Developing ANDA Para II and III Drug Products via QbD (Quality by Design) : Innovation Management Case Study

​QbD, Innovation Management and Training Case Study

Problem: A multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) and Canada markets. Their employees weren’t trained in QbD methodology, hence needed both direction for product development as well as training in QbD.

Due Diligence:  A due diligence of product development work conducted so far, machinery,  manufacturing site, testing equipment etc. was conducted. A report comprising the QbD design thru implementation strategies and training programs was presented to the company’s management.

Solution: Appropriate training on QbD was given to the organization’s scientific team in R&D and operations. Training was provided as classroom coaching as well as online courses.

In addition to QbD implementation at design and development phase, a Risk Assessment protocol was developed for procurement of drugs and critical excipients, such that, the company can have the flexibility to choose vendors as needed.

Results Dashboard:

• All 3 product were developed with QbD compliance and launched on time.
• Additionally, QbD implementation reduced 10% cost on product analysis in its very first year of implementation.

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