SlideShare a Scribd company logo
1 of 42
GMP AND cGMP CONSIDERATIONS Dr. Basavaraj K. Nanjwade  M.Pharm., Ph.D. Associate Professor Department of Pharmaceutics KLE University BELGAUM - 590010 By
What is GMP ? ,[object Object],[object Object]
What is cGMP ? ,[object Object]
Quality Definition ,[object Object],[object Object],[object Object],[object Object]
 
Good Manufacturing Practices ,[object Object],[object Object]
Some of the main risks are ,[object Object],[object Object],[object Object]
Why GMP is important ,[object Object],[object Object]
GMP helps boost pharmaceutical export opportunities ,[object Object],[object Object]
GMP Covers… ,[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object]
QA, GMP & QC inter-relationship QC GMP QA
QA, GMP & QC inter-relationship ,[object Object],QA
QA, GMP & QC inter-relationship ,[object Object],GMP
QA, GMP & QC inter-relationship ,[object Object],QC
QC and QA ,[object Object],[object Object],[object Object]
QC and QA ,[object Object],[object Object]
QC and QA ,[object Object],[object Object]
GMP guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object]
Ten Principles of GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Beyond GMP ,[object Object],[object Object],[object Object],[object Object],[object Object]
Cost of effective GMP ,[object Object],[object Object],[object Object],[object Object]
List of important documents  in GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
10 attributes of a good document ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Certifying agencies ,[object Object],[object Object],[object Object],[object Object]
How do GMPs of different countries compare? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP For Finished Pharmaceuticals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Provision ,[object Object],[object Object]
Organization & Personnel ,[object Object],[object Object],[object Object],[object Object]
Building & Facilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Equipment ,[object Object],[object Object],[object Object],[object Object],[object Object]
Control of Components & Drug Product Containers & Closures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Production & Process Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Packaging & Labeling Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling & Distribution ,[object Object],[object Object]
Laboratory Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Records & Reports ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Returned & Salvaged Drug Products ,[object Object],[object Object]
[object Object],E-mail:  [email_address] Cell No: 9448716277

More Related Content

What's hot

PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATIONSACHIN C P
 
cGMP Guidelines according to USFDA
cGMP Guidelines according to USFDAcGMP Guidelines according to USFDA
cGMP Guidelines according to USFDAMANIKANDAN V
 
Analytical method validation
Analytical method validationAnalytical method validation
Analytical method validationSUBHASISH DAS
 
IPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryIPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryKay kay shain marma
 
INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)Chetan Pawar 2829
 
Introduction to quality assurance and qualtiy control
Introduction to quality assurance and qualtiy controlIntroduction to quality assurance and qualtiy control
Introduction to quality assurance and qualtiy controlAmruta Balekundri
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical
 
Pharmaceutical validation & it's types
 Pharmaceutical validation & it's types Pharmaceutical validation & it's types
Pharmaceutical validation & it's typesAlexa Jacob
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study pptpharmacy
 
GMP and cGMP
GMP and cGMPGMP and cGMP
GMP and cGMPGaurav Kr
 
Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)GOKULAKRISHNAN S
 
Ipqc tests for tablet
Ipqc tests for tabletIpqc tests for tablet
Ipqc tests for tabletMalay Jivani
 
Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp  112070804010Concept of qa, qc, gmp  112070804010
Concept of qa, qc, gmp 112070804010Patel Parth
 

What's hot (20)

Master formula record
Master formula recordMaster formula record
Master formula record
 
PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATION
 
cGMP Guidelines according to USFDA
cGMP Guidelines according to USFDAcGMP Guidelines according to USFDA
cGMP Guidelines according to USFDA
 
ICH QSEM Guidelines
ICH QSEM GuidelinesICH QSEM Guidelines
ICH QSEM Guidelines
 
Analytical method validation
Analytical method validationAnalytical method validation
Analytical method validation
 
IPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryIPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industry
 
INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)
 
Introduction to quality assurance and qualtiy control
Introduction to quality assurance and qualtiy controlIntroduction to quality assurance and qualtiy control
Introduction to quality assurance and qualtiy control
 
ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & Validation
 
Out of specification (oos)1
Out of specification (oos)1Out of specification (oos)1
Out of specification (oos)1
 
Pharmaceutical validation & it's types
 Pharmaceutical validation & it's types Pharmaceutical validation & it's types
Pharmaceutical validation & it's types
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study ppt
 
USFDA
USFDAUSFDA
USFDA
 
GMP and cGMP
GMP and cGMPGMP and cGMP
GMP and cGMP
 
Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)
 
BMR & MFR
BMR & MFRBMR & MFR
BMR & MFR
 
Ipqc tests for tablet
Ipqc tests for tabletIpqc tests for tablet
Ipqc tests for tablet
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Concept of qa, qc, gmp 112070804010
Concept of qa, qc, gmp  112070804010Concept of qa, qc, gmp  112070804010
Concept of qa, qc, gmp 112070804010
 

Viewers also liked

Pyrogen testing
Pyrogen testingPyrogen testing
Pyrogen testingnilesh1208
 
Pharmaceutical reagents, PDAB, FC, MBTH
Pharmaceutical reagents, PDAB, FC, MBTHPharmaceutical reagents, PDAB, FC, MBTH
Pharmaceutical reagents, PDAB, FC, MBTHDivya Naidu
 
c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)Rohit K.
 
current good manufacturing practices as per who
current good manufacturing practices as per whocurrent good manufacturing practices as per who
current good manufacturing practices as per whoDilipkumar Velde
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practiceDr Subodh Satheesh
 
Reaction intermediates
Reaction intermediatesReaction intermediates
Reaction intermediatesneha jain
 
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
 

Viewers also liked (9)

Reaction intermediates
Reaction intermediatesReaction intermediates
Reaction intermediates
 
Pyrogen testing
Pyrogen testingPyrogen testing
Pyrogen testing
 
Pharmaceutical reagents, PDAB, FC, MBTH
Pharmaceutical reagents, PDAB, FC, MBTHPharmaceutical reagents, PDAB, FC, MBTH
Pharmaceutical reagents, PDAB, FC, MBTH
 
c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)
 
current good manufacturing practices as per who
current good manufacturing practices as per whocurrent good manufacturing practices as per who
current good manufacturing practices as per who
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practice
 
cGMP.
cGMP.cGMP.
cGMP.
 
Reaction intermediates
Reaction intermediatesReaction intermediates
Reaction intermediates
 
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
 

Similar to GMP AND cGMP CONSIDERATIONS

Gmp & its implementation sahil
Gmp & its implementation sahilGmp & its implementation sahil
Gmp & its implementation sahilsahilhusen
 
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 CGMP .pdf
GMP CGMP .pdfGMP CGMP .pdf
GMP CGMP .pdfUVAS
 
GMP (GOOD MANUFACTURING PRACTICES)
GMP (GOOD MANUFACTURING PRACTICES)GMP (GOOD MANUFACTURING PRACTICES)
GMP (GOOD MANUFACTURING PRACTICES)Nidhi Sharma
 
Pharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical
 
2) Total Quality Managment
2) Total Quality Managment2) Total Quality Managment
2) Total Quality ManagmentSangam Kanthale
 
Basic concepts of QA and QC
Basic concepts of QA and QCBasic concepts of QA and QC
Basic concepts of QA and QCGargi Nanda
 
Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation IshwarJadhav4
 
Gmp c gmp presentation
Gmp c gmp presentationGmp c gmp presentation
Gmp c gmp presentationDeepak Amoli
 
An overview of_quality_assurance_departm (2)
An overview of_quality_assurance_departm (2)An overview of_quality_assurance_departm (2)
An overview of_quality_assurance_departm (2)Pranvera Apostoli
 
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 ASSURANCE AND QUALITY.pptx
QUALITY ASSURANCE AND QUALITY.pptxQUALITY ASSURANCE AND QUALITY.pptx
QUALITY ASSURANCE AND QUALITY.pptxarpitajena10
 
GMP and cGMP consideration
GMP and cGMP considerationGMP and cGMP consideration
GMP and cGMP considerationRavish Yadav
 
2-Quality-assurance-6th-Sem Quality control and GMP
2-Quality-assurance-6th-Sem Quality control and GMP2-Quality-assurance-6th-Sem Quality control and GMP
2-Quality-assurance-6th-Sem Quality control and GMPVenkatesh Mantha
 
Introduction qa, qc and tqm
Introduction qa, qc and tqmIntroduction qa, qc and tqm
Introduction qa, qc and tqmhimanshu kamboj
 

Similar to GMP AND cGMP CONSIDERATIONS (20)

Gmp & its implementation sahil
Gmp & its implementation sahilGmp & its implementation sahil
Gmp & its implementation sahil
 
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 Principles
 
GMP CGMP .pdf
GMP CGMP .pdfGMP CGMP .pdf
GMP CGMP .pdf
 
GMP (GOOD MANUFACTURING PRACTICES)
GMP (GOOD MANUFACTURING PRACTICES)GMP (GOOD MANUFACTURING PRACTICES)
GMP (GOOD MANUFACTURING PRACTICES)
 
Pharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing Practices
 
Quality
QualityQuality
Quality
 
2) Total Quality Managment
2) Total Quality Managment2) Total Quality Managment
2) Total Quality Managment
 
Basic concepts of QA and QC
Basic concepts of QA and QCBasic concepts of QA and QC
Basic concepts of QA and QC
 
cGMP.pptx
cGMP.pptxcGMP.pptx
cGMP.pptx
 
C GMP
C GMPC GMP
C GMP
 
Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation
 
Gmp c gmp presentation
Gmp c gmp presentationGmp c gmp presentation
Gmp c gmp presentation
 
An overview of_quality_assurance_departm (2)
An overview of_quality_assurance_departm (2)An overview of_quality_assurance_departm (2)
An overview of_quality_assurance_departm (2)
 
QCQA
QCQAQCQA
QCQA
 
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
 
QUALITY ASSURANCE AND QUALITY.pptx
QUALITY ASSURANCE AND QUALITY.pptxQUALITY ASSURANCE AND QUALITY.pptx
QUALITY ASSURANCE AND QUALITY.pptx
 
Quality assurance basics
Quality assurance basicsQuality assurance basics
Quality assurance basics
 
GMP and cGMP consideration
GMP and cGMP considerationGMP and cGMP consideration
GMP and cGMP consideration
 
2-Quality-assurance-6th-Sem Quality control and GMP
2-Quality-assurance-6th-Sem Quality control and GMP2-Quality-assurance-6th-Sem Quality control and GMP
2-Quality-assurance-6th-Sem Quality control and GMP
 
Introduction qa, qc and tqm
Introduction qa, qc and tqmIntroduction qa, qc and tqm
Introduction qa, qc and tqm
 

More from Prof. Dr. Basavaraj Nanjwade

Good laboratory practices for pharmaceuticals and biopharmaceuticals
Good laboratory practices for pharmaceuticals  and  biopharmaceuticalsGood laboratory practices for pharmaceuticals  and  biopharmaceuticals
Good laboratory practices for pharmaceuticals and biopharmaceuticalsProf. Dr. Basavaraj Nanjwade
 
Packaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsPackaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsProf. Dr. Basavaraj Nanjwade
 
QbD for Product Development of Solid Semisolid and Liquid Dosage Forms
QbD for Product Development of Solid Semisolid and Liquid Dosage FormsQbD for Product Development of Solid Semisolid and Liquid Dosage Forms
QbD for Product Development of Solid Semisolid and Liquid Dosage FormsProf. Dr. Basavaraj Nanjwade
 
Development, safety and stability of biotechnological and biological products
Development, safety and stability of biotechnological and biological productsDevelopment, safety and stability of biotechnological and biological products
Development, safety and stability of biotechnological and biological productsProf. Dr. Basavaraj Nanjwade
 
Clinical studies and trials on traditional medicine and natural products
Clinical studies and trials on traditional medicine and natural productsClinical studies and trials on traditional medicine and natural products
Clinical studies and trials on traditional medicine and natural productsProf. Dr. Basavaraj Nanjwade
 

More from Prof. Dr. Basavaraj Nanjwade (20)

COVID-19 and Novel Drug Delivery System.ppt
COVID-19 and Novel Drug Delivery System.pptCOVID-19 and Novel Drug Delivery System.ppt
COVID-19 and Novel Drug Delivery System.ppt
 
Good laboratory practices for pharmaceuticals and biopharmaceuticals
Good laboratory practices for pharmaceuticals  and  biopharmaceuticalsGood laboratory practices for pharmaceuticals  and  biopharmaceuticals
Good laboratory practices for pharmaceuticals and biopharmaceuticals
 
Opportunities and future for pharmacist
Opportunities and future for pharmacistOpportunities and future for pharmacist
Opportunities and future for pharmacist
 
Opportunities and future for pharmacist
Opportunities and future for pharmacistOpportunities and future for pharmacist
Opportunities and future for pharmacist
 
Novel drug delivery system
Novel drug delivery systemNovel drug delivery system
Novel drug delivery system
 
Packaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsPackaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for Pharmaceuticals
 
QbD for Product Development of Solid Semisolid and Liquid Dosage Forms
QbD for Product Development of Solid Semisolid and Liquid Dosage FormsQbD for Product Development of Solid Semisolid and Liquid Dosage Forms
QbD for Product Development of Solid Semisolid and Liquid Dosage Forms
 
Opportunities and Future for Pharma Buddies
Opportunities and Future for Pharma BuddiesOpportunities and Future for Pharma Buddies
Opportunities and Future for Pharma Buddies
 
Development of Clinical Formulation
Development of Clinical FormulationDevelopment of Clinical Formulation
Development of Clinical Formulation
 
QbD for Pharma Products Development
QbD for Pharma Products DevelopmentQbD for Pharma Products Development
QbD for Pharma Products Development
 
Development, safety and stability of biotechnological and biological products
Development, safety and stability of biotechnological and biological productsDevelopment, safety and stability of biotechnological and biological products
Development, safety and stability of biotechnological and biological products
 
Clinical studies and trials on traditional medicine and natural products
Clinical studies and trials on traditional medicine and natural productsClinical studies and trials on traditional medicine and natural products
Clinical studies and trials on traditional medicine and natural products
 
Clinical drug design
Clinical drug designClinical drug design
Clinical drug design
 
Clinical drug development
Clinical drug developmentClinical drug development
Clinical drug development
 
Clinical drug design
Clinical drug designClinical drug design
Clinical drug design
 
Solid dosage forms (tablets)
Solid dosage forms (tablets)Solid dosage forms (tablets)
Solid dosage forms (tablets)
 
Solid dosage forms (capsules)
Solid dosage forms (capsules)Solid dosage forms (capsules)
Solid dosage forms (capsules)
 
Preparations in pharmacy of hospital
Preparations in pharmacy of hospitalPreparations in pharmacy of hospital
Preparations in pharmacy of hospital
 
Injectable solutions
Injectable solutionsInjectable solutions
Injectable solutions
 
Aerosols
AerosolsAerosols
Aerosols
 

Recently uploaded

The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxmbikashkanyari
 
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCRashishs7044
 
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCRashishs7044
 
Guide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFGuide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFChandresh Chudasama
 
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCRashishs7044
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...ssuserf63bd7
 
Kenya Coconut Production Presentation by Dr. Lalith Perera
Kenya Coconut Production Presentation by Dr. Lalith PereraKenya Coconut Production Presentation by Dr. Lalith Perera
Kenya Coconut Production Presentation by Dr. Lalith Pereraictsugar
 
8447779800, Low rate Call girls in Rohini Delhi NCR
8447779800, Low rate Call girls in Rohini Delhi NCR8447779800, Low rate Call girls in Rohini Delhi NCR
8447779800, Low rate Call girls in Rohini Delhi NCRashishs7044
 
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCRashishs7044
 
Chapter 9 PPT 4th edition.pdf internal audit
Chapter 9 PPT 4th edition.pdf internal auditChapter 9 PPT 4th edition.pdf internal audit
Chapter 9 PPT 4th edition.pdf internal auditNhtLNguyn9
 
Market Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMarket Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMintel Group
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationAnamaria Contreras
 
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCRashishs7044
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfRbc Rbcua
 
Traction part 2 - EOS Model JAX Bridges.
Traction part 2 - EOS Model JAX Bridges.Traction part 2 - EOS Model JAX Bridges.
Traction part 2 - EOS Model JAX Bridges.Anamaria Contreras
 
Church Building Grants To Assist With New Construction, Additions, And Restor...
Church Building Grants To Assist With New Construction, Additions, And Restor...Church Building Grants To Assist With New Construction, Additions, And Restor...
Church Building Grants To Assist With New Construction, Additions, And Restor...Americas Got Grants
 
Digital Transformation in the PLM domain - distrib.pdf
Digital Transformation in the PLM domain - distrib.pdfDigital Transformation in the PLM domain - distrib.pdf
Digital Transformation in the PLM domain - distrib.pdfJos Voskuil
 
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607dollysharma2066
 
Flow Your Strategy at Flight Levels Day 2024
Flow Your Strategy at Flight Levels Day 2024Flow Your Strategy at Flight Levels Day 2024
Flow Your Strategy at Flight Levels Day 2024Kirill Klimov
 

Recently uploaded (20)

The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
 
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
 
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
 
Guide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFGuide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDF
 
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...
 
Kenya Coconut Production Presentation by Dr. Lalith Perera
Kenya Coconut Production Presentation by Dr. Lalith PereraKenya Coconut Production Presentation by Dr. Lalith Perera
Kenya Coconut Production Presentation by Dr. Lalith Perera
 
8447779800, Low rate Call girls in Rohini Delhi NCR
8447779800, Low rate Call girls in Rohini Delhi NCR8447779800, Low rate Call girls in Rohini Delhi NCR
8447779800, Low rate Call girls in Rohini Delhi NCR
 
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
 
Chapter 9 PPT 4th edition.pdf internal audit
Chapter 9 PPT 4th edition.pdf internal auditChapter 9 PPT 4th edition.pdf internal audit
Chapter 9 PPT 4th edition.pdf internal audit
 
Market Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMarket Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 Edition
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement Presentation
 
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR
8447779800, Low rate Call girls in New Ashok Nagar Delhi NCR
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdf
 
Traction part 2 - EOS Model JAX Bridges.
Traction part 2 - EOS Model JAX Bridges.Traction part 2 - EOS Model JAX Bridges.
Traction part 2 - EOS Model JAX Bridges.
 
Church Building Grants To Assist With New Construction, Additions, And Restor...
Church Building Grants To Assist With New Construction, Additions, And Restor...Church Building Grants To Assist With New Construction, Additions, And Restor...
Church Building Grants To Assist With New Construction, Additions, And Restor...
 
Digital Transformation in the PLM domain - distrib.pdf
Digital Transformation in the PLM domain - distrib.pdfDigital Transformation in the PLM domain - distrib.pdf
Digital Transformation in the PLM domain - distrib.pdf
 
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCREnjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
 
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
 
Flow Your Strategy at Flight Levels Day 2024
Flow Your Strategy at Flight Levels Day 2024Flow Your Strategy at Flight Levels Day 2024
Flow Your Strategy at Flight Levels Day 2024
 

GMP AND cGMP CONSIDERATIONS

  • 1. GMP AND cGMP CONSIDERATIONS Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D. Associate Professor Department of Pharmaceutics KLE University BELGAUM - 590010 By
  • 2.
  • 3.
  • 4.
  • 5.  
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12. QA, GMP & QC inter-relationship QC GMP QA
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.