Open AccessQuality By Design: A Review
Author(s) -
S Savitha,
K. Sita Devi
Publication year - 2022
Publication title -
journal of drug delivery and therapeutics
Language(s) - English
Resource type - Journals
ISSN - 2250-1177
DOI - 10.22270/jddt.v12i2-s.5451
Subject(s) - quality by design , quality (philosophy) , quality assurance , computer science , pharmaceutical manufacturing , product (mathematics) , risk analysis (engineering) , manufacturing engineering , qa/qc , software quality control , product design , reliability engineering , biochemical engineering , process management , new product development , business , engineering , operations management , medicine , marketing , mathematics , pharmacology , software quality , philosophy , software , software system , external quality assessment , software construction , geometry , epistemology , software development , programming language
Quality by Design is the most recent quality-related trend in pharmaceutical manufacturing (QbD). This paper discusses Pharmaceutical Quality by Design (QbD) as a way to guarantee high-quality pharmaceuticals. Details about Quality by Design are given in addition to a list of its components. The quality parameters and attributes of each unit operation are unique. Pharmaceutical products can benefit from Quality by Design and the steps that can be taken to implement it. High-quality pharmaceuticals and their manufacturing processes form the core of pharmaceutical R&D. It is impossible to verify the quality of a product because this document includes a breakdown of the product's quality profile and the most important aspects of Quality by Design. Comparing the quality of various products can be done in two ways: through Quality by Design and end-product testing (QbD). Quality by Design is based on the ICH Guidelines. ICH guidelines govern the development of pharmaceuticals and the implementation of quality assurance systems. Pharmaceutical development and production can benefit from Quality by Design (QbD).
Keywords: Concept & background of QbD, Traditional vs QbD Approach, Key elements, PAT, Challenges, Current & Future perspective.