Saturday, July 17, 2010

An Intriguing Executive GMP Tutorial

I was invited by a disheartened head of a pharmaceutical QA department to provide a private tutoring session for the company COO on the topic of Current Good Manufacturing Practices. She said that he had refused to participate in the half-day annual GMP training course.

This was a rather intriguing request.

I asked a few questions of her to be sure that I understood the need to be addressed, the objective of the private session, and any other parameters to be considered.

Her answers were just as intriguing.

The perceived need: The boss “just doesn’t get it.”
The objective: To gain his support for GMP-related decisions.
There was only one working parameter: I had thirty minutes.

I still took the assignment, well—because it was intriguing.

I sat down and wrote out a simple discussion outline of the underlying principles of GMPs and made sure that it was straight-talk and free of buzzwords. Instead of “presenting” to him, we said that the thirty minutes would just be a “conversation.”

After belabored calendar coordination, this is the outline of the conversation that took place:

1.    Patients take the individual dose, not the average—sometimes everyday for their entire life.
a.     Your patients deserve the assurance that their drug will meet every quality requirement for each dose, not just on the average.
b.    That’s the objective of GMPs, and that should be no less the objective of your business.
2.    Your manufacturing process is fraught with opportunities for unwanted variation to creep in.
a.     All the way from incoming raw materials and components, to your equipment, test methods, operators, facilities, utilities, and so forth.
b.    Continually producing a product that is faithful to what your market approval was based on and all your quality requirements only happens when you do so intentionally.
3.    Your standard operating procedures declare how you intend to control variation.
a.     The operative word is “standardize,” not “randomize” the way you work.
b.    You have the liberty to standardize how you control variation and meet regulatory requirements to be as efficient as possible.
4.    When you follow your standard operating procedures, records are created that capture the results of your intent.
a.     The way you record results and when you enter these results are important.
b.    Sometimes recording of the result is so critical to the outcome that it must be witnessed.
5.    These records contain data that measure how well you achieved your intent.
a.     The data can be interpreted into information.
b.    The information can be transformed into targeted action for improvements.
6.    A regularly review of these measures by a cross-functional management group is your mechanism to provide oversight and governance.
a.     The review enables you to be an anticipating organization, rather than a reactive one.
b.    This review is your primary source of knowledge that you are operating in a state of control.
7.    When you put this all together, you will be able to maintain economical control of quality and increase your ability to compete.
a.     GMPs are an enabler of your business, not an antagonist.
b.    GMPs enable continuous quality, which is quality you trust.
8.    This pretty much summarizes the purpose of GMPs, which are embodied in your quality management system.
a.     This is fundamentally no different than how you manage sales and marketing to ensure that each of your regions is performing to expectations. If not—you adjust.
b.    The quality management system will be your best friend, and your best defense to regulatory inspectors—as well as personal injury attorneys.

The conversation was an absolutely engaging. The COO had never thought of GMPs in these terms.

He wanted to know how he could personally help to communicate the value of GMPs across the business.

The thirty minutes? As I left the room, the COO and the head of quality were still talking.

Sometimes one needs to reach out to the key players in the organization with a customized message, not drag them in to the same-old-same-old.

Mission accomplished. Intriguing.

The QA Pharm

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