Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:
2.3.3 To check proper labeling on the bulk containers in which granules and core tablets are
kept.
2.3.4 To check whether the operator is wearing a mask, a pair of gloves, a cap and that the
hair is covered properly.
2.3.5 To tally the product name and batch number on the area/equipment/machine clearance
with the master manufacturing formula requisition.
2.3.6 To check that the compression room door is properly closed to avoid cross
contamination.
29.3.3.2 area release
• Perform weight variation on 10 tablets.
• Check physical attributes of tablets.
• Perform disintegration test, hardness, and thickness.
• Also conirm that the correct punches of products are being used by measuring the diam-
eter, and ensuring proper engraving on both sides of the tablet.
If all the above-mentioned tests meet the product specification, then allow the process to run by
issuing an area release label and send the samples to the QC for chemical analysis, assay, and
dissolution.
29.3.4
c heckS during c omPreSSion P roceSS
29.3.4.1
Weight variation checks
1.1 Initially the machine will be set up by the supervisor as per the written procedure.
1.2 Action limit
i. Once the machine has been set up and the process is allowed to run, collect the
samples from the machine.
ii. Randomly collect 10 tablets and check their average and individual weights on a bal-
ance for checking the correct weight.
iii. Record the results on control charts.
iv. Decide the disposition as mentioned below.
Note: When the tablet testing system is used, attach the printed report with the X and R charts and
enter the average weight and range on this chart and plot graphically mentioning the container
number.
For Group 1:
As per the USP limits (NMT 2 tablets ±5% none varies by 10%) tablet weight 325
and above
a. Adjust if:
i.
X crosses ±2% from the theoretical weight.
OR
ii.
2 tablets cross ±3% from the theoretical weight.
OR
iii.
1 tablet crosses ±5% from the theoretical weight.
iv.
Range crosses UCL of 50 mg.
For Group 2:
As per the USP limits (NMT 2 tablets ±7.5% none ±15%) (tablet weight 130-325 mg/
tablet).
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