decide the disposition of the segregated lots. If they
pass, then release the portion.
6. In case of failure, ask to adjust the quantity of tablets/capsules in each quarantined unit.
Note:
The segregated portion could be completely finished units, partially finished, or both.
33.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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