Abstract

DoE & Development of Design Space for Pharmaceutical Product Development as per QbD with alive cases of Solid Orals, Liquid Orals, Semisolids & Parenteral Dosage Forms

Shivang Chaudhary, Formulation Engineer & Patent Attorney, Indian Institute of Management Ahmedabad

“Quality doesn’t costs, it always pays” & “Quality does not happen accidently”. Quality must be designed in by planning, not tested in afterwards. In this era of 20-20, a universal FMEA-DoE-PAT based intellectual of “enhanced” quality by design (QbD) has been gradually permeating into the mindset and practice in the pharmaceutical industry, largely attributable to the recent stimulus by the US-FDA, EU-EMEA, Japan-PMDA & ICH. And QbD is predominantly dependent on how effectively & extensively quality risk management has been conceded out by FMEA (FAILURE MODE EFFECTIVE ANALYSIS) which decides which risk, involved in either formulation and/or manufacturing processes, should get first priority among all based upon Severity*Probability*Detectability of risk. By and large, SEVERITY of risks cannot be reduced, but PROBABILITY of risk occurrence can be abridged by planning systematic series of experiments by DESIGNING OF EXPERIMENTS (DoE) to generate safe & optimized ranges of CMAs & CPPs with respect to desired CQAs par overlaid DESIGN SPACE, where all the desired CQAs are met simultaneously. While DETECTABILITY of risk can be increased through implementation of PROCESS ANALYTICAL TECHNOLOGY (PAT) as per predefined control strategy at commercial manufacturing stage by online analyzing and controlling manufacturing through the timely measurement of critical quality and performance attributes of raw and in-process materials or in-process parameters to control quality of finished product. This session will help to gain technical experience through live demonstration on how to utilize tools of QbD i.e. DoE & PAT & how to implement it systematically & effectively during development & manufacturing of Solid Oral dosage forms (Tablets/ Capsules) as well as Liquid Orals/ Semisolids (Solution/ Suspension/Emulsion) & Parenteral/ Sterile Dosage forms i.e. Eye/Ear/Nasal Drops, SVP & LVP. The agenda is especially designed for scientists and technical professionals working in pharm