Quality by Design (QbD) Approach to Generic Transdermal or Topical Product Development

摘要

As noted recently, FDA has issued several guidance documents to encourage companies to implement components of Quality by Design (QbD) into various phases of product lifecycles, with an emphasis on product development. Companies are expected to incorporate basic QbD elements in ANDA product filings1 and transition to more complete QbD filings as industry and regulatory agencies sync knowledge gained from successful and unsuccessful experiences. As a starting point to guide companies in this endeavor, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.1"4 ICH Q8(R2) describes the scope and principles of QbD and suggests examples and methodologies to enhance product and process knowledge in formulation and process development; ICH Q9 provides guidance to implement quality risk management into product development by using scientific knowledge to make risk assessments; ICH Q10 provides guidance for using ICH Q8 and ICHQ9 principles in regulatory strategies.1 FDA defines QbD as "A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management." In addition, FDA has published 2 excellent, comprehensive examples for implementing QbD at all stages of development of immediate and modified release dosage forms.