A BRIEF OVERVIEW OFPHARMACEUTICAL QUALITY BY DESIGN (QbD) : A BRIEF OVERVIEW OFPHARMACEUTICAL QUALITY BY DESIGN (QbD) PRESENTED BY,
NSHM KNOWLEDGE CAMPUS,KOLKATA GROUP OF INSTITUTION CONTENTS : CONTENTS INTRODUCTION
CURRENT APPROACH VS QbD
OVERVIEW OF QbD
REFERENCES INTRODUCTION : INTRODUCTION The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound knowledge and quality risk management. SIGNIFICANCE OF QbD : SIGNIFICANCE OF QbD • Quality by Design means
designing and developing formulations and manufacturing processes to ensure a predefined quality.
• Quality by Design requires
understanding how formulation and manufacturing process variables influence product quality.
• Quality by Design ensures
Product quality with effective control strategy, Slide 5: 5 Quality
Design Current vs. QbD Approach to Pharmaceutical Development : Current vs. QbD Approach to Pharmaceutical Development OVER VIEW OF QbD : OVER VIEW OF QbD DEFINE target product
Quality profile DESIGN formulation and
process IDENTIFY critical material
Attributes and critical process
parameters CONTROL materials and
process TARGET DESIGN IMPLEMENTATION DEFINE TARGET PRODUCT QUALITY PROFILE : DEFINE TARGET PRODUCT QUALITY PROFILE A natural extension of Target Product
Profile for product quality
– Quality characteristics (attributes) that the drug product should possess in order to reproducibly deliver the therapeutic benefit promised in the label.
Guide to establish formulation strategy and keep the formulation effort focused and efficient. Target product quality profile : Target product quality profile Dosage Form
Characteristics– Appearance, shape, size etc.
– Pharmacokinetics and bioequivalence
Target product quality profile includes CQAs of drug product
Critical quality attributes (CQAs) DESIGN FORMULATION AND PROCESS : DESIGN FORMULATION AND PROCESS Drug substance property Slide 11: Excipient Property
– Particle size, shape, solid phase, moisture content,
hygroscopicity, aqueous solubility, pKa, and density
– Chemical identity, purity, incompatibility with drug substance
Drug excipient compatibility studies
-Thermal analysis, isothermal stress etc Design drug product : Design drug product Design space : Design space Design Space– The multidimensional combination and interaction of input variables (e g. Material attributes) and process parameters that have been demonstrated to provide assurance of quality. CONTROL STRATEGIES : CONTROL STRATEGIES Control Variability : Control Variability There is uncharacterized variability in the excipients and process
Level 1 handles variability by excessively testing
Level 2 handles variability by limited testing and establishing design space for critical material attributes and process parameters
Level 3 is a robust process that can ensure quality in the presence of uncharacterized
variability. CONCLUSION : CONCLUSION Quality by Design define target product quality profile ,design and develop formulation and process to meet target product quality profile, Identify critical raw material attributes, process parameters, and sources of variability.
There is a need for vigorous and well funded research programs to develop new pharmaceutical manufacturing platforms. REFERENCES : REFERENCES  ICH Guideline Q8 – Pharmaceutical Development, http://www.ich.org (10 Nov 2005).
 U.S. Food and Drug Administration Guidance for Industry. PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, http://www.fda.gov/Cder/OPS/PAT.htm (Sep 2004).
 J.C. Berridge An Update on ICH Guideline Q8 – Pharmaceutical Development, www.fda.gov/ohrms/dockets/AC/06/ slides/2006-4241s1_2.ppt, ISPE Vienna Congress 2006.
 INTERNET Slide 18: THANK YOU