Progress in Medical Sciences. 2022;
6(5):(148-202)
A Technical Overview of the Pharmaceutical Development Process and Best Practices
Rohit Singhal
Abstract
The pharmaceutical development process is the foundation for the production of safe, effective, and highquality
medications. This article explores the complex stages of pharmaceutical development, starting with
the significance of selecting appropriate drug substances and excipients, formulation development, and
establishing robust manufacturing processes. The integration of Quality by Design (QbD) principles and
advanced risk management strategies is discussed as a means to optimize development and ensure regulatory
compliance. By adhering to the guidelines outlined by the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use considerations (ICH) guideline
Q8 (R2) on pharmaceutical development, pharmaceutical companies can enhance product quality, reduce
variability, and ensure the consistent delivery of therapeutic products to the market.