PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 287

its other role, protective clothing is needed to protect personnel from harmful
materials such as highly toxic chemicals to which they may be exposed in the
working environment. The assessment should take into consideration the type and
the level of protection required for each manufacturing process. This information
will help decide the types (e.g., body suit, hair bonnets, gloves, mask, booties,
and respirators) of protective gear and the right materials of construction (e.g.,
latex, Tyvek ® , woven cotton, polyester). The goal would be to have the maximum
protection needed and yet provide comfort and allow for maneuverability.
It is important to consider whether the gear needs to be protected from environ-
mental contamination before use, while being donned or while in use. The need
to define the incoming packaging, storage area conditions, as well as proper don-
ning and operating techniques while being used are worth assessing. To maintain
control, personnel must be trained in the proper donning and operating techniques
and these practices routinely monitored.
11.2.6.3 People Interactions Every step where personnel are interacting with
in-process materials or products must be assessed to determine the risk of intro-
ducing contamination through these interactions. Every effort must be made to
mitigate the risk through a number of options such as substitution by automation
or barriers or strictly enforced technique and practices.
11.2.6.4 Training Regulatory agencies want to know if manufacturers have
the right people doing the right jobs and are well trained to perform their job
tasks [19]. They want manufacturers to take training seriously because product
quality is at risk. Often, failure to train comes up as an issue in investigations
or deviations. The question arises whether the personnel had the appropriate
training so they can perform their functions properly or whether the training
was effective. Employees must be adequately trained, their training managed,
recorded, and monitored; and their training records evaluated all in an effort to
determine if the training program is producing the intended results.
When an operator error occurs, it is of utmost importance to first find the root
cause of the problem. Retraining an operator on a procedure may not substitute as
a fix for other deep-rooted manufacturing issues. It must be determined whether
the root cause is the employee, the procedure, or the process as it is being
performed. Retraining on a procedure that may not work may not fix operator
error. Having said that, good training and training programs are key to operational
success and minimizing the risk to product quality.
11.3 CASE STUDY: MICROBIOLOGICAL CONTROL IN NONSTERILE
MANUFACTURING
As a general observation, the risk of microbiological contamination during the
manufacturing of nonsterile products has been an area that has not been well
defined [20]. Typically, environmental control systems and monitoring data have