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Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

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An Erratum to this article was published on 01 July 2008

Abstract

Purpose

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality.

Materials and Methods

The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone.

Results

The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include:

  • Defining target product quality profile

  • Designing product and manufacturing processes

  • Identifying critical quality attributes, process parameters, and sources of variability

  • Controlling manufacturing processes to produce consistent quality over time

Conclusions

Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

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Notes

  1. This may be defined as material attributes.

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Acknowledgment

The authors would like to thank Drs. Gregory Amidon, Yihong Qiu, John Strong, Alan Parr, Mansoor Khan, Vincent Vilker, Robert Lionberger, Andre Raw, Lai Ming Lee, Lawrence Sau Lee, Wallace Adams, Doan Nguyen, Michelle Bryden, Gary Buehler, Helen Winkle, and Janet Woodcock for their valuable suggestions.

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Authors and Affiliations

  1. Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland, 20855, USA

    Lawrence X. Yu

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  1. Lawrence X. Yu
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Correspondence to Lawrence X. Yu.

Additional information

The views presented in this article do not necessarily reflect those of the Food and Drug Administration.

An erratum to this article can be found at http://dx.doi.org/10.1007/s11095-008-9667-3

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Yu, L.X. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharm Res 25, 781–791 (2008). https://doi.org/10.1007/s11095-007-9511-1

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