SlideShare una empresa de Scribd logo

Reg & Qa GMP

•
•
L
Louise666

An introduction for people new to GMP regulatory requirements in drug development.

EmpresarialesTecnología
1 de 23
Regulatory and QA Considerations for Drug Product Development Louise Johnson, M.S. Chinese American Biopharmaceutical Society Meeting June 5, 2010
Core Principles ,[object Object],[object Object],[object Object]
Topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC Development Goals ,[object Object],[object Object],[object Object]
Standards Used to Ensure Product Quality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Principles Underlying GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Affairs Function ,[object Object],[object Object],[object Object]
Quality Assurance Function ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Control Function ,[object Object],[object Object],[object Object]
Example Company Organizational Chart CEO Quality Compliance Manufacturing Quality Assurance Quality Control Clinical & Regulatory Affairs Regulatory Affairs
So What CMC Information Is Needed At Each Stage Of Development? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC Information for Original IND ,[object Object],[object Object],[object Object],[object Object],[object Object]
IND for Phase 1 Study ,[object Object],[object Object],[object Object]
CMC Safety Concern Examples ,[object Object],[object Object],[object Object],[object Object]
IND – CMC Section ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
As Development Proceeds ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Examples of CMC Modifications That Can Affect Safety ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 2 – CMC Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 3 – CMC Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 3 – CMC Information continued ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Advice for CMC Development ,[object Object],[object Object],[object Object],[object Object]
References for NDA Preparation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Thank you!

Recomendados

GOOD MANUFACTURING PRACTICE
GOOD MANUFACTURING PRACTICEGOOD MANUFACTURING PRACTICE
GOOD MANUFACTURING PRACTICEDr. Pushkar
 
Gmp & its implementation sahil
Gmp & its implementation sahilGmp & its implementation sahil
Gmp & its implementation sahilsahilhusen
 
Good manufacturing practices
Good manufacturing practicesGood manufacturing practices
Good manufacturing practicesNoumanMomin1
 
Good manufacturing practice (GMP)
Good manufacturing practice (GMP)Good manufacturing practice (GMP)
Good manufacturing practice (GMP)Sagar Savale
 
The ten principles of gmp
The ten principles of gmpThe ten principles of gmp
The ten principles of gmpAhmed Elbaghdady
 
Good Manufacturing Practices (GMP)- Purpose and Principles
Good Manufacturing Practices (GMP)- Purpose and PrinciplesGood Manufacturing Practices (GMP)- Purpose and Principles
Good Manufacturing Practices (GMP)- Purpose and PrinciplesImran Malik
 
GMP
GMPGMP
GMPAtlantic Training, LLC.
 
GMP good manufacturing practice)
GMP good manufacturing practice) GMP good manufacturing practice)
GMP good manufacturing practice) ফজলে রাব্বি
 

Recomendados

GOOD MANUFACTURING PRACTICE
GOOD MANUFACTURING PRACTICEGOOD MANUFACTURING PRACTICE
GOOD MANUFACTURING PRACTICEDr. Pushkar
 
Gmp & its implementation sahil
Gmp & its implementation sahilGmp & its implementation sahil
Gmp & its implementation sahilsahilhusen
 
Good manufacturing practices
Good manufacturing practicesGood manufacturing practices
Good manufacturing practicesNoumanMomin1
 
Good manufacturing practice (GMP)
Good manufacturing practice (GMP)Good manufacturing practice (GMP)
Good manufacturing practice (GMP)Sagar Savale
 
The ten principles of gmp
The ten principles of gmpThe ten principles of gmp
The ten principles of gmpAhmed Elbaghdady
 
Good Manufacturing Practices (GMP)- Purpose and Principles
Good Manufacturing Practices (GMP)- Purpose and PrinciplesGood Manufacturing Practices (GMP)- Purpose and Principles
Good Manufacturing Practices (GMP)- Purpose and PrinciplesImran Malik
 
GMP
GMPGMP
GMPAtlantic Training, LLC.
 
GMP good manufacturing practice)
GMP good manufacturing practice) GMP good manufacturing practice)
GMP good manufacturing practice) ফজলে রাব্বি
 
GMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanGMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
 
Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Areej Abu Hanieh
 
Rajni ppt
Rajni pptRajni ppt
Rajni pptRajni Devi
 
GMP
GMPGMP
GMPDHUMAL KULDIP S
 
Principles of good manufacturing practice
Principles of good manufacturing practicePrinciples of good manufacturing practice
Principles of good manufacturing practiceAbd Rhman Gamil gamil
 
Good manufacturing practice (gmp)
Good manufacturing practice (gmp)Good manufacturing practice (gmp)
Good manufacturing practice (gmp)SURYAKANTVERMA2
 
10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)Arrelic
 
cGMP
cGMPcGMP
cGMPShahnazSiddiqui1
 
Training gmp slideshow
Training gmp slideshowTraining gmp slideshow
Training gmp slideshowaryandhochak
 
Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ? Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ? Tatva chintan Pharma Chem Pvt Ltd
 
Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing PracticesThulasiPadi
 
Gmp
GmpGmp
Gmpcherylkitchen
 
Concept & evolution of qa & qc
Concept & evolution of qa & qcConcept & evolution of qa & qc
Concept & evolution of qa & qcChowdaryPavani
 
Quality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsQuality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsVivek Jain
 
Cosmetic gmp induction training
Cosmetic gmp induction trainingCosmetic gmp induction training
Cosmetic gmp induction trainingMike Izon
 
Good Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic InsightsGood Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
 
C GMP
C GMPC GMP
C GMPSandip Honmane
 
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)Ashwani Dhingra
 
Master of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course DetailsMaster of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course Detailsutspharmacy
 
Lecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma IndustryLecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma IndustrySapan Shah
 
Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsQuality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
 
IND Application Process and Best Practices
IND Application Process and Best PracticesIND Application Process and Best Practices
IND Application Process and Best PracticesCFTCC
 

Más contenido relacionado

La actualidad más candente

GMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanGMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
 
Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Areej Abu Hanieh
 
Principles of good manufacturing practice
Principles of good manufacturing practicePrinciples of good manufacturing practice
Principles of good manufacturing practiceAbd Rhman Gamil gamil
 
Good manufacturing practice (gmp)
Good manufacturing practice (gmp)Good manufacturing practice (gmp)
Good manufacturing practice (gmp)SURYAKANTVERMA2
 
10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)Arrelic
 
Training gmp slideshow
Training gmp slideshowTraining gmp slideshow
Training gmp slideshowaryandhochak
 
Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ? Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ? Tatva chintan Pharma Chem Pvt Ltd
 
Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing PracticesThulasiPadi
 
Concept & evolution of qa & qc
Concept & evolution of qa & qcConcept & evolution of qa & qc
Concept & evolution of qa & qcChowdaryPavani
 
Quality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsQuality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsVivek Jain
 
Cosmetic gmp induction training
Cosmetic gmp induction trainingCosmetic gmp induction training
Cosmetic gmp induction trainingMike Izon
 
Good Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic InsightsGood Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
 
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)Ashwani Dhingra
 
Master of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course DetailsMaster of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course Detailsutspharmacy
 
Lecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma IndustryLecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma IndustrySapan Shah
 

La actualidad más candente (20)

GMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanGMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S Charan
 
Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding
 
Rajni ppt
Rajni pptRajni ppt
Rajni ppt
 
GMP
GMPGMP
GMP
 
Principles of good manufacturing practice
Principles of good manufacturing practicePrinciples of good manufacturing practice
Principles of good manufacturing practice
 
Good manufacturing practice (gmp)
Good manufacturing practice (gmp)Good manufacturing practice (gmp)
Good manufacturing practice (gmp)
 
10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)10 Principles of Good Manufacturing Practice (GMP)
10 Principles of Good Manufacturing Practice (GMP)
 
cGMP
cGMPcGMP
cGMP
 
Training gmp slideshow
Training gmp slideshowTraining gmp slideshow
Training gmp slideshow
 
Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ? Why good manufacturing practice is a must in chemical industry ?
Why good manufacturing practice is a must in chemical industry ?
 
Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing Practices
 
Gmp
GmpGmp
Gmp
 
Concept & evolution of qa & qc
Concept & evolution of qa & qcConcept & evolution of qa & qc
Concept & evolution of qa & qc
 
Quality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsQuality Assurance and Quality Management Concepts
Quality Assurance and Quality Management Concepts
 
Cosmetic gmp induction training
Cosmetic gmp induction trainingCosmetic gmp induction training
Cosmetic gmp induction training
 
Good Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic InsightsGood Manufacturing Practice (GMP) | Arrelic Insights
Good Manufacturing Practice (GMP) | Arrelic Insights
 
C GMP
C GMPC GMP
C GMP
 
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP)
 
Master of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course DetailsMaster of Good Manufacturing Practice - Course Details
Master of Good Manufacturing Practice - Course Details
 
Lecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma IndustryLecture 2: QA and Qc in Pharma Industry
Lecture 2: QA and Qc in Pharma Industry
 

Destacado

Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsQuality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
 
IND Application Process and Best Practices
IND Application Process and Best PracticesIND Application Process and Best Practices
IND Application Process and Best PracticesCFTCC
 
Quality Management Systems Potential LLC Brochure
Quality Management Systems Potential LLC BrochureQuality Management Systems Potential LLC Brochure
Quality Management Systems Potential LLC BrochureSteve Gompertz
 
INDs: When Required and Contents
INDs: When Required and ContentsINDs: When Required and Contents
INDs: When Required and ContentsLouise666
 
Quality management systems for medical, pharmaceutical,
Quality management systems for medical, pharmaceutical,Quality management systems for medical, pharmaceutical,
Quality management systems for medical, pharmaceutical,Khalizan Halid
 
Quality Management System of Coca-Cola
Quality Management System of Coca-ColaQuality Management System of Coca-Cola
Quality Management System of Coca-ColaTharushika Ruwangi
 
Quality Management Systems in different industries - from ISO 9001 to cGxP
Quality Management Systems in different industries - from ISO 9001 to cGxPQuality Management Systems in different industries - from ISO 9001 to cGxP
Quality Management Systems in different industries - from ISO 9001 to cGxPPauwels Consulting
 
Total quality management 1 .pps
Total quality management 1 .ppsTotal quality management 1 .pps
Total quality management 1 .ppsharshavardhanan
 
Total quality management (tqm)ادارة الجودة الشاملة
Total quality management (tqm)ادارة الجودة الشاملةTotal quality management (tqm)ادارة الجودة الشاملة
Total quality management (tqm)ادارة الجودة الشاملةIbrahim Alhariri
 

Destacado (12)

Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsQuality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticals
 
IND Application Process and Best Practices
IND Application Process and Best PracticesIND Application Process and Best Practices
IND Application Process and Best Practices
 
Quality Management Systems
Quality Management SystemsQuality Management Systems
Quality Management Systems
 
Supplier Selection
Supplier SelectionSupplier Selection
Supplier Selection
 
Quality Management Systems Potential LLC Brochure
Quality Management Systems Potential LLC BrochureQuality Management Systems Potential LLC Brochure
Quality Management Systems Potential LLC Brochure
 
INDs: When Required and Contents
INDs: When Required and ContentsINDs: When Required and Contents
INDs: When Required and Contents
 
Quality management systems for medical, pharmaceutical,
Quality management systems for medical, pharmaceutical,Quality management systems for medical, pharmaceutical,
Quality management systems for medical, pharmaceutical,
 
Quality Management System of Coca-Cola
Quality Management System of Coca-ColaQuality Management System of Coca-Cola
Quality Management System of Coca-Cola
 
Quality Management Systems in different industries - from ISO 9001 to cGxP
Quality Management Systems in different industries - from ISO 9001 to cGxPQuality Management Systems in different industries - from ISO 9001 to cGxP
Quality Management Systems in different industries - from ISO 9001 to cGxP
 
Total quality management 1 .pps
Total quality management 1 .ppsTotal quality management 1 .pps
Total quality management 1 .pps
 
QUALITY ASSURANCE
QUALITY ASSURANCEQUALITY ASSURANCE
QUALITY ASSURANCE
 
Total quality management (tqm)ادارة الجودة الشاملة
Total quality management (tqm)ادارة الجودة الشاملةTotal quality management (tqm)ادارة الجودة الشاملة
Total quality management (tqm)ادارة الجودة الشاملة
 

Similar a Reg & Qa GMP

CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcCMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcJayeshRajput7
 
CMC , POST APPROVAL CHANGES.pptx
CMC , POST APPROVAL CHANGES.pptxCMC , POST APPROVAL CHANGES.pptx
CMC , POST APPROVAL CHANGES.pptxSakshiSonawane6
 
Cmc and post regulatory
Cmc and post regulatoryCmc and post regulatory
Cmc and post regulatoryDev Jain
 
Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation IshwarJadhav4
 
Biotech2007[1]
Biotech2007[1]Biotech2007[1]
Biotech2007[1]kamyabi
 
Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp 112070804010Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp 112070804010Patel Parth
 
Essentials in qb_d
Essentials in qb_dEssentials in qb_d
Essentials in qb_dPRASAD PSR
 
KEYTRUDA® Biosimilar CMC Analytical Solutions
KEYTRUDA® Biosimilar CMC Analytical SolutionsKEYTRUDA® Biosimilar CMC Analytical Solutions
KEYTRUDA® Biosimilar CMC Analytical SolutionsCovance
 
Regulatory Compliance in Pharmaceutical DevelopmentGL.docx
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxRegulatory Compliance in Pharmaceutical DevelopmentGL.docx
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxsodhi3
 
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...Mahesh B. Wazade
 
Regulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairsRegulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairsArjunDhawale
 
FDA inspection of manufacturing sites
FDA inspection of manufacturing sitesFDA inspection of manufacturing sites
FDA inspection of manufacturing sitesSagar Nemade
 
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61
 
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...Bachu Sreekanth
 
OPDIVO® Biosimilar CMC Analytical Solutions
OPDIVO® Biosimilar CMC Analytical SolutionsOPDIVO® Biosimilar CMC Analytical Solutions
OPDIVO® Biosimilar CMC Analytical SolutionsCovance
 
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdf
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdfOral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdf
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdfJenniferGuerrero53
 
An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An Efficient Analytical Development Strategy for Rapid Development of Biophar...An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An Efficient Analytical Development Strategy for Rapid Development of Biophar...ManivannanKathirvel1
 

Similar a Reg & Qa GMP (20)

CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcCMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etc
 
CMC , POST APPROVAL CHANGES.pptx
CMC , POST APPROVAL CHANGES.pptxCMC , POST APPROVAL CHANGES.pptx
CMC , POST APPROVAL CHANGES.pptx
 
Cmc and post regulatory
Cmc and post regulatoryCmc and post regulatory
Cmc and post regulatory
 
C gmp0
C gmp0C gmp0
C gmp0
 
Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation
 
Biotech2007[1]
Biotech2007[1]Biotech2007[1]
Biotech2007[1]
 
Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp 112070804010Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp 112070804010
 
Essentials in qb_d
Essentials in qb_dEssentials in qb_d
Essentials in qb_d
 
KEYTRUDA® Biosimilar CMC Analytical Solutions
KEYTRUDA® Biosimilar CMC Analytical SolutionsKEYTRUDA® Biosimilar CMC Analytical Solutions
KEYTRUDA® Biosimilar CMC Analytical Solutions
 
Regulatory Compliance in Pharmaceutical DevelopmentGL.docx
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxRegulatory Compliance in Pharmaceutical DevelopmentGL.docx
Regulatory Compliance in Pharmaceutical DevelopmentGL.docx
 
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...
AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLE...
 
Regulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairsRegulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairs
 
FDA inspection of manufacturing sites
FDA inspection of manufacturing sitesFDA inspection of manufacturing sites
FDA inspection of manufacturing sites
 
CMCIssues
CMCIssuesCMCIssues
CMCIssues
 
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )
 
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
 
ICH Q11 Slide Summary
ICH Q11 Slide SummaryICH Q11 Slide Summary
ICH Q11 Slide Summary
 
OPDIVO® Biosimilar CMC Analytical Solutions
OPDIVO® Biosimilar CMC Analytical SolutionsOPDIVO® Biosimilar CMC Analytical Solutions
OPDIVO® Biosimilar CMC Analytical Solutions
 
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdf
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdfOral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdf
Oral Solid Dosage Forms Pre_Post Approval Issues (1_94) _ FDA.pdf
 
An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An Efficient Analytical Development Strategy for Rapid Development of Biophar...An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An Efficient Analytical Development Strategy for Rapid Development of Biophar...
 

Último

Uneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration PresentationUneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration Presentationuneakwhite
 
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...ssuserf63bd7
 
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...meghakumariji156
 
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in PakistanChallenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistanvineshkumarsajnani12
 
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai KuwaitThe Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwaitdaisycvs
 
Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024Marel
 
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 Months
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 MonthsSEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 Months
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 MonthsIndeedSEO
 
Kalyan Call Girl 98350*37198 Call Girls in Escort service book now
Kalyan Call Girl 98350*37198 Call Girls in Escort service book nowKalyan Call Girl 98350*37198 Call Girls in Escort service book now
Kalyan Call Girl 98350*37198 Call Girls in Escort service book nowranineha57744
 
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service AvailableBerhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Availablepr788182
 
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book nowPARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book nowkapoorjyoti4444
 
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAIGetting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAITim Wilson
 
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfArti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfwill854175
 
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSCROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSpanmisemningshen123
 
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptxPutting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptxCynthia Clay
 
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTSDurg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTSkajalroy875762
 
New 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck TemplateNew 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck TemplateCannaBusinessPlans
 
Organizational Transformation Lead with Culture
Organizational Transformation Lead with CultureOrganizational Transformation Lead with Culture
Organizational Transformation Lead with CultureSeta Wicaksana
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPanhandleOilandGas
 

Último (20)

HomeRoots Pitch Deck | Investor Insights | April 2024
HomeRoots Pitch Deck | Investor Insights | April 2024HomeRoots Pitch Deck | Investor Insights | April 2024
HomeRoots Pitch Deck | Investor Insights | April 2024
 
Uneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration PresentationUneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration Presentation
 
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...
Horngren’s Cost Accounting A Managerial Emphasis, Canadian 9th edition soluti...
 
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...
Escorts in Nungambakkam Phone 8250092165 Enjoy 24/7 Escort Service Enjoy Your...
 
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in PakistanChallenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
 
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai KuwaitThe Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
 
Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024
 
Buy gmail accounts.pdf buy Old Gmail Accounts
Buy gmail accounts.pdf buy Old Gmail AccountsBuy gmail accounts.pdf buy Old Gmail Accounts
Buy gmail accounts.pdf buy Old Gmail Accounts
 
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 Months
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 MonthsSEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 Months
SEO Case Study: How I Increased SEO Traffic & Ranking by 50-60% in 6 Months
 
Kalyan Call Girl 98350*37198 Call Girls in Escort service book now
Kalyan Call Girl 98350*37198 Call Girls in Escort service book nowKalyan Call Girl 98350*37198 Call Girls in Escort service book now
Kalyan Call Girl 98350*37198 Call Girls in Escort service book now
 
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service AvailableBerhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
 
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book nowPARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
 
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAIGetting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
 
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfArti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdf
 
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSCROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
 
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptxPutting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptx
 
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTSDurg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
 
New 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck TemplateNew 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck Template
 
Organizational Transformation Lead with Culture
Organizational Transformation Lead with CultureOrganizational Transformation Lead with Culture
Organizational Transformation Lead with Culture
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation Final
 

Reg & Qa GMP

  • 1. Regulatory and QA Considerations for Drug Product Development Louise Johnson, M.S. Chinese American Biopharmaceutical Society Meeting June 5, 2010
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. Example Company Organizational Chart CEO Quality Compliance Manufacturing Quality Assurance Quality Control Clinical & Regulatory Affairs Regulatory Affairs
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.