Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:
29.1 PurPose
This SOP outlines the procedure for correct in-process audit checks of variables and physical attri-
butes during compression operation of tablets and its requirements.
29.2 resPonsibility
The area QAI is responsible for carrying out the checks and the QA supervisor is to ensure that the
system is followed.
29.3 Procedure
At first the shift QA inspector will check the following.
29.3.1
a
rea
and
e
QuiPment
c
learance
c
heckS
1. Temperature and humidity
2. Equipment and area clearance
3. Area and equipment release
4. Start-up check to allow the process to run
During compression operation the QA inspector will take samples every hour and confirm the
following:
1. Weight variation
2. Hardness
3. Thickness
4. Disintegration
5. Friability
6. Attribute characteristics
29.3.2
t
emPerature
and
h
umidity
c
heckS
1.1 To check that the temperature and humidity during the operation is within the specified
limits.
Tablet: RH—NMT 50% or as per the product specifications; temperature—25°C ± 2°C
1.2 To record the RH and temperature on the control chart for tablet compression. Any devia-
tion observed should be written in the remarks column of the control chart.
29.3.3
e
QuiPment
and
a
rea
c
learance
c
heckS
2.1 To check and confirm that the equipment and area clearance given by the production
supervisor is as per the written procedure.
2.2 To record any deviation observed in the remarks column of the control chart.
29.3.3.1
Procedure
2.3.1 To check the area, equipment, and machine for general cleanliness on every round.
2.3.2 To check the cleanliness of the containers in which granules are kept as well as the
containers in which compressed core tablets will be kept.
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