William Morkel, BSc
Director of Quality and Compliance, dicentra

If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, lack of proper training would be at or near the top of the list (second perhaps only to a lack of effective change control). Whenever I am called to investigate an out-of-specification result one of the first questions I ask is, “Who was the technician, for how long have they held the position, and what training did they receive?”

Companies that manufacture, package, label, or import drugs, NHPs, or dietary supplements for sale in Canada and the U.S. must ensure that their staff is trained in Good Manufacturing Practices; it is a regulatory requirement. In fact, if employees are not adequately trained, a company can be charged with selling an adulterated product under the Food and Drugs Act on that basis alone. But legal ramifications aside, proper training makes good business sense. Employees who are properly trained make fewer errors and are better equipped to handle errors/incidents when they do occur.

A good GMP training program should be comprehensive, covering all GMP elements as they apply to the company’s activities in general and to the trainee’s position in particular. The program should ensure that new employees receive initial GMP training and that all existing employees receive ongoing GMP training, usually conducted on an annual basis. Companies, moreover, should have a way to assess the effectiveness of their training program. This is typically done by administering a written quiz.

If one finds employees making repeated errors, then the effectiveness of the program should be questioned. Too often, when a non-conformance or out-of-specification result occurs, the root cause is attributed to “employee error” and the corrective action implemented is to simply “re-train employee.” This is a quick and convenient fall-back when one is pressured to wrap up a QA investigation quickly. Government inspectors, however, have grown wary of this trend. Now, when an auditor sees “re-train” as a documented response to a non-conformance, they are asking, “Well, if your training didn’t work the first time, what makes you think it will work now? What are you doing to ensure that you have in place an effective GMP training program?”

GMP training can be conducted in-house or a company can rely on the services of a third party, as long as the trainer, whether internal or external, is qualified. The training program must be in the form of a formal, controlled, written procedure. As with any GMP activity, any and all training must be documented (training logs, certificates, attendance sheets, etc.). Rest assured, an inspector visiting your site will ask to see these records.

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dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com