Pharmaceutical product development: A quality by design approach.
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.
College of Pharmaceutical Sciences, Government Medical College, Kozhikode, Kerala, India.
Kannissery
K
Pramod
Biogenero Labs Pvt Ltd., Unit No.1, Sy. No 179, C.K Palya, Hullahalli, Sakalvara Post, Bangalore, India.
M Abu
MA
Tahir
Zayn Pharmaceuticals, Unit No. 2H-05-320, Floor No.5 Bldg No.2, Plot No. 550-554 J&G, DMCC, Dubai, United Arab Emirates; AlFalah Life Sciences Pvt. Ltd. 27-Wathora, Budgam-191113, Jammu and Kashmir, India.
Naseem A
NA
Charoo
Department of Pharmacognosy and Phytochemistry, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi, India.
Shahid H
SH
Ansari
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi, India.
Javed
J
Ali
Design of experiments; QbD; Quality by Design; design space; process analytical technology; risk assessment