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BIO INNOVATION NOTES REPORT LIFESCIENCELEADER.COM APRIL 2014 20 If you want to learn more about the report, please go to bioplanassociates.com E R I C L A N G E R President and Managing Partner BioPlan Associates, Inc. BEST PRACTICES IN QUALITY MANAGEMENT: INDUSTRY'S APPROACH TO QUALITY INITIATIVES By E. Langer Many firms have already implemented a range of initiatives, from QbD to process modeling. Best Practices In Quality Management: Industry's Approach To Quality Initiatives uality management is an increasingly important focus for biopharmaceutical man- ufacturers looking to avoid production problems and failures. And it's increasingly becoming a multifac- eted, industrywide concern as regulators take a closer look. With this in mind, it's useful to see how the industry is approaching quality management in terms of the initiatives being pursued. BEST PRACTICES IN COMBATING BATCH FAILURE Preliminary results from our latest industry survey (11th Annual Report and Survey of Biopharmaceutical Manufacturers) indicate that for roughly four in 10 respondents the most recent batch failure occurred during the previ- ous six months. That includes more than one in 10 saying it occurred within the prior month. On average, overall batch failures occurred once every 59.7 weeks. This compares to one failure every 53.3 weeks in 2013 and one every 51.1 weeks in 2009. So improvements are clearly being made at extending the industry's average time between batch failures. To tackle batch failures, companies are taking steps such as: improving their process design and reducing process steps using improved, more robust, equipment adopting training programs for implementing single-use equipment resolving supply chain issues using process monitoring and process analytical technology (PAT) gaining experience in preventing contamination adopting newer cell lines and genetic engineering technologies. FUTURE INITIATIVES We also sought to quantify some of these efforts by presenting respondents with a list of 12 quality initiatives, asking them to identify 1) which they are cur- rently implementing and 2) which they are planning to implement within the next 12 months. Our preliminary results indicate that among the 12 relevant qual- ity initiatives the industry is primarily focused on: risk management/analysis (64.5 percent currently implementing) risk analysis/failure mode effects analysis (FMEA) (65.8 percent) platform manufacturing processes (64.4 percent) These are similar to the rates we found in last year's study for what's currently being implemented. That plateauing may suggest these initiatives are now broadly implemented, and fewer facilities are in the planning stages of implementation, compared with last year's survey. So far this year, we are also seeing an uptick in implementation of initiatives such as design space/DOE (design of experiment) (58.9 percent, from 52.1 per- cent in 2013) and QbD (quality by design) (52.1 percent, from 43.7 percent in 2013). However, most of the other initiatives we measured have remained relatively steady compared to last year. As more facilities actually implement these initiatives, of course, fewer will 0 4 1 4 _ R e p o r t s _ B I . i n d d 1 0414_Reports_BI.indd 1 3 / 2 1 / 2 0 1 4 1 2 : 2 1 : 4 3 P M 3/21/2014 12:21:43 PM