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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

Image result for IGCW-2015

GCF

presented at

4th Industrial Green Chemistry World Convention & Ecosystem (IGCW-2015) on 4th – 5th 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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 IF YOU HAVE TROUBLE VIEWING SEE…….http://www.allfordrugs.com/qbd-presentations/

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.

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

  • HA definitions
  • Why and When is a control strategy needed
  • Different types/elements of a control strategy
  • Practical examples

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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