Biomedical Engineering Reference
In-Depth Information
in isolation, but requires stepping back and gaining a full picture, linking the
risks from the different process steps to the full manufacturing process, and then
looking at all the manufacturing processes together. This offers a snapshot of all
the risks, the overall control, and residual risk the company is faced with that
either cannot be further controlled or mitigated or that the company decided it
cannot mitigate. Further, it is important to realize that the risk analysis is not a
one-time task but a continual process that requires a link to change control and
the investigation systems so that the risk analysis is updated when changes are
required.
What could be the benefit of risk management in pharmaceutical manufactur-
ing? The benefits could include the following:
• fewer compliance issues such as recalled product, reduction in customer
complaints;
• a well-trained and informed staff;
• increased process efficiencies resulting in cost savings;
• building trust with regulatory agencies; and
• improved assurance of product quality that reduces the risk to the patient.
The use of risk management principles and tools has a clear sense of purpose
in pharmaceutical manufacturing. It fosters product and process knowledge and
it sets direction and priorities during product development, problem solving, and
process improvement activities. It provides for a proactive strategic approach to
determine how best to engineer the manufacturing process with the appropriate
process controls and monitoring so that product quality is achieved reliably and
consistently from batch to batch. We used HACCP as the tool of choice in the
example for assessing microbial control in solid manufacturing; however, other
types of risk assessment tools could have been used for this example .Likewise,
the HACCP tool could be applied to other types of manufacturing processes.
The benefit of HACCP is that the tool fits well into the life cycle approach. With
HACCP, the hazards are always being looked at, critical parameters and limits
monitored, and adjustments made to improve the process and control strategy.
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