Quality by Design: A Review on Modern Approach for Quality of Pharmaceuticals

Autor: K Vanitha, Shastry, Sheetal, Y. Navya
Jazyk: angličtina
Rok vydání: 2019
Předmět:
DOI: 10.5281/zenodo.3402724
Popis: Quality by design (QbD) is the present-day approach to ensure the safety and efficacy of pharmaceuticals. In this review, the quality by design is described and some of its elements are identified to ensure quality of pharmaceuticals. Process parameters and quality attributes are identified for each unit operation. The benefits, possibilities, and steps engaged in quality by design of pharmaceutical products are outlined in this article. The quality guidelines Q8, Q9, Q10 given by ICH for pharmaceutical development, quality risk management, pharmaceutical quality systems respectively, gives application of quality by design in pharmaceutical development and their manufacturing. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product with good quality. Measures should be taken to add or enhance the quality of product throughout its development. It includes the Quality target product profile, critical quality attributes and other key aspects of Quality by Design. QbD also gives the comparison between quality of product by end-product testing and quality of product by quality by design. Quality by Design is the aspect explained and given in international conference for harmonization.
{"references":["(August 2009) \"International conference on harmonization of technical Requirements for registration of pharmaceuticals for human use, Q8: Pharmaceutical development\",","ICH Harmonized Tripartite Guidelines (November 2005), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q9: Quality Risk Management,","(2007), \"Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines\", International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.","Food and Drug Administration CDER (1995), \"Guidance for industry: Immediate release solid oral dosage forms scale-up and post approval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation\",","Leuenberger H, Puchkov M, Kraus Bauer E, Betz G (2009), \"Manufacturing pharmaceutical granules, Is the granulation end-point a myth\", Powder Technology, Volume 189, pp. 141–148.","Miller CE (2006), \"Chemo metrics and NIR: A match made in heaven\", Am. Pharm. Rev. Food and Drug Administration CDER, Guidance for industry, Q8 pharmaceutical development, pp. 41–48.","Food and Drug Administration CDER (1997), \"Guidance for industry: Non sterile semisolid dosage forms scale-up and post approval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation\",","Food and Drug Administration CDER (2004), \"Guidance for industry: Changes to an approved NDA or ANDA\",","Woodcock J (2004), \"The concept of pharmaceutical quality\", American Pharmaceutical Review, pp. 1–3.","Food and Drug administration, Office of Generic Drugs white paper on Question-based review: http://www.fda.gov/cder/OGD/qbr.html"]}
Databáze: OpenAIRE
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