What to perform in HVAC Validation?
Than Answer is your User Requirement Specification, which includes requirement.
For the requirement you can refer WHO guideline : http://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC_Part2_QAS18-759-15022018.pdf?ua=1
above is under draft, but still you can find the requirement.
Test Methodology, Report and criteria , you can refer ISO 14644
Ideally Protocol should cover below requirement (But not limited to) :
- Objective
- Scope
- Responsibility
- Training Participation
- Instrument detail to be used for the Validation activity and their status
- SOP detail
- Acceptance criteria of the test
- Methodology/Procedure of the Test
- Reporting Result
- Non Compliance observed (if any)
- Summary and Conclusion
- Approval of the protocol
Some industries follow Pre Approval and Post Approval concept. but it may vary