Tout sur les médicaments הכל על תרופות كل شيئ عن الأدوية Все о наркотиках 关于药品的一切 డ్రగ్స్ గురించి అన్ని 마약에 관한 모든 것 Όλα για τα Ναρκωτικά Complete Tracking of Drugs Across the World by Dr Anthony Melvin Crasto, Worldpeacepeaker, worlddrugtracker, PH.D (ICT), MUMBAI, INDIA, Worlddrugtracker, Helping millions, 9 million hits on google on all websites, 2.5 lakh connections on all networks, “ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

QbD Presentations 1/2

Qbd by Anthony Melvin Crasto for API from Anthony Melvin Crasto Ph.D

Organizational Initiatives Towards Developing Greener Processes for Generic Active Pharmaceutical Ingredients
– Dr. Vilas H. Dahanukar, Chief Scientist-Process R&D, Integerated Product Development Organization, Dr. Reddy’s Laboratories Ltd., India

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GCF

presented at

4th Industrial Green Chemistry World Convention & Ecosystem (IGCW-2015) on 4^th– 5^th December 2015

A PRESENTATION

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A PRESENTATION

Innovative Techniques, To Synthesize Breakthrough Molecules, See DOE On pae 4 onwards

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Quality by Design Questions to Consider How can we maximize the benefits to the industry and other stakeholders? How can we ensure that this will speed.

Quality by Design (QbD) N. Vidyashankar 1Quality by Design (QbD), FICCI, 19th Jan 2012.

First to file (FTF) regulatory challenge to QbD adoption 1.

WHAT YOU NEED TO KNOW…..

Quality by Design in Drug Product Development

Introduction to drug product development – setting the scene

Drug product development at a glance – from first in man to marketing authorization
Pharmaceutical QbD: Quo vadis?
Application of QbD principles to drug product development

Expectations from regulatory agencies

Regulatory initiatives and approaches for supporting emerging technologies
Concepts of Real Time Release Testing (Draft Annex 17 EU GMP Guideline)
Harmonization of regulatory requirements (QbD parallel-assessment FDA-EMA, ICH Q8 -> Draft Q12?)
Regulatory expectations: Lessons learned from applications so far

Knowledge Management

Knowledge Management (KM) System – Definition and Reason
Knowledge Management Cycle
Explicit and Tacit Knowledge – The Knowledge Spiral
Correlation between KM and other Processes
Enabling Knowledge Management
Knowledge Review – integral part of the Management Review (ICH Q10)

Quality Risk Assessment and Control Strategy

Objectives of Quality Risk Assessment (QRA) as part of development
Overview to risk assessment tools
Introduction of Process Risk Map
Introduction of risk based control strategy development

QbD Toolbox: Case studies DoE, PAT, and Basic Statistics

Value-added use of QbD tools – generic approaches and tailored solutions
Case studies and examples for different unit operations and variable problems

Reports and Documentation

Development Reports
Transfer protocols and reports
Control Strategy and link to the submission dossier

Wrap-up & Final Discussion
The concepts and tools used over the two days will be summarized and future implications and opportunities of applying QbD principles to process development will be discussed. Delegates will be given time to ask questions on how they can apply what they have learned to their own drug product development and manufacturing.

Workshop Process Risk Map & link to Control Strategy
Based on a risk assessment tool tailored to cover development needs, delegates will work on case studies of process development for a solid oral dosage form.
From QTPP and CQA to relationship analysis of process parameters and material attributes
Process mapping for integrated documentation of the development work
Process Risk Map as a tool for development-focussed risk assessment

Quality by Design in API Manufacturing

General framework and key elements of QbD for APIs – background and potential strategies

What is it all about?
What are the benefits?
When and how should you use it?
Practical examples with typical points of discussion

How to identify and control Critical Quality Attributes (CQAs) in API synthesis – a risk-based approach to developing a control strategy

Severity assessment of quality attributes
Impact levels for critical process parameters (CPPs) and critical material attributes (CMAs)
Considerations for the API Starting material
Design of an effective risk-based control strategy
Examples

How to provide information on the development of the API manufacturing process – dossier requirements

What should be done at which stage?
Which information is relevant for the dossier?
What are the key-points to be considered for APIs (NCE/Biotech) and their formulations
Typical questions from Authorities

Process Evaluation and Design Space

Changing Validation Approach
Validation Life Cycle
Design Space Concept

Application of PAT in the API industry

PAT at development stages of a QbD-based development
PAT as part of the Control Strategy in a GMP environment
Practical examples of PAT implementations at a commercial scale in a GMP environmen

t
Control strategies – Case studies and examples