Stages 2 And 3 QbD Validation Strategies For Nonsterile Solid Dosage Forms

By Anil M. Doshi, R.Ph, Ph.D, President, Infinity Pharmaceutical Consulting

In my previous communication in February, I provided an overview of stage 1 QbD validation strategies for process design for nonsterile solid dosage forms. In this article, I will continue to highlight strategies for validation prior to release of a commercial product (stages 2 and 3).

Stage 2 is referred process qualification, which includes pharmaceutical drug products at a stage prior to commercialization or prior to submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).  In this stage, it must be demonstrated that the process for manufacture of a drug product is consistent and can produce drug products that are compliant with the Food and Drug Administration’s requirements for filing.