Pharmaceutical quality by design: product and process development, understanding, and control.
OBJECTIVE
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.


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.
Yu
Lawrence X
LX
Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland 20855, USA. Lawrence.Yu@fda.hhs.gov [corrected]
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003257:Consumer Product Safety; D004304:Dosage Forms; D004339:Drug Compounding / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D016568:Drugs, Generic / Q000008:administration & dosage / Q000737:chemistry / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000592:standards*
D004304:Dosage Forms; D016568:Drugs, Generic