Biomedical Engineering Reference
In-Depth Information
aBc Pharmaceutical comPany
SOP No.: QAS-032
Issued on:
Revision No.:
Initiator name:
Attachment No. I
Media Fill Request Form
From
: Manufacturing director/operations manager
To
: List
Vials/Ampoules
Date
:
Size:
Subject :
Initial/Periodic Performance Qualification
The media fill is scheduled from
to
to comply with the SOP, QAS-032 for
the following reason.
Tick Applicable Box
1.
Initial Performance Qualification
Three media fill runs are required for the following (this list is not all inclusive)
1.1 New filling room or machine
1.2 Major room modification (such as wall or ceiling reconfigurations)
1.3 New equipment or new machine which has product contact or affects
product flow which is not an exact equivalent of the original equipment
1.4 Major mechanical or line configuration changes (such as new
equipment additions or major preventative maintenance)
1.5 Major HVAC changes which may impact air flow patterns related
to the critical filling area (Class 100) (such as addition/removal of
HEPA housings)
1.6 A media fill failure with a conclusive nonpersonnel assignable
cause (determined during the investigation process)
1.7 New product/process evaluation (number of runs to be
determined on a case by basis)
2.
Periodic Performance Qualification
One media fill run is required for the following (this list is not all inclusive)
2.1 Routine requalification (every 6 months)
2.2 Major modification to areas adjoining filling rooms
(such as expanded core area)
2.3 Equipment modification
2.4 Change equipment/personnel
2.5 Anomalies in end product sterility testing/environment
2.6 Any other reason:
3.
Repeat Performance Qualification
As aseptic process or filling line shall be subject to repeat of performance
qualification studies when:
3.1 An action level exceeded, unless an assignable cause for the
exceeded action level is identified
3.2 Production lines have not been in operation for an extended
period of time, e.g., more than 6 months
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