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.
DME’s 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.
The DME Facility Focus survey provided further insights into how manufacturers are coping with these challenges. When asked what new technologies they have introduced as part of a facility modernization project, ranked from most common to least common technology, participants responded as follows:
- Process automation
- Clean-in-place (CIP) improvement
- Continuous manufacturing
- Modular construction
The survey findings suggest that manufacturers choose to selectively introduce new technology in aging facilities where the potential benefits significantly outweigh the pain points (e.g., total cost and risk due to many aspects of implementing a change). In legacy facilities, a new technology is strategically adopted in areas that yield the greatest benefit and where it is relatively easy to demonstrate that the change will not adversely affect product quality.
Excerpt from Markitects client, DME, as seen in PharmTech.com