Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:
i. Collect randomly a sample of ~100 tablets from the separated portion.
ii. Take 20 tablets (out of those hundred tablets) and weigh—calculate the average weight
which should be within ±3% of the theoretical weight.
iii. Weigh individually 20 tablets and note down their weights.
Action limits
For Group 1:
Not more than 2 tablets differ from the average weight by more than ±5%. None differs from the
average weight by more than ±10%. If the above action limits are not met, then reject and discard
that portion of the compressed tablets.
For Group 2:
Not more than 2 tablets differ from the average weight by more than ±7.5%. None differs from the
average weight by more than ±15%. If the above action limits are not met, reject and discard that
portion of the compressed tablets.
For Group 3:
Not more than 2 tablets differ from the average weight by more than ±10%. None differs from the
average weight by more than ±20%. If the above action limits are not met, reject and discard that
portion of compressed tablets.
Record any deviation observed in the remarks column of the control chart.
29.3.5.2 hardness checks
During tablet compression process, check the hardness of three tablets on the hardness tester or
tablet testing system and note down the reading on the control chart.
Action limits
1. None of the three tablets should differ from specification range.
2. If a single tablet differs from the specification range, get the machine adjusted and check
the compressed portion by the laboratory procedure.
Laboratory procedure and action limit
1. Collect random samples from the last compressed and separated portion.
2. Record the hardness of 10 tablets.
3. Calculate the average of 10 tablets.
4. Average of 10 tablets should not differ from the specification range.
5. If average hardness of 10 tablets differs from the finished specifications, reject and discard
that portion or get the disposition from QA director.
29.3.5.3 thickness checks
During tablet compression process, check the thickness of three tablets and note down the reading
on a control chart. Note down any deviation observed in the remarks column of the control chart.
Action Limit
None of the three tablets should differ from specifications. If any tablet differs from the specification
limits, get the machine adjusted and check the compressed portion by the laboratory procedure.
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