Hi
I implemented Electronic Batch Recording system for API
Also going for Computer systems validation as per GAMP
The problem here is, Client is asking to submit “COMMISSIONING TEST PROTOCOL (CTP)”, which i not even heard.
Can any one please suggest me:
what actually a CTP is?
At what stage of validation it required?
what is the difference between IQ and CTP?
What does a CTP should contain
It is used to provide accurate & complete data and documentation to support system qualification and operational support. Commissioning documentation & deliverables are to be robust and suitable for supporting Qualification.
Commissioning - “A well planned, documented and managed engineering approach to the start-up and turnover of facilities, systems and equipment to the End-User that results in a safe and functional environment that meets established design requirements and stakeholder expectations.” *
*(ISPE Baseline Pharmaceutical Engineering Guide, vol. 5, March 2001)
Commissioning program activities are conducted and robustly documented.
Qualification activities verify that the commissioning task was conducted and reference the commissioning documents & related deliverables. This approach provides moderate benefits to efficiency without significant decrease in effectiveness