Quick question: are your standard operating procedures compliant with GMPs?
Interpretation—that elusive mode of perception —is what really drives the degree of actual compliance to regulatory
guidelines. Given the general nature of many of these guidelines, the field
for interpretation is wide open, increasing the chance of
misunderstanding. Enough service providers to the regulated industry
know this, and, it’s fair to say, some capitalize on it. Unfortunately,
there is no way to evaluate the quality of their product except by—you
guessed it—interpretation.
The best path is honest subject matter
expertise. Trust is possible, but it comes with a price of diligence to
close the gap. There are SOP products on the market today that merely
restate regulations. The set of policies and procedures should include
much more to be an accurate interpretation of guidelines. There must be
granularity around “who” and “how” to be properly grounded, go-to- work
documented rules.
SOPs built with the right structure and ingredients are a wise long
term investment. They must certainly closely mirror the actual
guidelines. They must be designed for easy understanding and maintenance
to satisfy the “c” in cGMP, and the growth of an enterprise. They must
be easy to access and reference in the actual day-to–day running of a
regulated product environment.
Regulatory status can drive business status. Scrutiny will come—can your SOP’s stand up?
InstantGMP sells a complete set of SOPs for manufacturing dietary supplements and e-liquids.
This post was written by Robert Pochadt, InstantGMP’s Sales Director