Open AccessAnalytical Quality by Design
Author(s) -
Márcia Cristina Breitkreitz
Publication year - 2021
Publication title -
brjac brazilian journal of analytical chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.131
H-Index - 6
eISSN - 2179-3433
pISSN - 2179-3425
DOI - 10.30744/brjac.2179-3425.editorial.mcbreitkreitz.n32
Subject(s) - quality by design , quality (philosophy) , product (mathematics) , risk analysis (engineering) , process (computing) , pharmaceutical manufacturing , manufacturing engineering , computer science , process analytical technology , quality management system , process management , good manufacturing practice , harmonization , new product development , quality assurance , quality management , business , engineering , operations management , work in process , marketing , medicine , mathematics , external quality assessment , acoustics , operating system , philosophy , geometry , epistemology , pharmacology , management system , physics , regulatory affairs
Throughout the 20th century, the notion of ‘quality’ underwent major changes. The concept of ‘Quality by Testing’, i.e. evaluating the quality of a product by testing it for some pre-defined parameters after completing the manufacturing process, started to be replaced by the enhanced approach of Quality by Design (QbD). In this concept, idealized by Joseph Juran [1], quality is initially conceived for the product, and then the product is manufactured and evaluated to reach that quality. Driven by the need to reduce costs and to encourage companies to improve their understanding of their products and manufacturing processes, pharmaceutical regulatory agencies, through the ICH (International Council on Harmonization), published the ICH Q8 guideline, highlighting the QbD strategy for pharmaceutical development [2]. This represented a significant step in replacing the existing quality paradigms in the conventional manufacturing of pharmaceutical products and paved the way to support development and production activities within a scientific, flexible environment, with a high level of quality, without the need for extensive regulatory surveillance. The higher level of understanding gained during development allows out-of-specification batches to be foreseen and ensures that the desired quality will be obtained at the end of the manufacturing process. The two pillars of the QbD concept are quality risk management and multivariate study of the outcomes (quality parameters) as functions of the inputs (materials, formulation and process inputs). At this point, Chemometrics emerged officially as a strategy to support the pharma regulatory requirements- the beginning of a joyful and long-life union.