Quality by Design: A new practice for production of pharmaceutical products

  • anuj malik M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Gourab Gochhayat M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Md Shamshir Alam M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Manish Kumar M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Preeti Pal M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Raj Singh Department of Biotechnology, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207
  • Vipin Saini Maharishi Markandeshwar University, Solan (H.P.) - 173 229

Abstract

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

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Author Biographies

anuj malik, M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Gourab Gochhayat, M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Md Shamshir Alam, M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Manish Kumar, M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Preeti Pal, M. M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Raj Singh, Department of Biotechnology, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Department of Biotechnology, Maharishi Markandeshwar (Deemed to University), Mullana, Ambala, Haryana-133207

Vipin Saini, Maharishi Markandeshwar University, Solan (H.P.) - 173 229

Maharishi Markandeshwar University, Solan (H.P.) - 173 229

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How to Cite
malik, anuj, Gochhayat, G., Alam, M. S., Kumar, M., Pal, P., Singh, R., & Saini, V. (2019). Quality by Design: A new practice for production of pharmaceutical products. Journal of Drug Delivery and Therapeutics, 9(1-s), 416-424. https://doi.org/10.22270/jddt.v9i1-s.2370