Quality by Design (QbD) principles are now fast migrating to the analytical laboratory and the generic pharma community offered up some excellent real-life examples last week at the IFPAC annual meeting in Baltimore, MD.
The session was chaired by Lawrence Yu, FDA which helped give this session the attention it deserved.
A senior Director at Teva, described how statistically rigorous QbD principles can be put into practice in order to provide more robust method development, validation and transfer.
Also, both Amneal Pharmaceuticals and Prinston Pharmaceuticals continued the theme with very comprehensive case studies of how QbD processes may be applied to formulation development; walking the audience through specific immediate release and modified release oral solid dose case studies, respectively.
At the close of the “QbD in the generic industry” session a reviewer at the FDA’s Office of Generic Drugs (OGD) provided some very illuminating statistics pertaining to ANDA filings over the last several months. It was reported that over 80% of the ANDA’s in January 2013 contained “a significant number of QbD elements” within the filing compared with just 24% in June 2012. This is a marked increase in the number of filings including QbD, which is in alignment with and testament to the FDA’s recommendations regarding ANDA and QbD reporting.
In other sessions novel technologies were discussed to solve new or existing analytical challenges. In one such session, focusing on particle identification in pharmaceuticals, the challenges of developing nasally administered formulations with the desired bioequivalence (BE) were discussed. The US Food and Drug Administration presented new automated particle imaging and identification technology that help solve these challenges.
The Morphologi G3-ID from Malvern Instruments was demonstrated to be a new product that could help with the BE characterization of nasally administered drugs. It does so by removing the subjectivity, normally encountered, when measuring particle size distribution of suspension products. The Morphologi G3-ID facilitates the creation and storage of fully automated Standard Operating Procedures (SOPS) for particle morphological and chemical characterization. The system also provides elegant data archival features.