QUALITY BY DESIGN: CHANGING OUTLOOK OF PHARMACEUTICAL DEVELOPMENT
Journal Title: International Journal of Pharmaceutical Sciences and Research (IJPSR) - Year 2019, Vol 10, Issue 9
Abstract
The concept of quality by design (QbD) justifies the saying that, quality is not an act, it is a habit. This innovative and systematic approach to pharmaceutical development based on scientific principles has been a breakthrough in developing quality products with a high level of reproducibility. The process of QbD is based on risk management which leads to a better understanding of the product and its manufacturing process, resulting in products with required quality, safety, and efficacy. As the quality and reliability requirements of today’s world are constantly increasing, QbD serves as an important tool in outperforming the global competition. This paper comprehensively discusses the concept of pharmaceutical quality by design, elements of QbD; quality target product profile (QTPP), critical quality attributes (CQAs), design space, control strategy, and lifecycle management. Application of QbD across various fields of pharmaceutical development including formulation development, analytical method development, phytopharmaceutical & biopharmaceutical product development are encompassed in the review.
Authors and Affiliations
S. Kalyan et al.
Keywords
Related Articles
- EP ID EP627093
- DOI 10.13040/IJPSR.0975-8232.10(9).4100-08
- Views 83
- Downloads 0
ASSESSMENT OF REPRODUCTIVE TOXICITY OF CONCOCTION OF ANDROGRAPHIS PANICULATA IN MALE WISTAR ALBINO RATS
Objective: To assess the reproductive toxicity of concoction of Andrographis paniculata in male Wistar albino rats. Methods: 18 male Wistar albino rats were divided into 3 groups with 6 animals in each group. Group 1 ser...
A COMPREHENSIVE REVIEW ON BENZOTHIAZOLE DERIVATIVES FOR THEIR BIOLOGICAL ACTIVITIES
Benzothiazole derivatives have a wide interest because of their diverse biological activities and clinical use. This bicyclic compound consists of a fusion of benzene nucleus with a five-membered ring comprising nitrogen...
AUTHENTICATION OF SEVEN INDIAN TRADITIONAL TYPES OF THE HERBAL DRUG TERMINALIA CHEBULA WITH SCIENTIFIC UPDATES – AN ADVANCED INSIGHT
The fruit of Terminalia chebula is an essential drug used in single and in many compound formulations of Indian traditional systems like Ayurveda & Siddha and Unani systems of medicine. This herbal drug is referred to as...
ASSESSMENT OF GREEN TEA EXTRACT ON TESTICULAR ACTIVITY IN STREPTOZOTOCIN-INDUCED DIABETIC SPRAGUE-DAWLEY RAT MODEL
Diabetes mellitus is a lasting metabolic disability regarding enhance etiology and permanent degenerating complications. Sexual abnormalities (Hypogonadism, infertility, etc.) are outfit a two of the discombobulate ingen...
AN IN-VITRO PHAGE THERAPY – IN OPPOSITION TO FOOD POISON ENGENDERED STAPHYLOCOCCUS AUREUS VIA PRECISE BACTERIOPHAGE FROM TIRUNELVELI DISTRICT, TAMIL NADU
Staphylococcus aureus, the facultative anaerobic and opportunistic Bacterium has been characterized as the pathogen with diversified molecular adaptability leading to the emergence of MDR. Advanced use of alternate antib...