Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:
(continued)
sampling Points
description
room no.
activity
type
frequency
a
Hot
Cold
Tablet compression-V
Once weekly
Hot
Cold
Sugar coating
Once weekly
Hot
Cold
Technical room-I
Once weekly
Film coating-I
Hot
Once weekly
Film coating-II
Hot
Once weekly
Film coating-III
Hot
Once weekly
Hot
Hot
Cold
Cold
Washing area
Once weekly
a
It is appropriate to increase or decrease sampling based on the trend performance. The time and date can be
determined according to the activity.
Note:
The sampling points are not tested due to unavailability of access. However, all finished products are
tested.
8.3.5.9
sampling Points of a nonsterile Plant (liquid dosage)
sampling Points
description
room no.
activity
type
frequency
a
Hot
Hot
Cold
Cold
Raw material storage tanks
Solution preparation room
Hot
Cold
Twice a week
Hot
Cold
Washing area
Semisolid manufacturing
room
Hot
Hot
a
It is appropriate to increase or decrease sampling based on the trend performance. The time and date can be
determined according to the activity.
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