Presentation ICH Q8 annex QbD- november 2008

•Transferir como PPT, PDF•

19 gostaram•3,643 visualizações

Mohamad Haitham Ayad

Pharmaceutical Development: ICH Q8 - QbD

Saúde e medicina Negócios Tecnologia

[object Object],[object Object],[object Object],ICH Q8 Annex

REGULATORY STATUS : STEP 3 ? DATE FOR COMING INTO OPERATION ? FINAL APPROVAL BY CHMP May 2008 DEADLINE FOR COMMENTS November 2007 TRANSMISSION TO INTERESTED PARTIES November 2007 TRANSMISSION TO CHMP

[object Object],[object Object],[object Object]

THE WALL STREET JOURNAL Septembre 3, 2003 ,[object Object]

APPROACHES TO PHARMACEUTICAL DEVELOPMENT (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

APPROACHES TO PHARMACEUTICAL DEVELOPMENT (2) ,[object Object],[object Object]

APPROACHES TO PHARMACEUTICAL DEVELOPMENT (3) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

ADVANTEGES OF QUALITY BY DESIGN APPROACH ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (1) ,[object Object],[object Object],[object Object],[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (2) ,[object Object],[object Object],[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (3) ,[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (4) Manufacturing Implementation Process Scale-up & Tech Transfer Process Development Formulation Development Role of Quality Risk Management Risk Management Product quality control strategy Risk Control Risk Assessment Process design space Process Understanding Excipient & drug substance design space Product/prior Knowledge Risk Assessment Continual improvement Process History Risk Review

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (5) ,[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (6)

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (7) Response surface plot of dissolution as a function of two parameters of a granulation operation. Dissolution above 80% is desired. Example Of Presentation Of Design Space

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (8) ,[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (9) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (10) ,[object Object],[object Object],[object Object]

Mais conteúdo relacionado

Mais procurados

Ich q8Swastik Jyoti

Quality by-Design (QbD) by Mr. Nitin Kadam.Nitin Kadam

Product Stability Studies & Stability Testing Amit Attri

NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420

Process validation of Tablets and LquidsRaheem Kurikkal

QMS stability testing.pptxThoratPrajaktaSanjay

ICH Q8 GuidelinesMANIKANDAN V

Documentation in Pharmaceutical IndustryNavaneethakrishnan Palaniappan

Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1

OOS.pptxNeeraj Kumar Rai

ctd and e ctd submissionRohit K.

Q6 guidelinesAnjali Aji

Stability study as per ich guideline RaKesh Rathava

Quality by Design and Process Analytical Technologychandnichandarana1

ANDA Stability RequirementsGMP EDUCATION : Not for Profit Organization

ICH Guidelines for stability testingAnkitaKawtikwar

Regulatory requirements for api registrationRiyaRYadav

Process Validation of Liquid OralsAasawaree Yadav

Validation of tablet processPradnya Shirude

Quality target product profile (QTPP)Priyesh singh

Mais procurados (20)

Ich q8

Quality by-Design (QbD) by Mr. Nitin Kadam.

Product Stability Studies & Stability Testing

NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGES

Process validation of Tablets and Lquids

QMS stability testing.pptx

ICH Q8 Guidelines

Documentation in Pharmaceutical Industry

Technology Transfer and Scale-up in Pharmaceutical Industry

OOS.pptx

ctd and e ctd submission

Q6 guidelines

Stability study as per ich guideline

Quality by Design and Process Analytical Technology

ANDA Stability Requirements

ICH Guidelines for stability testing

Regulatory requirements for api registration

Process Validation of Liquid Orals

Validation of tablet process

Quality target product profile (QTPP)

Destaque

ICH Q8 (Pharmaceutical Development)PHARMADVISOR

Biotech ProductsHamidul Kowsar

Q10 general presentationVMG CONSULTORIA E ASSESSORIA EM VIGILANCIA SANITARIA

ICH Q8 Parte 1Fernando Tazón Alvarez

ICH Q 10 guidline umeshlove4u

Ich – quality guidelinesHarishankar Sahu

Quality by Design : Design SpaceGMP EDUCATION : Not for Profit Organization

Concept of MIcelle & CMCAkshay Pawar

Bioavailability and Bioequivalence Studies (BABE) & Concept of BiowaiversJaspreet Guraya

Stability studies ICH Q1A-Q1E Guidelines pptAman K Dhamrait

Pharma Industry OverviewSudeep DSouza

ICH Guideline Q9 - Quality Risk Managementmuna_ali

Destaque (12)

ICH Q8 (Pharmaceutical Development)

Biotech Products

Q10 general presentation

ICH Q8 Parte 1

ICH Q 10 guidline

Ich – quality guidelines

Quality by Design : Design Space

Concept of MIcelle & CMC

Bioavailability and Bioequivalence Studies (BABE) & Concept of Biowaivers

Stability studies ICH Q1A-Q1E Guidelines ppt

Pharma Industry Overview

ICH Guideline Q9 - Quality Risk Management

Semelhante a Presentation ICH Q8 annex QbD- november 2008

Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61

QbD.pptxAJETHGJ

Qbdjatin singla

Pharmaceutical Quality by Design (QbD)ChinmayGramopadhye

Seminar on QbD By Dipu.pptxGNIPST

Quality by design in pharmaceutical developmentSHUBHAMGWAGH

Quality by designsonalsuryawanshi2

Quality by designBALASUNDARESAN M

Quality by Design.pptxBhuminJain1

Qb D Akhilesh Dwivedipharmaakd

quality by designAMOGH DANDEKAR

Quality by Designmahesh745

ICH Q-8 Quality by DesignShubham Bhujbal

Essentials in qb_dPRASAD PSR

Quality by designsuhasini

Quality by design Farjana Rahman

Quality by design.. ppt for RA (1ST SEMCharmi13

D3. Pharmaceutical Development, Quality by Design.pptxGebremariamWondie

Quality by design JyotsnaMalunjkar

ICH Q11 Slide SummaryDilawarHussain34

Semelhante a Presentation ICH Q8 annex QbD- november 2008 (20)

Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )

QbD.pptx

Qbd

Pharmaceutical Quality by Design (QbD)

Seminar on QbD By Dipu.pptx

Quality by design in pharmaceutical development

Quality by design

Quality by Design.pptx

Qb D Akhilesh Dwivedi

quality by design

Quality by Design

ICH Q-8 Quality by Design

Essentials in qb_d

Quality by design

Quality by design.. ppt for RA (1ST SEM

D3. Pharmaceutical Development, Quality by Design.pptx

Quality by design

ICH Q11 Slide Summary

Último

Top Rated Hyderabad Call Girls Erragadda ⟟ 6297143586 ⟟ Call Me For Genuine ...chandars293

Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiAlinaDevecerski

Call Girls Bhubaneswar Just Call 9907093804 Top Class Call Girl Service Avail...Dipal Arora

♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...astropune

Call Girls Ludhiana Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora

Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...astropune

Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Servicevidya singh

Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora

Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...narwatsonia7

(Rocky) Jaipur Call Girl - 09521753030 Escorts Service 50% Off with Cash ON D...indiancallgirl4rent

Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora

The Most Attractive Hyderabad Call Girls Kothapet 𖠋 6297143586 𖠋 Will You Mis...chandars293

Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...Dipal Arora

VIP Call Girls Indore Kirti 💚😋 9256729539 🚀 Indore Escortsaditipandeya

(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...parulsinha

Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora

VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...jageshsingh5554

Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escortsvidya singh

Call Girls Faridabad Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora

Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...narwatsonia7

Presentation ICH Q8 annex QbD- november 2008

2. REGULATORY STATUS : STEP 3 ? DATE FOR COMING INTO OPERATION ? FINAL APPROVAL BY CHMP May 2008 DEADLINE FOR COMMENTS November 2007 TRANSMISSION TO INTERESTED PARTIES November 2007 TRANSMISSION TO CHMP

10.

11.

12. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (4) Manufacturing Implementation Process Scale-up & Tech Transfer Process Development Formulation Development Role of Quality Risk Management Risk Management Product quality control strategy Risk Control Risk Assessment Process design space Process Understanding Excipient & drug substance design space Product/prior Knowledge Risk Assessment Continual improvement Process History Risk Review

13.

14. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (6)

15. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (7) Response surface plot of dissolution as a function of two parameters of a granulation operation. Dissolution above 80% is desired. Example Of Presentation Of Design Space

16. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (7) Response surface plot of dissolution as a function of two parameters of a granulation operation. Dissolution above 80% is desired. Example Of Presentation Of Design Space

17.

18.

19.

Presentation ICH Q8 annex QbD- november 2008

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (20)

Destaque

Destaque (12)

Semelhante a Presentation ICH Q8 annex QbD- november 2008

Semelhante a Presentation ICH Q8 annex QbD- november 2008 (20)

Último

Último (20)

Presentation ICH Q8 annex QbD- november 2008