Chemistry Reference
In-Depth Information
recent examples of training deficiencies in actual FDA 483 warning letters [24].
Training is an important component of GMP, and to satisfy GMP requirements,
training must be focused [12,14]. The two areas that are most relevant from a regu-
lated laboratory job function standpoint are the training requirements themselves
and the training that relates directly to the job function. From a GMP requirements
standpoint, the training objective should be to enable people to make decisions and
interpretations of the guidelines or to ask appropriate questions when there is a lack
of clarity regarding any situation within the work environment. For training that
relates directly to job function or tasks, the objective is to teach the things personnel
need to know to perform their job in an effective manner. But how can these training
objectives be accomplished and be meaningful in today's work environment, where
everyone feels the pressure to accomplish more, faster? The addition of training as a
requirement seems to be an added burden that could further stress an organization or
lab. However, when training is done correctly and given serious thought, it can help
meet the requirements of GMP as well as benefit the lab by increasing productivity.
Therefore, an investment in training is a positive business decision that enables a
company to meet the requirements to function in a compliant environment.
Laboratory training for compliance purposes is achieved by ensuring that person-
nel are trained to understand the regulations to the point that they impact the lab and
to accomplish various functions in the lab, such as operating instrumentation.
To help an employee understand the GMP regulations that impact the lab, the
training should be specific to an individual's function and focus within the lab. It
is of little value to train or educate an employee on all of the regulations if there
is no impact on the job that the person fulfills everyday. This thought is obviously
mitigated by the idea that there should be a basic level of training that introduces
the employee to the company's philosophy and standards for compliance. A new
employee might think he is aware of the standards that are acceptable from previous
experience. However, this experience might not be relevant in his new environment.
It is also true that if only a general focus is given to training, there is more likelihood
of causing confusion or clouding of issues. The focus of regulatory training should
enable a person to ably and effectively meet the requirements and to understand what
those requirements mean from their employer's point of view. The focus should be
on their daily needs.
At the same time, there should be someone who has a high-level total-picture
view to ensure there is continuity for the overall regulatory or compliance program
and that it is aligned with the rest of the organization. This person needs more com-
plete training on the GMP requirements to meet business objectives, and could be a
manager within the lab or a quality representative for the company focusing on the
lab. This person could also be someone whom the technicians turn to for assistance
with questions that are beyond their scope or current training level. The next level
of training is related to accomplishing the given functions in the lab, such as operat-
ing instrumentation and signing off that analyses were performed as required. It is
important to note that it is not enough just to be able to push buttons to make instru-
mentation function and follow the standard operating procedures. The requirements
put pressure on lab management and personnel to understand the background or
basics of any analytical technique that is used in the lab. These analytical techniques
