How can you get such good grades, and still have absolutely no common sense?” It was true, I was lacking in that essential skill for survival in this world of ours. So, where do we get common sense?
Years later, at the GMP Institute, I got my answer.
Common sense is the accumulated wisdom we gain from learning from mistakes.” Lucky for us, we need not make all the mistakes ourselves. We can, instead, learn from the mistakes of others. That is exactly what the GMPs try to help us do.
Another way of describing common sense is by the three levels of competency:
- Conscious incompetence: This person knows little and knows he is incompetent. This is the novice.
- Conscious competent: This person is gaining skill, but still uncertain of his ability.
- Unconscious competent: This is the expert, who often thinks of their ability as just plain old common sense.
If you are new to GMPs, that might about as helpful as my father’s admonitions were, back in my childhood. The simple truth is that you may not have enough experience to have any common sense. So how do you gain common sense without risking costly mistakes, or worse yet, risking the health and safety of customers? Here are some ideas:
- Read technical journals such as “GMP Trends” and the “Gold Sheet.”
- Review the Preamble to the GMPs. The answers the Commissioner gave to each comment received provides the reasoning behind the guideline.
- Review you company’s Form 483 citations and responses. Consider the underlying logic behind each citation and how the company responded to fill the gap.
- Remember that the GMPs are designed to assure consistently safe, pure, and effective products. Consider how your compliance plan contributes to this overall goal.
- Attend seminars and conferences where you can learn and ask questions about the current GMP concerns. ASQ-FD&C group offers these every year. They are local and reasonably priced.
With perseverance, you will be an Unconscious Competent. Before you know it, it’ll be you who says: “It’s just common sense.”
Adela Crandell, holds ASQ-CMQ/OE certification, as well as RAPS-RAC. Before retiring from Abbott, she spent over 30 years in quality and regulatory affairs at G.D. Searle, NutraSweet, and Solvay Pharmaceuticals. Now she toils at gardening, bicycling, and writing her first novel.