A recent warning letter illustrates FDA's new emphasis in regards to training. The key point now seems to be not, "Are your people trained?" or "Do you have training records?", but are the procedures they are being trained in correct to begin with? Consider this comment:
“Our review indicates that there are on-going problems with your personnel failing to comply with procedures. . . . While you commit to revising your SOPs, it is FDA's expectation that your firm promptly correct all deficient procedures to ensure employees do not continue improper practices. To ensure quality of the drug product in aseptic operations, your personnel must employ strict discipline as they comply with adequate and appropriate procedures . . . Please provide a plan that evaluates your training program, specifically the program's effectiveness and your assurances of personnel compliance to aseptic processes prior to certification to work in an aseptic area.”
We can all agree that the cGMP’s require workers to have documented training. An issue that is being raised frequently in recent warning letters is the quality or correctness of the actual process as reflected in the official documents. A number of citations have appeared recently that are food for thought.
This one, for example, indicates that while training might be one solution, there are underlying procedural problems that must take precedence:
“Your firm’s response identifies plans to address the issues mentioned above by discontinuing poor practices, revising procedures, and providing additional employee training. In addition to those corrections, your firm should review all SOPs and clean room practices for the manufacturing of aseptic drug products to identify and address practices that would jeopardize drug product quality. In your response, please provide a time frame for completing this review.”
In summary, it is easier to promise to retrain than to review the process itself. The root question (and not a new one) that the Agency is asking is, what needs fixing—the employee or the procedure/ process as it is currently being performed? We need to first acknowledge that the underlying cause needs to be identified and addressed before we “fix the operator error” by re-training on a procedure that doesn’t work in the real world of the production floor.
