09-22-2017 09:34 AM
09-22-2017 10:18 AM
Can you send me the regulation that states this requirement? I have no idea what is driving this unreasonable expectation.
09-22-2017 10:36 AM
09-22-2017 03:03 PM
I reached out to my temperature and humidity gurus on an asinine requirement and asked for their thoughts. Here is an excerpt of one of the responses. They are pharma scientists and one of them wrote the attached article that was published in PF. It is a very technical document but the conclusion is where it all comes together.
The issue of relative humidity control is challenging because most people, and here I include scientists, do not stop to think what relative humidity actually is: the ratio of the amount of moisture in the air to the amount that the air could hold at a given temperature. It is this link between relative humidity and temperature that is often lost. The amount of moisture in the air is negligible at refrigerator temperatures, but the RH is high because the air can hold very little moisture at those temps. I have attached a copy of the USP Stimuli article I wrote with some colleagues on this topic. Here is the key conclusion:
Because of the moisture protection afforded by proper packaging, humidity excursions of 7 days or less are unlikely to result in loss of product quality.
It is hard to imagine that controlling humidity in pharmacies is value-added. Pharmacies where there is no temperature control where the resulting high temperatures could involve relative humidities that are significant, but I would still worry more about the risk to product quality from the high temperatures than the humidity.
Hope this helps.
09-22-2017 05:38 PM
09-26-2017 10:18 AM
Our VPP inspection included non-compliance in VPP # 42.00 - 42.03 Humidity in nonsterile compounding and VPP 49.00 Sterile compounding - "Humidity-in the compounding area is maintained to provide humidity in the ranges warranted by specific drug product storage requirements. If drug produts require storage in a "dry place", humidity is not to exceed 40%. Generall recommended range is 35-60%. I am looking for how to respond to VPP.
09-26-2017 11:55 AM
Verified Pharmacy Program - through the National Association of Boards of Pharmacy. The NABP VPP inspection was in lieu of the State Board of Pharmacy (MI) inspection, as MI does not have enough trained compounding inspectors.
09-26-2017 12:52 PM
That is kind of how I read the WI requirement as well. If a drug storage requirement is a dry place, then it must be stored as such. If the manufacturer does not require it, then 30%-60% is fine.
09-26-2017 01:54 PM
Where do I find the humidity requirements in USP? I only find general requirements in USP 795, not in USP 797. I did find USP 659 Packaging and Storage Requirements (official May 1, 2019), however no mention is made regarding humidity standards.