This article presents an overview of the implementation of key elements (Target Product Profile, Critical Quality Attributes, design space and control strategy) of Quality by Design (QbD) — a systemic approach in the case of generic drugs. The basis for this concept is that advanced understanding of variables affecting generic drug (product) quality, either obtained through historical operation or demonstrated through process modelling, justifies the replacement of the traditional process targets with acceptable operational ranges. This article also describes the steps involved in the development of generic drugs, steps through which the QbD concept can be applied, and the opportunities for and challenges to implementing QbD in generic drug development.
DickinsonP.A.AbruhamssonB.S. (2008) APPS Workshop on Role of Dissolution in QbD and Drug Product Life Cycle. Co-sponsored with Food and Drug Administration. Astra Zeneca, April 2008.
2.
RathoreA.S.WinkleH. (2009) Quality by design for biopharmaceuticals. Nature Biotechnology26.
WoodcockJ. (2004) The concept of pharmaceutical quality. American Pharmaceutical Review7(6): 10–15.
5.
WoodcockJ. (2007) International Federation of Process Analytical Chemistry (IFPAC) Annual Meeting. Baltimore, MD, 28 January.
6.
LionbergR.A.LeeS.LeeL.RawA.YuL. X. (2008) Quality by design: Concepts for ANDAsThe AAPS Journal10(2): 268.
7.
Van ArnumP. (2007) A FDA Perspective on Quality by Design. New York NY: pharmatech.
8.
FDA, CDER. (2006a) Guidance for industry pharmaceutical development. May.
9.
FDA, CDER. (2006b) Guidance for quality risk management. June.
10.
FDA, CDER. (2007) Draft Guidance for industry pharmaceutical quality system. July.
11.
FDA. (2006) FDA Guidance for Industry: Quality System Approach to Pharmaceutical cGMP Regulations, US Department of Health and Human serviceRockville, MD: FDA.
12.
YuL.X. (2008) Pharmaceutical quality by design: Product and process development, understanding and controlPharmaceutical Research25(4): 784–786.
13.
US Food and Drug Administration. (2006a) Guidance for Industry: Q8 Pharmaceutical Development, US Department of Health and Human ServiceRockville, MD: FDA, May.
14.
ICH. Q8 (R1) Pharmaceutical Development Revision R1. Draft no. 8.1, http://www.ich.org, November 2007.
15.
US Food and Drug Administration. (2006b) Guidance for Industry: Q9 Quality Risk Management, US Department of Health and Human service. Rockville, MD: FDA, June.
16.
SatpathyT.K.Total quality management: A promising fixation to accomplish zero effects, http://www.pharmainfo.net.
17.
US Food and Drug Administration. (2006c) Guidance for Industry: Q10 Quality Systems Approach to Pharmaceutical cGMP Regulations. Rockville, MD: FDA, September.
18.
EMEA: European Medicine Agency — Human Medicines — EMEA Pre Submission Procedural Advice — Questions and Answers, EMEA Website, 3 July 2008.
19.
WoelbelingC. Regional Pat Cop (2008) Creating quality by design/process analytical technology (QbD/PAT) management awarenessPharmaceutical Engineering — The Official Magazine of ISPE28(3): 3.
20.
HengP.W.S.ChanL.W.TanL.H.Laser Diffraction as a Tool for Spray Drying. GEA — NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, http://PharmaManufacturing.com.
Pfizer (2006) Meeting the regulatory challenges associated with process analytical technologies. AAPS Meeting; October.
23.
ChenC.-V.MooreC. and ONDQA/CDER/FDA Role of statistics in pharmaceutical development using quality by design approach — An FDA perspective. FDA/Industry Statistics Workshops, Washington DC.
24.
Nasr, M.M. and CDER/FDA (2005) FDA Modern Regulatory System Pharmaceutical Quality Assessment. 2005Pharmaceutical Manufacturing Workshop. Dublin, Ireland, 27–30 September.
25.
NasrM.M. (2005) Establishing drug release/dissolution specifications — QbD approach. ONDQA, OPS, CDER, Advisory Committee of Pharmaceutical Science (ACPS), 25 October.
26.
NasrM.M. (2006) Implementation of Quality by Design (QbD) — Status, challenges and next steps. ONDQA, OPS, CDER, Advisory Committee of Pharmaceutical Science (ACPS), 5 October.
27.
NasrM.M. (2007) Quality by Design (QbD) — A Modern Systemic Approach to Pharmaceutical Development and Manufacturing — FDA Perspective. North Bethesdia, MD. FDA Quality Initiatives Workshop, 28 February.
