Hello all,
What is the common practice regarding Laorastories HVAC qualification in the pharmaceutical industry ?
what are the regulatories demands ?
Please advise
Moshe.
The regulatory demands depend on where you are. 21 CFR Part 58 springs to mind if you are in the USA. Don’t forget that 21 CFR Part 11 may also apply.
HVAC qualification is required when HVAC paramters have an impact on the quality of data laboratory operations etc.
As far as qualification itself, there is the ISPE Baseline Guide for Laboratories and the forthcoming ISPE Good Practice Guide for HVAC as well as other documents such as GAMP5 or even GAMP4.
The traditional approach to prove that an HVAC system is fit for its intended purpose is the IQ, OQ and PQ qualification cycle. You can follow the V-Model for a Category 5 (software) and Category 2 (hardware) system in GAMP4 (GAMP5 uses terms like verification instead of validation and drops IQ, OQ, PQ - but the industry at large is certainly more familiar with IQ, OQ and PQ). Read more in the ISPE Baseline Guide for Commissioning and Qualification. Bear in mind that whereas GAMP5 has all the new terminology the baseline guides do not.
If you want a more modern approach to qualification (basically GAMP5) then you need to sprinkle in the Risk Assessment Process. You need to identify aspects of your HVAC system that have a direct impact on GMP or GLP versus indirect impact versus no impact. The qualification method for each is different.
To do the Risk Assessment you need to set up Boston Grids per GAMP5 and go from there. You would perform an initial risk analysis where you decide really if there is any risk at all and then perform a considerably more detailed risk analysis against any functional specification and against any design or configuration specification.
Have fun. If I was to bet, I would expect to see more “traditional” approaches to C&Q right now versus a GAMP5 approach.
–
Ranjan Acharya
New Zealand