Quality by Design: A new practice for production of pharmaceutical products
This is the advanced approach for development of pharmaceutical product with full range and specified limits of variables during procurements, storage and manufacturing process with a qualification, at desired level of quality within the limits of low and higher values of variables to ensures the Pharmaceutical product Quality by design (QbD) of manufacturing a finished product. The Quality by Design is depicted and a portion of its components recognized and process parameters with quality characteristics are identified for every unit activity. Advantages, openings and steps engaged with Quality by Design of Pharmaceutical items are depicted. The point of the pharmaceutical advancement is to plan a quality item and it’s assembling procedure to reliably convey the proposed execution of the item. Quality can't be tried into items however quality ought to be worked in by outline. It incorporates the Quality target item profile, basic quality traits and key parts of Quality by Design. It likewise gives correlation between item quality by end item testing and item quality by Quality by Design. The establishment of Quality by Design is ICH Guidelines. It depends on the ICH Guidelines Q8 for pharmaceutical improvement, Q9 for quality hazard administration, Q10 for pharmaceutical quality frameworks. It moreover gives utilization of Quality by Design in pharmaceutical improvement and assembling of pharmaceuticals.
Keywords: Quality by Design, Design Space, Target Product Quality Profile, Critical Quality Attributes
3. Woodcock J, The concept of pharmaceutical quality. American Pharmaceutical Review, 7(6), 2004, 10–15.
4. Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
5. Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2007.
6. Lionberger RA, Lee LS, Lee L, Raw A ,Yu LX, Quality by design: Concepts for ANDAs, The AAPS, 2008; 10:268–276.
7. FDA Guidance for Industry and Review Staff: Target Product Profile – A Strategic Development Process Tool (Draft Guidance).
8. Lawrence X. Yu (2006) Director of science. “Implementation of Quality by Design”, Question based review.
9. Anat IB (2013) QbD Strategy Leader, “Bud implementation in Generic Industry: Overview and Case-Study” IFPAC JAN.
10. Avellant J (2008) “Why Quality by Design?” Expert Brefings pp. 1-12.
11. Roy S, “Quality by Design-Holistic concept of concept of building quality in pharmaceuticals”. Int J Pham Biomed Res 2012; 3:100-108.
13. Q8 (R1): Pharmaceutical Development, Revision 1, ICH Harmonized Tripartite Guidelines, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2007.
14. Callis JB, Illman DL, Kowalski BR, Process analytical chemistry. Analytical Chemistry, 1987; 59:624A–637A.
15. Yu LX, Pharmaceutical quality by design: Product and process development, understanding, and control. Pharmaceutical Research, 2008; 25:781–791.
16. Munson J, Gujral B, Stanfield CF, A review of process analytical technology (PAT) in the U.S. pharmaceutical industry. Current Pharmaceutical Analysis, 2006; 2:405–414.
17. Leuenberger H, Puchkov M, Krausbauer E, Betz G, Manufacturing pharmaceutical granules, Is the granulation end-point a myth, Powder Technology, 2009; 189:141–148.
18. Miller CE, Chemometrics and NIR: A match made in heaven, Am. Pharm. Rev. Food and Drug Administration CDER, Guidance for industry, Q8 pharmaceutical development; 2:41–48, 2006.
19. Nasr M. Risk-based CMC review paradigm, Advisory committee for pharmaceutical science meeting, 2004.
20. Food and Drug Administration CDER. 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, 1995.
21. Food and Drug Administration CDER. Guidance for industry: Modified release solid oral dosage forms scale-up and post approval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, 1997.
22. Food and Drug Administration CDER. 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, 1997.
23. Food and Drug Administration CDER. Guidance for industry: Changes to an approved NDA or ANDA, 2004.
24. Woodcock J, The concept of pharmaceutical quality. American Pharmaceutical Review, 2004, 1–3.
25. Food and Drug Administration, Office of Generic Drugs White Paper on Question-based Review: http://www.fda.gov/cder/ OGD/QbR.htm.
26. Food and Drug Administration, Guidance for industry, Q6A specifications for new drug substances and products: Chemical substances, 1999.
27. Nasr M, FDA’s quality initiatives: An update, http://www.gmpcompliance. com/daten/download/FDAs_Quality_Initiative.pdf, 2007.
28. IBM Business Consulting Services, Transforming industrialization: A new paradigm for pharmaceutical development, www-935.ibm.com/services/us/imc/pdf/ge 510– 3997-transforming-industrialization.pdf, 2006.
29. Food and Drug Administration: http://www.fda.gov/ohrms/dockets/ac/06/minutes/2006–4228m1.pdf, 2006.
30. Zhang H, Lawrence X, Dissolution testing for solid oral drug products: Theoretical considerations, American Pharmaceutical Review, 2004, 26–31.
31. Radeke CA, Glasser BJ, Khinast, JG, Large-scale powder mixer simulations using massively parallel GPU architectures, Chemical Engineering Science, 2010; 65:6435–6442.
32. Radl S, Kalvoda E, Glasse BJ, Khinast JG, Mixing characteristics of wet granular matter in a bladed mixer, Powder Technology, 2009; 200:171–189.
33. Rathore AS, Roadmap for implementation of Quality by Design (QbD) for biotechnology products, Trends in Biotechnology, 2005; 27:546–553.
34. Rathore AS, Brenning RCD, Cecchini D, Design space for biotech products. Biopharm International, 20, 36–40.
35. Rathore AS, Winkle H, Quality by Design for biopharmaceuticals. Nature Biotechnology, 2009; 27:26–34.
36. Remy B, Glasser BJ, Khinast JG, The effect of mixer properties and fill level on granular flow in a bladed mixer. AIChE Journal, 2010; 56:336–353.
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