Open AccessPharmaceutical product development: A quality by design approach
Author(s) -
K. Pramod,
Marie Tahir,
Naseem A. Charoo,
S. H. Ansari,
Javed Ali
Publication year - 2016
Publication title -
international journal of pharmaceutical investigation
Language(s) - English
Resource type - Journals
eISSN - 2230-973X
pISSN - 2230-9713
DOI - 10.4103/2230-973x.187350
Subject(s) - quality by design , risk analysis (engineering) , pharmaceutical industry , quality (philosophy) , critical quality attributes , pharmaceutical manufacturing , computer science , product (mathematics) , harmonization , process validation , new product development , food and drug administration , biochemical engineering , process (computing) , process management , manufacturing engineering , business , medicine , engineering , pharmacology , marketing , mathematics , philosophy , physics , geometry , epistemology , acoustics , operating system
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.