We are working on an annual review of our cGMPs and are looking to clarify a statement that was made in the current revision. The statement is
We do not enforce the first part of the statement and it was originally written because we had products that were prone to absorb odors (There was a story of one product that when the bag was open it smelled of perfume from a person involved in production).
We still have some products that will absorb odors but we don't strongly enforce this rule anymore because there is not as much issue. The problem is coming up with a statement that says "you odor is to strong" (good or bad) without offending.
We came up with this revision so far:
I think the statement is better but I also think that "emit any strong odors" could be taken as odors of the gaseuos type which is not the major concern.
Does the statement make it clear enough that strong "pleasant" (perfumes, colognes) or "unpleasant" (uncleanliness) odors are both an issue?
I am looking for any thoughts or if anyone has a written statement or policy that they currently use that could help.
Thanks!
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