1. Ensure that the protocol has been written from an approved design document. There’s
(Design Specification) if the design is going to change. Your protocol needs to reflect
2. The person who is developing the protocol needs to understand what needs to be
tested.
3. Ensure that you have sufficient time before you run the protocol to dry run it.
4. Treat the dry run as a real run, document all of your test results like you would the real
5. If you have time, get an independent person to review your protocol, they will spot
6. Start the execution at the start of your day when you are fresh, not at the end when you
7. Ensure that all of the prerequisites have been performed before execution
8. Have deviation and discrepancy forms at hand to write them up as you go along (You
Before you do validation on a process, you have to be sure that the equipment has passed
qualification
Globaly....yes, you can say like that, but...perhaps is better to say..calibration is one of
condition to make qualification, as well as qualification is one of condition to make
validation.
Also, don't forget..this is important and very clarify (from the first post)..
Before you do validation on a process, you have to be sure that the equipment has passed
qualification.''