A USP Inspection is no different than a JCAHO Inspection. These inspectors are looking for well thought out reasons for why you’re doing what you’re doing. A mindless drawing on a piece of paper has no value!
A more comprehensive and risk-based sampling plan is foundational for USP Compliance. If developed, owned, and maintained by the pharmacy, it represents a compliance cornerstone.
Ultimately, we are trying to justify what we do as a pharmacy to the inspector. We should not depend on dozens of pages and cryptic drawings to make the first impression.
Examples of a sample plan (this one was for particle counts for one hood; it accomplishes one thing; letting you know where the particle was taken).
The superpower I am talking about is the elimination of questions prior to them being asked by the inspector.
Inspector questions could include:
· Is your viable sampling collected based on a Risk Assessment?
· How many nonviable particle counts are taken and where?
· What are the performance criteria of your room?
· What direction is air supposed to flow between the SEC?
· Are the room dimensions consistent across all calculations?
· What kind of compounding is done in this room?
There is not one correct way to create a floor plan but the above plan provides a visual snapshot for the inspector. It is comprehensive and encompasses many of the requirements of USP while illustrating understanding of these requirements to the inspector. Key sections include:
· Facility Identification
· SEC Identification
· Measurements
· USP Required Room Specifications
· Risk Assessment
Because of the frequency of some viable sampling is important for sampling locations to be consistent for trending. This is another reason for facilities to enforce sampling locations.
In closing, facilities should think about maintaining their own floor and sample plans.
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