SlideShare a Scribd company logo

GMP AND cGMP CONSIDERATIONS

•Download as PPT, PDF•
•
Prof. Dr. Basavaraj Nanjwade
Prof. Dr. Basavaraj Nanjwade
BusinessTechnology
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

Recommended

Glp 112070804004
Glp 112070804004Glp 112070804004
Glp 112070804004Patel Parth
 
Master formula record
Master formula recordMaster formula record
Master formula recordPranali Palandurkar
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practiceDr Subodh Satheesh
 
BMR (Batch Manufacturing Record)
BMR (Batch Manufacturing Record)BMR (Batch Manufacturing Record)
BMR (Batch Manufacturing Record)Ram Mohan S R
 
MFR
MFRMFR
MFRCHHATTISGARH SWAMI VIVEKANAND TECHNICHAL UNIVERSITY , BHILAI
 
USFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesUSFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesswrk
 
cGMP.
cGMP.cGMP.
cGMP.Gaurav kumar
 
BATCH MANUFACTURING RECORD
BATCH MANUFACTURING RECORDBATCH MANUFACTURING RECORD
BATCH MANUFACTURING RECORDchandamalviya
 

Recommended

Glp 112070804004
Glp 112070804004Glp 112070804004
Glp 112070804004Patel Parth
 
Master formula record
Master formula recordMaster formula record
Master formula recordPranali Palandurkar
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practiceDr Subodh Satheesh
 
BMR (Batch Manufacturing Record)
BMR (Batch Manufacturing Record)BMR (Batch Manufacturing Record)
BMR (Batch Manufacturing Record)Ram Mohan S R
 
MFR
MFRMFR
MFRCHHATTISGARH SWAMI VIVEKANAND TECHNICHAL UNIVERSITY , BHILAI
 
USFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesUSFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesswrk
 
cGMP.
cGMP.cGMP.
cGMP.Gaurav kumar
 
BATCH MANUFACTURING RECORD
BATCH MANUFACTURING RECORDBATCH MANUFACTURING RECORD
BATCH MANUFACTURING RECORDchandamalviya
 
Ich guideline for stability testing
Ich guideline for stability testingIch guideline for stability testing
Ich guideline for stability testingShubham Gore
 
Good Manufacturing Practices for Pharmaceuticals
Good Manufacturing Practices for PharmaceuticalsGood Manufacturing Practices for Pharmaceuticals
Good Manufacturing Practices for PharmaceuticalsProf. Dr. Basavaraj Nanjwade
 
Complaint and recall handling
Complaint and recall handlingComplaint and recall handling
Complaint and recall handlingDolly Gabriola
 
Qualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETERQualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETERDr.K.Venkateswara raju
 
ICH Guidelines
ICH GuidelinesICH Guidelines
ICH GuidelinesTeny Thomas
 
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCQUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
 
Validation master plan
Validation master planValidation master plan
Validation master planRaghavendra institute of pharmaceutical education and research .
 
BMR & MFR
BMR & MFRBMR & MFR
BMR & MFRDr.K.Venkateswara raju
 
Master formula record
Master formula recordMaster formula record
Master formula recordDoninder Hooda
 
Validation master plan
Validation master planValidation master plan
Validation master planPriyanka Kandhare
 
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...SimranKukreja4
 
types of validation
types of validation types of validation
types of validation AbdulNaim14
 
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTIONPHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTIONPrincy Agarwal
 
Gmp
GmpGmp
GmpMalla Reddy College of Pharmacy
 
Documentation in Pharmaceutical Industry
Documentation in Pharmaceutical IndustryDocumentation in Pharmaceutical Industry
Documentation in Pharmaceutical IndustryNavaneethakrishnan Palaniappan
 
Document Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical IndustryDocument Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
 
Indian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP CertificationIndian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP CertificationVishal Shelke
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
Validation master plan
Validation master planValidation master plan
Validation master planDr. Amsavel A
 
ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)AshwiniBawankule
 
Reaction intermediates
Reaction intermediatesReaction intermediates
Reaction intermediatesDr. Tanuja Nautiyal
 
Pyrogen testing
Pyrogen testingPyrogen testing
Pyrogen testingnilesh1208
 

More Related Content

What's hot

Ich guideline for stability testing
Ich guideline for stability testingIch guideline for stability testing
Ich guideline for stability testingShubham Gore
 
Complaint and recall handling
Complaint and recall handlingComplaint and recall handling
Complaint and recall handlingDolly Gabriola
 
Qualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETERQualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETERDr.K.Venkateswara raju
 
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCQUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
 
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...SimranKukreja4
 
types of validation
types of validation types of validation
types of validation AbdulNaim14
 
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTIONPHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTIONPrincy Agarwal
 
Document Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical IndustryDocument Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
 
Indian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP CertificationIndian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP CertificationVishal Shelke
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
Validation master plan
Validation master planValidation master plan
Validation master planDr. Amsavel A
 

What's hot (20)

Ich guideline for stability testing
Ich guideline for stability testingIch guideline for stability testing
Ich guideline for stability testing
 
Good Manufacturing Practices for Pharmaceuticals
Good Manufacturing Practices for PharmaceuticalsGood Manufacturing Practices for Pharmaceuticals
Good Manufacturing Practices for Pharmaceuticals
 
Complaint and recall handling
Complaint and recall handlingComplaint and recall handling
Complaint and recall handling
 
Qualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETERQualification of UV VISIBLE SPECTROPHOTOMETER
Qualification of UV VISIBLE SPECTROPHOTOMETER
 
ICH Guidelines
ICH GuidelinesICH Guidelines
ICH Guidelines
 
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCQUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
BMR & MFR
BMR & MFRBMR & MFR
BMR & MFR
 
Master formula record
Master formula recordMaster formula record
Master formula record
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
 
types of validation
types of validation types of validation
types of validation
 
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTIONPHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
PHARMACEUTICAL CALIBRATION, QUALIFICATION AND VALIDATION: AN INTRODUCTION
 
Gmp
GmpGmp
Gmp
 
Documentation in Pharmaceutical Industry
Documentation in Pharmaceutical IndustryDocumentation in Pharmaceutical Industry
Documentation in Pharmaceutical Industry
 
Document Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical IndustryDocument Maintenance in Pharmaceutical Industry
Document Maintenance in Pharmaceutical Industry
 
Indian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP CertificationIndian GMP Certification & WHO GMP Certification
Indian GMP Certification & WHO GMP Certification
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validation
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)
 

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
 
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 (7)

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
 
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

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
 
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
 
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptx
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptxQSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptx
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptxDitasDelaCruz
 
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...Falcon Invoice Discounting
 
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannaBusinessPlans
 
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSCROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSpanmisemningshen123
 
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
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPanhandleOilandGas
 
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...pujan9679
 
Falcon Invoice Discounting: Unlock Your Business Potential
Falcon Invoice Discounting: Unlock Your Business PotentialFalcon Invoice Discounting: Unlock Your Business Potential
Falcon Invoice Discounting: Unlock Your Business PotentialFalcon investment
 
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
 
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTS
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTSJAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTS
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTSkajalroy875762
 
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
 
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGBerhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGpr788182
 
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGBerhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGpr788182
 
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
 
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityHow to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityEric T. Tung
 
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
 

Recently uploaded (20)

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
 
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
 
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptx
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptxQSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptx
QSM Chap 10 Service Culture in Tourism and Hospitality Industry.pptx
 
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
 
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 Updated
 
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NSCROSS CULTURAL NEGOTIATION BY PANMISEM NS
CROSS CULTURAL NEGOTIATION BY PANMISEM NS
 
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
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation Final
 
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...
Ooty Call Gril 80022//12248 Only For Sex And High Profile Best Gril Sex Avail...
 
Falcon Invoice Discounting: Unlock Your Business Potential
Falcon Invoice Discounting: Unlock Your Business PotentialFalcon Invoice Discounting: Unlock Your Business Potential
Falcon Invoice Discounting: Unlock Your Business Potential
 
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
 
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTS
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTSJAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTS
JAJPUR CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN JAJPUR ESCORTS
 
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
 
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGBerhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
 
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGBerhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
 
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
 
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityHow to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League City
 
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
 
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
 
WheelTug Short Pitch Deck 2024 | Byond Insights
WheelTug Short Pitch Deck 2024 | Byond InsightsWheelTug Short Pitch Deck 2024 | Byond Insights
WheelTug Short Pitch Deck 2024 | Byond Insights
 

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.