Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:
a. Adjust if:
i.
X crosses ±3% from the theoretical weight.
OR
ii.
2 tablets cross ±5% from the theoretical weight.
OR
iii.
1 tablet crosses ±10% from the theoretical weight.
iv.
Range crosses UCL of 30 mg.
For Group 3:
As per USP limits (NMT 2 tablets ±10% none ±20%) (tablet weight LT 130).
a. Adjust if:
i.
X crosses ±5% from the theoretical weight.
OR
ii.
2 tablets cross ±10% from the theoretical weight.
OR
iii.
1 tablet crosses ±15% from the theoretical weight.
iv.
The range crosses UCL of 15 mg.
b. Adjust, separate, and check as per laboratory procedure and limits for disposition decision
of the compressed tablets since the last check:
For Group 1:
i. If more than 2 tablets cross ±3% from the theoretical weight.
OR
ii. If more than 1 tablet crosses ±5% from the theoretical weight.
OR
iii. If 1 tablet crosses ±10% from the theoretical weight.
For Group 2:
i. If more than 2 tablets cross ±5% from the theoretical weight.
OR
ii. If more than 1 tablet crosses ±10% from the theoretical weight.
For Group 3:
i. If more than 2 tablets cross ±5% from the theoretical weight.
OR
ii. If more than 1 tablet crosses ±10% from the theoretical weight.
a.
Ask to adjust the machine and crush the tablets compressed since the last check.
For Groups 1, 2, and 3:
i. If the laboratory criteria are not met for individual tablets.
29.3.5
l
aBoratory
P
rocedure
and
l
imitS
29.3.5.1 Procedure
If the weight of individual tablets does not meet the action limits, then check the separated portion
compressed during that period of time in the following way:
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