Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Short Communication Volume 4 Issue 3

Are We Doing Justice to the ‘Quality by Design’?

Dhawal Chobisa1,2*

1IPDO Innovation Plaza, Dr. Reddy’s Laboratories, Hyderabad, India
2Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, USA

*Corresponding Author: Dhawal Chobisa, IPDO Innovation Plaza, Dr. Reddy’s Laboratories, Hyderabad, India and Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, USA.

Received: November 15, 2019; Published: February 08, 2020

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Abstract

  ‘Building quality into pharmaceutical drug products’ instead of ‘end product testing’ was focus of implementation of quality by design (QbD). Quality pharmaceutical drug products should be able produce desired pharmacological effects for intended time. Sustained manufacturing processes lead to decreased variability and reliable drug products quality. Quality by design and six sigma framework offers various tools and techniques to achieve the goals. A few techniques such as design of experiments, have been explored widely by researchers. However, various techniques are yet to be used for effective drug product development. This paper briefly describes about a few tools viz. quality function deployment (QFD), failure mode and effects analysis (FMEA), and process capability analysis, that can be used at various stages of drug products development.

Keywords: Quality by Design (QbD); Pharmaceutical Drug Product Development; Design of Experiments (DoE)

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References

  1. Beg S and Hasnain MS. Pharmaceutical Quality by Design, Academic Press (2019).
  2. ICH Q8(R2)—Pharmaceutical development, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009).
  3. ICH Q9—Quality risk management, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005).
  4. ICH Q10—Pharmaceutical quality systems, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2008). 
  5. A Guide to Pharmaceutical Quality by Design, GxP lifeline (2019).
  6. Google scholar.
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Citation

Citation: Dhawal Chobisa. “Are We Doing Justice to the ‘Quality by Design’?". Acta Scientific Pharmaceutical Sciences 4.3(2020): 01-02.



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