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The Pharmaceutical, Biotech, and Medical Device industries are continuously hounded by tightening regulations, warning letters and fines.  With heightened FDA enforcement, most Life Sciences companies focus on meeting FDA regulations rather than improving the overall quality of their product. By focusing on improving quality from product inception, Life Sciences companies will naturally increase their compliance and profitability. 

Recently at the ISPE Delaware Valley event in September 2013, presenters offered the following methodology to increase profitability and compliance:

  1. Focus on the Consumer – Life Sciences companies that only focus on maintenance and calibration in terms of meeting FDA regulations often fall short in productivity, cost savings and efficiency compared to those that focus on creating a quality product for the consumer (from start to finish). By scheduling and completing necessary preventive maintenance activities with intentions to make a high quality product, companies will increase their bottom line, lower the number of emergency maintenance activities, downtime and missed production days and thus satisfy FDA regulations.
  2. Embrace Quality Assurance – To enhance overall product quality, Quality Assurance and maintenance personnel should work from the ground up on product development. Planning in the beginning stages of product development all the way through to planning maintenance and calibration activities will lead to improved efficiency, streamlined processes and smooth QA and maintenance integration. 
  3. Take Holistic Approach to Maintenance – By reevaluating and questioning “age-old” maintenance processes and work-flows, Life Sciences companies will continue to improve product output. More time on process and workflow design will lead to better predictability, improved manufacturing times, increased maintenance efficiency and fewer FDA warnings.

They spoke on shifting the compliance focus from requirement to opportunity and stated that “margin is mission” when focusing on process planning – and maintenance planning.  The ISPE presentation supported the concept that by focusing on planning and maintenance, companies can both improve their profitability and meet higher compliance when it comes to FDA inspections.