SlideShare a Scribd company logo
1 of 5
Presented by
     Pragnesh Panchamvedi
M.S.Pharm Regulatory Toxicology
     NIPER-Mohali, INDIA
Under G.L.P. Regulation it is possible to conduct
         precisely a set of useless test
A process management focus would encourage
statistical process control methods. Process
thinking leads to root cause analysis of problems &
systemic elimination of error in future experiments
Outcome of audit is partly function of people who do the
inspection quality emerges when people strive continually
to improove their tools & processes
Limitations Of G.L.P.

More Related Content

What's hot

PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATIONSACHIN C P
 
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxTOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxAnmolkanda06
 
Potentiometry1 for mpharm ist sem notes
Potentiometry1 for mpharm ist sem notes Potentiometry1 for mpharm ist sem notes
Potentiometry1 for mpharm ist sem notes prakash64742
 
Immunoassay of insulin (neha)
Immunoassay of insulin (neha)Immunoassay of insulin (neha)
Immunoassay of insulin (neha)ANANYAPANDEY71
 
Microsomal assays toxicokinetics taxicokinetic evaluation in preclinical st...
Microsomal assays  toxicokinetics  taxicokinetic evaluation in preclinical st...Microsomal assays  toxicokinetics  taxicokinetic evaluation in preclinical st...
Microsomal assays toxicokinetics taxicokinetic evaluation in preclinical st...siva ganesh
 
Development and Validation of a RP-HPLC method
Development and Validation of a RP-HPLC methodDevelopment and Validation of a RP-HPLC method
Development and Validation of a RP-HPLC methodUshaKhanal3
 
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)'
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)' A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)'
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)' Sanathoiba Singha
 
Sample preparation and protocols in metabolite identification
Sample preparation and protocols in metabolite identificationSample preparation and protocols in metabolite identification
Sample preparation and protocols in metabolite identificationDurgadevi Ganesan
 
Screening models for inflammatory drugs
Screening models for inflammatory drugsScreening models for inflammatory drugs
Screening models for inflammatory drugsMy_VivJaan
 
Target discovery and validation
Target discovery and validation Target discovery and validation
Target discovery and validation ANAND SAGAR TIWARI
 
Preclinical screening of antiallergics
Preclinical screening of antiallergicsPreclinical screening of antiallergics
Preclinical screening of antiallergicsPrajitha p
 
OECD Guideline For Acute oral toxicity (TG 423)
OECD Guideline For Acute oral toxicity (TG 423)OECD Guideline For Acute oral toxicity (TG 423)
OECD Guideline For Acute oral toxicity (TG 423)Naveen K L
 
Pre clinical screening models for drugs acting on Autonomic nervous system
Pre clinical screening models for drugs acting on Autonomic nervous systemPre clinical screening models for drugs acting on Autonomic nervous system
Pre clinical screening models for drugs acting on Autonomic nervous systemRana Rana
 
Screening Methods for behavioural and muscle Coordination
 Screening Methods for behavioural and muscle Coordination Screening Methods for behavioural and muscle Coordination
Screening Methods for behavioural and muscle Coordinationpradnya Jagtap
 

What's hot (20)

Factors Affecting Resolution In HPLC.
Factors Affecting Resolution In HPLC.Factors Affecting Resolution In HPLC.
Factors Affecting Resolution In HPLC.
 
Mass analyzers
Mass analyzersMass analyzers
Mass analyzers
 
Concept of non linear and linear pharmacokinetic model
Concept of non linear and linear pharmacokinetic modelConcept of non linear and linear pharmacokinetic model
Concept of non linear and linear pharmacokinetic model
 
PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATION
 
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxTOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
 
GENOTOXICITY STUDIES(as per OECD)
GENOTOXICITY STUDIES(as per OECD)GENOTOXICITY STUDIES(as per OECD)
GENOTOXICITY STUDIES(as per OECD)
 
good laboratory practices
 good laboratory practices good laboratory practices
good laboratory practices
 
Potentiometry1 for mpharm ist sem notes
Potentiometry1 for mpharm ist sem notes Potentiometry1 for mpharm ist sem notes
Potentiometry1 for mpharm ist sem notes
 
Immunoassay of insulin (neha)
Immunoassay of insulin (neha)Immunoassay of insulin (neha)
Immunoassay of insulin (neha)
 
Microsomal assays toxicokinetics taxicokinetic evaluation in preclinical st...
Microsomal assays  toxicokinetics  taxicokinetic evaluation in preclinical st...Microsomal assays  toxicokinetics  taxicokinetic evaluation in preclinical st...
Microsomal assays toxicokinetics taxicokinetic evaluation in preclinical st...
 
Development and Validation of a RP-HPLC method
Development and Validation of a RP-HPLC methodDevelopment and Validation of a RP-HPLC method
Development and Validation of a RP-HPLC method
 
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)'
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)' A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)'
A collection of notes for the subject 'Modern Pharmaceutical Analysis (MPA)'
 
Sample preparation and protocols in metabolite identification
Sample preparation and protocols in metabolite identificationSample preparation and protocols in metabolite identification
Sample preparation and protocols in metabolite identification
 
Screening models for inflammatory drugs
Screening models for inflammatory drugsScreening models for inflammatory drugs
Screening models for inflammatory drugs
 
Target discovery and validation
Target discovery and validation Target discovery and validation
Target discovery and validation
 
Preclinical screening of antiallergics
Preclinical screening of antiallergicsPreclinical screening of antiallergics
Preclinical screening of antiallergics
 
OECD Guideline For Acute oral toxicity (TG 423)
OECD Guideline For Acute oral toxicity (TG 423)OECD Guideline For Acute oral toxicity (TG 423)
OECD Guideline For Acute oral toxicity (TG 423)
 
Pre clinical screening models for drugs acting on Autonomic nervous system
Pre clinical screening models for drugs acting on Autonomic nervous systemPre clinical screening models for drugs acting on Autonomic nervous system
Pre clinical screening models for drugs acting on Autonomic nervous system
 
Screening models of Anti diabetics.
Screening models of Anti diabetics.Screening models of Anti diabetics.
Screening models of Anti diabetics.
 
Screening Methods for behavioural and muscle Coordination
 Screening Methods for behavioural and muscle Coordination Screening Methods for behavioural and muscle Coordination
Screening Methods for behavioural and muscle Coordination
 

Viewers also liked

1.6 동적인 형 정보
1.6 동적인 형 정보1.6 동적인 형 정보
1.6 동적인 형 정보준섭 김
 
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...dcambrid
 
Digital format of research paper
Digital format of research paperDigital format of research paper
Digital format of research papercbouche3
 
Chaguaramas breakfast meeting, April 8th 2011
Chaguaramas breakfast meeting, April 8th 2011Chaguaramas breakfast meeting, April 8th 2011
Chaguaramas breakfast meeting, April 8th 2011Shrmtt MemberForum
 
National Civic Summit - National Museum Of The American Indian
National Civic Summit - National Museum Of The American IndianNational Civic Summit - National Museum Of The American Indian
National Civic Summit - National Museum Of The American IndianNational Civic Summit
 
Study: The Future of VR, AR and Self-Driving Cars
Study: The Future of VR, AR and Self-Driving CarsStudy: The Future of VR, AR and Self-Driving Cars
Study: The Future of VR, AR and Self-Driving CarsLinkedIn
 

Viewers also liked (7)

1.6 동적인 형 정보
1.6 동적인 형 정보1.6 동적인 형 정보
1.6 동적인 형 정보
 
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...
Digital Literacy, Ownership, and Legitimacy: How Controversy about the Nati...
 
Digital format of research paper
Digital format of research paperDigital format of research paper
Digital format of research paper
 
Etan Schwartz
Etan SchwartzEtan Schwartz
Etan Schwartz
 
Chaguaramas breakfast meeting, April 8th 2011
Chaguaramas breakfast meeting, April 8th 2011Chaguaramas breakfast meeting, April 8th 2011
Chaguaramas breakfast meeting, April 8th 2011
 
National Civic Summit - National Museum Of The American Indian
National Civic Summit - National Museum Of The American IndianNational Civic Summit - National Museum Of The American Indian
National Civic Summit - National Museum Of The American Indian
 
Study: The Future of VR, AR and Self-Driving Cars
Study: The Future of VR, AR and Self-Driving CarsStudy: The Future of VR, AR and Self-Driving Cars
Study: The Future of VR, AR and Self-Driving Cars
 

Limitations Of G.L.P.

  • 1. Presented by Pragnesh Panchamvedi M.S.Pharm Regulatory Toxicology NIPER-Mohali, INDIA
  • 2. Under G.L.P. Regulation it is possible to conduct precisely a set of useless test
  • 3. A process management focus would encourage statistical process control methods. Process thinking leads to root cause analysis of problems & systemic elimination of error in future experiments
  • 4. Outcome of audit is partly function of people who do the inspection quality emerges when people strive continually to improove their tools & processes