For the last several years, there has been a push in the industry to take a systematic approach and design quality into your systems and processes by establishing up front requirements such as QTPP for process validation and ATP for analytical methods. Such an approach provides invaluable benefits to the public whereby, the manufacturer has a better understanding of the critical attributes that drive quality for the manufacturing and testing of the product and the required controls for those attributes.

When considering the above, one can ask whether such a concept should be applied to all of a company’s programs, including training. Should there be awareness of those attributes of the training program that are critical to ensuring that all individuals are trained and qualified for their respective job roles? Undoubtedly, most would say yes, but then what does that mean? This is where risk analysis can be invaluable, as one can process-map the complete onboarding and training program, including qualification and periodic re-evaluation versus 21 CFR 211.25:

Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.

So, throughout the training and qualification program, each process step can be evaluated in terms of criticality versus the above requirement and then to ensure that there are appropriate controls around that process step. For example, when onboarding and hiring a new employee (which can be considered a pre-requisite to the training), are there defined job role requirements? Are there minimum entry level requirements? How robust is the interview process (phone screening plus interviewing)? Is the screening/interviewing/onboarding process the same for all position types or is it modified depending upon the job role? For example, for a managerial position, is a presentation required? Ultimately, it is recommended that the hiring process is evaluated in the context of the ability to select the right individual for the role and, as such, are there sufficient controls whereby there is an acceptable level of risk of selecting the wrong individual?

Where 21 CFR 211.25 refers to training towards performing the assigned job function, I recommend there is separation of training and qualification and consider whether for that assigned function (depending upon its criticality) there needs to be a separate qualification step or whether, for example, is “read and understand” alone suitable? One should assess the risk of having someone execute the steps of the training program, being deemed as trained, but then failing to execute adequately against their job function. As such, when in the training program should one design a qualification step? Risk Analysis should be employed where the criticality of the function should be considered along with the ability to detect nonconformances downstream. For example, if someone was to be trained on generating a new test procedure or batch record, where there will be quality oversight through review and approval via the Quality Unit, then “read and understand” type training may be justified, but if the job function requires executing a test procedure or batch record, then based upon the risk/criticality, the training module may involve a “read and understand” along with a practical execution step in the presence of a qualified trainer. The inclusion of the practical aspect of training is common when working within an aseptic setting. The critical aspect is that the training program requires an evaluation for the level of training and qualification with a consideration of the associated risk for that job function for which they are being trained. For example, for training/qualification of laboratory personnel in a GLP setting, it is not uncommon to include the successful testing of blind samples. This “risk based upon approach” when designing your training program can also be applied to the requirements relating to requalification in terms of frequency and the required training/qualification that needs to be applied.

If you have any questions relating to the above topic, Lachman Consultants can help you! Please contact LCS@lachmanconsultants.com for support with this critical undertaking or click HERE.

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Paul Mason, Ph.D., is an Executive Director at Lachman Consultants who has more than 20 years of experience in the pharmaceutical industry. He is a Quality Control chemist experienced in sterile parenteral, API, and solid oral dosage forms. His experience spans finished dosage form, CMOs, and API (intermediates) manufacture support in both a Quality Control and Ana-lytical Development setting. Dr. Mason possesses a deep understanding of business strategy relating to drug research, development, quality assurance, quality control, CMC submissions, laboratory design, clinical and pre-clinical quality/analytical development support. In addition, he has provided expert scientific support for the timely resolution of complicated scientific is-sues raised by FDA application reviewers.