Good Laboratory Practices (http://www.ubio.in)
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Good Laboratory Practices (http://www.ubio.in)

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Introduction to good laboratory practices.

Introduction to good laboratory practices.
For more, visit: http://www.ubio.in

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Good Laboratory Practices (http://www.ubio.in) Good Laboratory Practices (http://www.ubio.in) Presentation Transcript

  • GOOD LABORATORY PRACTICE
  • Do, what you write Write, what you do
    • GLP goes hand-in-hand with QA (quality assurance)
    • GLP without quality is useless
    • USA: FEDERAL DRUG ADMINISTRATION
    •  1906: Food, Drug and Cosmetic Act FDA has to prove the poor quality for withdrawing a drug from the market
    •  1938: Manufacturer has to effectiveness of a drug
      •  1962: Manufacturer has to prove safety
      • and effectiveness of ‘New Drugs’
  • USA FEDERAL DRUG ADMINISTRATION  1979: Good Laboratory Practice Regulations (Revised several times)  Other agencies had endorsed the concept Eg: Environmental Protection Agency (EPA)
    • GLP is not an Act/Legislation/Statute
    • GLP is a regulation/guideline
  • Code of Federal regulations (Food and Drug Administration) Part 58
    • Good Laboratory practice for non-clinical
    • Laboratory studies
    • Organisation for Economic Co-operation and Development (OECD)
      • 1997
    • Principles of Good Laboratory Practice
    • Objective
    • To promote the quality and validity of test data used for determining the safety of chemicals and chemical products
  • Scope
      •  Industrial chemicals
    •  Pharmaceuticals
    •  Veterinary drugs
    •  Pesticides, Cosmetics
    •  Food additives preservatives
    •  Basic Research
    •  Any laboratory procedure
  • What GLP is not
      •  Excellence of a laboratory
    •  Quality of an organisation
    •  Quality of a product
    •  Professional competence
  • Then, what is GLP ? GLP indicates quality of a study/procedure.
  • Definition Good Laboratory Practice is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported (OECD, 1997)
  • Acceptability Credibility
  • Do not assume anything Good science = Compliance
  • Do not invent good practice
    • Compliance with national legislation
    • Compliance with national standards
    • Compliance with international standards
    • Validation of own standards
  • Terminology  Quality System  Quality and Requirement  Calibration and Traceability  Standard  Reference Material  Standardisation/validation  Accreditation  Inter-laboratory Comparison  Proficiency Testing  Auditing
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
  • QAC A quality policy A quality manual Control over all documents Quality atmosphere Well drafted ‘plan of action’
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
    • Study Director
    • Responsible for the study
    • Has control over everything
    • May have a ‘Principal investigator’
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
    • A written procedure for doing everything
    • SOP
    • Work instruction
    • Work procedure
    • work protocol
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
  • Facility
    • Equipment
    • Environment
    • Raw materials
    • Maintenance
    • Major Components
    •  Creation of QAC; QUALITY ASSURANCE UNIT
    •  Appointment of a STUDY DIRECTOR
    •  Need for written protocols; SOPs
      • STANDARD OPERATING PROCEDURES
      •  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
      •  Collection and analysis of data by QUALIFIED PERSONS
  • People problems
    • Unscientific
    • Untrained
    • Unaware
    • Unhelpful
  • GLP in action-I  Availability of written documents A place for everything and everything has a place Assessing quality of raw materials Maintenance of equipment Purchase of raw materials Authorisation to do receive, handle test materials Environmental monitoring Disposal of waste
  • GLP in action-II  Availability of written documents Entry restrictions Ensuring safety Authorisation to do receive, handle test materials Describing qualification/training requirements of staff Training of new personnel
  • GLP in action-III  Availability of written procedures/SOPs/protocols Receiving test materials Identifying (unique) samples Handling test materials Storing test materials Conducting each test Disposing materials Reporting results
  • GLP in action-IV  Documentation in approved formats Log book for equipment Data sheets for recording data Records of receipt, test procedures Approved report formats Compilation of data
  • GLP in action-V  Regular quality checks Auditing by qualified auditors Regular reporting of NCs and/or NICs Preventive and corrective actions
  • GLP in action-VI  Management commitment For ensuring high professional standards For up dating procedures according to changes in standards Participation in inter-laboratory comparisons Participation in proficiency testing
  • GLP in action-VII  Study Well defined study plan Well defined protocols Identification of critical stages Assured performance Reporting of deviations Compilation of data by qualified personnels Interpretation of data by professionals Archiving of materials/data/results
    • An auditors view
    • What was the task?
    • Why perform the task?
    • Who performed the task?
    • When was it done?
    • How was it recorded?
    • Planned Study
    • Quality Performance
    • Rigorous Monitoring
    • Unambiguous Records
    • Study Director’s Report
    • Archiving of materials
    Summary
  • Are we ready for GLP? We are ready, when we write what we do and when we do what we write, of course in compliance with national/international standards.