There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases they are made when new company standards are deployed to remain current with changing regulatory requirements and current industry practices. Still other improvements are made to support the changing mission and product portfolio of the business.

Whatever the driver may be, a mindful approach must be taken when revising the quality system to ensure that the organization is capable of operating and sustaining the system. Unfortunately, improvements are often viewed as an exercise in writing standard operating procedures without considering the factors that help to ensure the improvement implementation is successful.

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