Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
4. Quality assurance is responsible for
4.1
Process inspection/monitoring
4.2
Air monitoring for nonviable counts
4.3
In-process sampling (if required)
4.4
Batch documents review
6. The validation group is responsible for the following:
6.1
MFM initiation and review with the concerned departments
6.2
Protocols initiation and review with the concerned departments
6.3
Monitoring of completeness, accuracy, technical excellence, and applicability
6.4
Scheduling of the validation runs (in conjugation with the manufacturing
department)
6.5
Conducting of the validation runs including recording of all data, and so on
6.6
Data review and validation run acceptance
6.7
Final report preparation
6.8
Scheduled revalidation
7. Assistant manager QA, microbiological section head, QC director, sterile area production
manager, operations manager, manufacturing director, and QA director will evaluate and
approve the results in case of failure and determine the remedial actions.
51.3
freQuency
51.3.1
i nitial P erformance Q ualification
1. 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 fill-
ing area (Class 100) (such as addition/removal of HEPA housings)
51.3.2 P eriodic P erformance r eQualification
At least every 6 months for each product/container configuration and aseptic filling line.
1. Prior to scheduled 6 months intervals in case of
• Facility modiication
• Equipment modiication
• Change in equipment/personnel
• Anomalies in end product sterility testing
• Anomalies in environmental testing results
51.3.3 r ePeat P erformance r eQualification
As aseptic process or filling line shall be subject to repeat of performance qualification studies when
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