SlideShare a Scribd company logo
1 of 1
System built
Validation plan
URS (user
requirement
specification)
Design
specifications
Functional
specifications
Validation
report
Process
qualification
Operational
qualification
Installation
qualification
V-model concept of validation
s.gurubalaji@gmail.com

More Related Content

What's hot

Qualification & Validation
Qualification & ValidationQualification & Validation
Qualification & ValidationICHAPPS
 
CONCEPT OF URS, DQ, IQ, OQ, PQ
CONCEPT OF URS, DQ, IQ, OQ, PQCONCEPT OF URS, DQ, IQ, OQ, PQ
CONCEPT OF URS, DQ, IQ, OQ, PQROHIT
 
Process Validation of Liquid Orals
Process Validation of Liquid OralsProcess Validation of Liquid Orals
Process Validation of Liquid OralsAasawaree Yadav
 
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONValidation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONManikant Prasad Shah
 
Qualification of FBD.pptx
Qualification of FBD.pptxQualification of FBD.pptx
Qualification of FBD.pptxDhruvi50
 
Qualification of tablet compression (machine) & Capsule filling machine
Qualification of tablet compression (machine) & Capsule filling machineQualification of tablet compression (machine) & Capsule filling machine
Qualification of tablet compression (machine) & Capsule filling machineYash Menghani
 
What is a calibration master Plan?
What is a calibration master Plan?What is a calibration master Plan?
What is a calibration master Plan?MANUEL PACINI
 
Ipqc for parenterals
Ipqc for parenteralsIpqc for parenterals
Ipqc for parenteralsceutics1315
 
Validation Protocol
Validation ProtocolValidation Protocol
Validation ProtocolSagar Savale
 
Qualification of laboratory equipments
Qualification of laboratory equipmentsQualification of laboratory equipments
Qualification of laboratory equipmentsPranali Polshettiwar
 
Validation of dissolution apparatus
Validation of dissolution apparatusValidation of dissolution apparatus
Validation of dissolution apparatusShraddha Kumbhar
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationDhruviParmar
 
Pharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviPharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviRahul Dalvi
 
Process analytical technology
Process analytical technologyProcess analytical technology
Process analytical technologyanjalibharat19
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
EQUIPMENT QUALIFICATION.pptx
EQUIPMENT QUALIFICATION.pptxEQUIPMENT QUALIFICATION.pptx
EQUIPMENT QUALIFICATION.pptxRamkumar906213
 

What's hot (20)

Qualification & Validation
Qualification & ValidationQualification & Validation
Qualification & Validation
 
CONCEPT OF URS, DQ, IQ, OQ, PQ
CONCEPT OF URS, DQ, IQ, OQ, PQCONCEPT OF URS, DQ, IQ, OQ, PQ
CONCEPT OF URS, DQ, IQ, OQ, PQ
 
Water system validation
Water system validationWater system validation
Water system validation
 
Process validation ppt.
Process validation ppt.Process validation ppt.
Process validation ppt.
 
Process Validation of Liquid Orals
Process Validation of Liquid OralsProcess Validation of Liquid Orals
Process Validation of Liquid Orals
 
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONValidation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
 
Qualification of FBD.pptx
Qualification of FBD.pptxQualification of FBD.pptx
Qualification of FBD.pptx
 
Qualification of tablet compression (machine) & Capsule filling machine
Qualification of tablet compression (machine) & Capsule filling machineQualification of tablet compression (machine) & Capsule filling machine
Qualification of tablet compression (machine) & Capsule filling machine
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
What is a calibration master Plan?
What is a calibration master Plan?What is a calibration master Plan?
What is a calibration master Plan?
 
Ipqc for parenterals
Ipqc for parenteralsIpqc for parenterals
Ipqc for parenterals
 
Validation Protocol
Validation ProtocolValidation Protocol
Validation Protocol
 
Qualification of laboratory equipments
Qualification of laboratory equipmentsQualification of laboratory equipments
Qualification of laboratory equipments
 
Validation of dissolution apparatus
Validation of dissolution apparatusValidation of dissolution apparatus
Validation of dissolution apparatus
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
Pharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviPharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul Dalvi
 
Process analytical technology
Process analytical technologyProcess analytical technology
Process analytical technology
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validation
 
EQUIPMENT QUALIFICATION.pptx
EQUIPMENT QUALIFICATION.pptxEQUIPMENT QUALIFICATION.pptx
EQUIPMENT QUALIFICATION.pptx
 

More from Guru Balaji .S

Basic Candlestick Pattern in stock market, finance
Basic Candlestick Pattern in stock market, financeBasic Candlestick Pattern in stock market, finance
Basic Candlestick Pattern in stock market, financeGuru Balaji .S
 
Product registration procedure in USA
Product registration procedure in USAProduct registration procedure in USA
Product registration procedure in USAGuru Balaji .S
 
CMA-CPP-CQA for oral solid dosageform
CMA-CPP-CQA for oral solid dosageformCMA-CPP-CQA for oral solid dosageform
CMA-CPP-CQA for oral solid dosageformGuru Balaji .S
 
Specifications of process parameters and general ipc and finish product controls
Specifications of process parameters and general ipc and finish product controlsSpecifications of process parameters and general ipc and finish product controls
Specifications of process parameters and general ipc and finish product controlsGuru Balaji .S
 
Generics drug approval and timelines in china
Generics drug approval and timelines in chinaGenerics drug approval and timelines in china
Generics drug approval and timelines in chinaGuru Balaji .S
 
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)  Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV) Guru Balaji .S
 
Product development Global prospective
Product development   Global prospective Product development   Global prospective
Product development Global prospective Guru Balaji .S
 
Pharma figures 2017 ; Efpia
Pharma figures 2017 ; EfpiaPharma figures 2017 ; Efpia
Pharma figures 2017 ; EfpiaGuru Balaji .S
 
CTD ~ Common Technical Document
CTD ~ Common Technical DocumentCTD ~ Common Technical Document
CTD ~ Common Technical DocumentGuru Balaji .S
 
Points to be considered in topical formulation design
Points to be considered in topical formulation designPoints to be considered in topical formulation design
Points to be considered in topical formulation designGuru Balaji .S
 
Topicals product development NDA,ANDA
Topicals product development NDA,ANDATopicals product development NDA,ANDA
Topicals product development NDA,ANDAGuru Balaji .S
 
Comparasion of IND,NDA,BLA,ANDA,OTC
Comparasion of IND,NDA,BLA,ANDA,OTCComparasion of IND,NDA,BLA,ANDA,OTC
Comparasion of IND,NDA,BLA,ANDA,OTCGuru Balaji .S
 
Pharmaceutical QbD concepts for drug development
Pharmaceutical QbD concepts for drug developmentPharmaceutical QbD concepts for drug development
Pharmaceutical QbD concepts for drug developmentGuru Balaji .S
 

More from Guru Balaji .S (20)

Basic Candlestick Pattern in stock market, finance
Basic Candlestick Pattern in stock market, financeBasic Candlestick Pattern in stock market, finance
Basic Candlestick Pattern in stock market, finance
 
Water
WaterWater
Water
 
WO2017060920 a1
WO2017060920 a1WO2017060920 a1
WO2017060920 a1
 
Product registration procedure in USA
Product registration procedure in USAProduct registration procedure in USA
Product registration procedure in USA
 
CMA-CPP-CQA for oral solid dosageform
CMA-CPP-CQA for oral solid dosageformCMA-CPP-CQA for oral solid dosageform
CMA-CPP-CQA for oral solid dosageform
 
Specifications of process parameters and general ipc and finish product controls
Specifications of process parameters and general ipc and finish product controlsSpecifications of process parameters and general ipc and finish product controls
Specifications of process parameters and general ipc and finish product controls
 
Generics drug approval and timelines in china
Generics drug approval and timelines in chinaGenerics drug approval and timelines in china
Generics drug approval and timelines in china
 
ALCOA & ALCOA+
ALCOA & ALCOA+ALCOA & ALCOA+
ALCOA & ALCOA+
 
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)  Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)
 
Product development Global prospective
Product development   Global prospective Product development   Global prospective
Product development Global prospective
 
Pharma figures 2017 ; Efpia
Pharma figures 2017 ; EfpiaPharma figures 2017 ; Efpia
Pharma figures 2017 ; Efpia
 
Pharma analysis
Pharma analysisPharma analysis
Pharma analysis
 
CMA, CQA, CPP
CMA, CQA, CPPCMA, CQA, CPP
CMA, CQA, CPP
 
CTD ~ Common Technical Document
CTD ~ Common Technical DocumentCTD ~ Common Technical Document
CTD ~ Common Technical Document
 
5s
5s 5s
5s
 
Antibiotics
Antibiotics Antibiotics
Antibiotics
 
Points to be considered in topical formulation design
Points to be considered in topical formulation designPoints to be considered in topical formulation design
Points to be considered in topical formulation design
 
Topicals product development NDA,ANDA
Topicals product development NDA,ANDATopicals product development NDA,ANDA
Topicals product development NDA,ANDA
 
Comparasion of IND,NDA,BLA,ANDA,OTC
Comparasion of IND,NDA,BLA,ANDA,OTCComparasion of IND,NDA,BLA,ANDA,OTC
Comparasion of IND,NDA,BLA,ANDA,OTC
 
Pharmaceutical QbD concepts for drug development
Pharmaceutical QbD concepts for drug developmentPharmaceutical QbD concepts for drug development
Pharmaceutical QbD concepts for drug development
 

Recently uploaded

Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...
Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...
Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...anilsa9823
 
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsHubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsSérgio Sacani
 
Luciferase in rDNA technology (biotechnology).pptx
Luciferase in rDNA technology (biotechnology).pptxLuciferase in rDNA technology (biotechnology).pptx
Luciferase in rDNA technology (biotechnology).pptxAleenaTreesaSaji
 
Behavioral Disorder: Schizophrenia & it's Case Study.pdf
Behavioral Disorder: Schizophrenia & it's Case Study.pdfBehavioral Disorder: Schizophrenia & it's Case Study.pdf
Behavioral Disorder: Schizophrenia & it's Case Study.pdfSELF-EXPLANATORY
 
Nanoparticles synthesis and characterization​ ​
Nanoparticles synthesis and characterization​  ​Nanoparticles synthesis and characterization​  ​
Nanoparticles synthesis and characterization​ ​kaibalyasahoo82800
 
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...jana861314
 
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...Lokesh Kothari
 
Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)PraveenaKalaiselvan1
 
Biological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfBiological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfmuntazimhurra
 
Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )aarthirajkumar25
 
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Sérgio Sacani
 
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdf
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdfNAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdf
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdfWadeK3
 
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝soniya singh
 
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.aasikanpl
 
Cultivation of KODO MILLET . made by Ghanshyam pptx
Cultivation of KODO MILLET . made by Ghanshyam pptxCultivation of KODO MILLET . made by Ghanshyam pptx
Cultivation of KODO MILLET . made by Ghanshyam pptxpradhanghanshyam7136
 
VIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PVIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PPRINCE C P
 
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptx
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptxSOLUBLE PATTERN RECOGNITION RECEPTORS.pptx
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptxkessiyaTpeter
 
G9 Science Q4- Week 1-2 Projectile Motion.ppt
G9 Science Q4- Week 1-2 Projectile Motion.pptG9 Science Q4- Week 1-2 Projectile Motion.ppt
G9 Science Q4- Week 1-2 Projectile Motion.pptMAESTRELLAMesa2
 

Recently uploaded (20)

Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...
Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...
Lucknow 💋 Russian Call Girls Lucknow Finest Escorts Service 8923113531 Availa...
 
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsHubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
 
Luciferase in rDNA technology (biotechnology).pptx
Luciferase in rDNA technology (biotechnology).pptxLuciferase in rDNA technology (biotechnology).pptx
Luciferase in rDNA technology (biotechnology).pptx
 
Engler and Prantl system of classification in plant taxonomy
Engler and Prantl system of classification in plant taxonomyEngler and Prantl system of classification in plant taxonomy
Engler and Prantl system of classification in plant taxonomy
 
Behavioral Disorder: Schizophrenia & it's Case Study.pdf
Behavioral Disorder: Schizophrenia & it's Case Study.pdfBehavioral Disorder: Schizophrenia & it's Case Study.pdf
Behavioral Disorder: Schizophrenia & it's Case Study.pdf
 
Nanoparticles synthesis and characterization​ ​
Nanoparticles synthesis and characterization​  ​Nanoparticles synthesis and characterization​  ​
Nanoparticles synthesis and characterization​ ​
 
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...
Traditional Agroforestry System in India- Shifting Cultivation, Taungya, Home...
 
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
 
Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)
 
Biological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfBiological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdf
 
Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )
 
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
 
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdf
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdfNAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdf
NAVSEA PEO USC - Unmanned & Small Combatants 26Oct23.pdf
 
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Munirka Delhi 💯Call Us 🔝8264348440🔝
 
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.
Call Girls in Munirka Delhi 💯Call Us 🔝9953322196🔝 💯Escort.
 
The Philosophy of Science
The Philosophy of ScienceThe Philosophy of Science
The Philosophy of Science
 
Cultivation of KODO MILLET . made by Ghanshyam pptx
Cultivation of KODO MILLET . made by Ghanshyam pptxCultivation of KODO MILLET . made by Ghanshyam pptx
Cultivation of KODO MILLET . made by Ghanshyam pptx
 
VIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PVIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C P
 
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptx
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptxSOLUBLE PATTERN RECOGNITION RECEPTORS.pptx
SOLUBLE PATTERN RECOGNITION RECEPTORS.pptx
 
G9 Science Q4- Week 1-2 Projectile Motion.ppt
G9 Science Q4- Week 1-2 Projectile Motion.pptG9 Science Q4- Week 1-2 Projectile Motion.ppt
G9 Science Q4- Week 1-2 Projectile Motion.ppt
 

V-model validation concept system design

  • 1. System built Validation plan URS (user requirement specification) Design specifications Functional specifications Validation report Process qualification Operational qualification Installation qualification V-model concept of validation s.gurubalaji@gmail.com