quality by design {QBD}

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A BRIEF OVERVIEW OFPHARMACEUTICAL QUALITY BY DESIGN (QbD) : 

A BRIEF OVERVIEW OFPHARMACEUTICAL QUALITY BY DESIGN (QbD) PRESENTED BY, Sandip Ghosh M.PHARM(1ST SEMESTER) NSHM KNOWLEDGE CAMPUS,KOLKATA GROUP OF INSTITUTION

CONTENTS : 

CONTENTS INTRODUCTION CURRENT APPROACH VS QbD OVERVIEW OF QbD CONCLUSION 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,

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5 Quality by 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. Identity Strength Assay Uniformity Purity/Impurity Stability, and Dissolution/Disintegration – Pharmacokinetics and bioequivalence Others Target product quality profile includes CQAs of drug product Critical quality attributes (CQAs)

DESIGN FORMULATION AND PROCESS : 

DESIGN FORMULATION AND PROCESS Drug substance property

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Excipient Property Physical property – Particle size, shape, solid phase, moisture content, hygroscopicity, aqueous solubility, pKa, and density Chemical property – Chemical identity, purity, incompatibility with drug substance Biological property Mechanical property Excipient quality 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 [1] ICH Guideline Q8 – Pharmaceutical Development, http://www.ich.org (10 Nov 2005). [2] 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). [3] 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. [4] INTERNET

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THANK YOU