The Balancing Act: Maintaining Aging Facilities vs. Facility Modernization
As seen in PharmTech.com
by David M. Marks, President, DME
Facility modernization can be a complex and difficult process even under the best of circumstances, but when one factors in the global regulatory hurdles in pharmaceutical manufacturing, the challenges are significantly greater.
However, the reality of aging facilities that must be maintained in a state that is reliable, efficient, and compliant with current good manufacturing practice cannot be avoided. Successful implementation of change must be executed with a good understanding of the challenges associated with introducing new technology and an execution strategy that proactively achieves strategic outcomes.
In an industry-wide survey of the life sciences sector conducted by DME in partnership with INTERPHEX, industry insiders—those in engineering and operations roles—were asked what they believed was the biggest obstacle to the adoption of new technologies for facility modernization. The majority (62%) of respondents indicated that regulatory challenges (process validation or regulatory acceptance) were their biggest concerns. The remaining survey participants cited the biggest obstacle as process development requirements (18%), lack of industry standards (12%), and insecure vendor supply chain (5%). Those with “other” responses (4%) most frequently indicated their belief that general industry conservatism is the biggest obstacle.
Unintended consequences Our findings are consistent with a recent survey by the Parenteral Drug Association (PDA). In their public call to action, the PDA taskforce went so far as to link the current post-approval change environment to drug shortages and deferred process improvement.