Quick question: are your standard operating procedures compliant with GMPs?
Interpretation – that elusive mode of perception – drives the degree of compliance with 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 in the regulated industry know this, and it’s fair to say that 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 standard operating procedures products on the market today that merely restate regulations. The set of policies and procedures should include much more to interpret guidelines accurately. 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 wise long-term investments. 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 SOPs 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.