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Generation and execution of Critical Test Protocols (CTP):

Global Engineering and Maintenance:


Commissioning an d qualification designee reviews and approves
1.
2.
3.
4.

Critical Test Protocol for Execution


Executed CTP
Assigns commissioning resources to the project
Generates CTPs and data packs

QPAV:
1.
2.
3.
4.

Critical Test Protocol for Execution


Executed CTP
Associated data pack and deviations
Ensuring Compliance with and traceability to the FCCA (Functional
Components and Criticality Assessment)

Procedure:
Verification:
Depending on the location of the equipment, there will CTP and NCTP for the same
equipment.
Within the respective system boundary,
1.
2.
3.
4.
5.

All GXP critical functions,


GXP critical alarms/ interlocks
GXP critical instruments
Contact critical components and
Safety Critical Components

Come under the critical Test protocol.


1.
2.
3.
4.
5.

All Non-critical functions


Non-critical alarms/Interlocks
Non-critical Instruments
HSE critical alarms/Interlocks
HSE critical Instruments

Come under the Non critical test protocol


If a NCTP is not justified, the above mentioned things can be placed in a CTP.
A CTP includes the completion of 3 stages.
1. Mechanical completion
2. Functional verification
3. Post functional verification.
Mechanical completion includes
1. Drawing verification

2. Sanitary piping verification


3. Materials of Construction verification
4. Electrical verification
5. HVAC verification
6. Non- sanitary piping verification
7. Equipment verification
8. Safety/Bio-safety verification
9. Documentation verification
10.Pending issues from FAT

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