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Good Laboratory Management:

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Good Laboratory Management: Means compliance with the correct regulations for each individual study .. – PowerPoint PPT presentation

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Title: Good Laboratory Management:


1
  • Good Laboratory Management
  • Means compliance with the correct regulations for
    each individual study..

2
EPA Good Laboratory Practices.. 40 CFR
160 Federal Insecticide, Fungicide and
Rodenticide Act FIFRA 40 CFR 792 Toxic
Substances Control Act TSCA
3
Minor differences do exist between EPA
and FDA Good Laboratory Practices.. Difference
from FDA. Test System Care Facilities160.43
marine test organisms freshwater test
organisms plants field studies
4
Minor differences do exist between EPA
and FDA Good Laboratory Practices.. Important
difference is 40 CFR 160.12 Statement of
compliance or non compliance.
5
40 CFR 160.12 Statement of compliance
or non compliance Application must contain a
statement signed by the applicant, sponsor, and
SD that (a) study was conducted according to
40CFR160 or (b) describe in detail all
differences between the practices used in study
and those required..or (c) a statement that the
study was not conducted in accordance to
40CFR160
6
40 CFR 160.17 Effects of
non- compliance Submission of a statement
required by 160.12 which is false maylead to
criminal prosecution
7
Civil Penalties
  • High Level GLP Violations
  • Failure to notify contractors of GLP
    applicability
  • Failure to keep personnel records
  • Failure to designate a Study Director
  • Failure to assure existence of a QAU
  • Failure of QA to perform inspections and maintain
    records
  • Failure to maintain SOPs

8
Civil Penalties cont.
  • High Level GLP
  • Failure to follow SOPS without proper
    authorization
  • Failure to characterize test materials
  • Unauthorized protocol deviations
  • Failure to record raw data failure to retain raw
    data
  • Falsification of raw data

9
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14
EPA Quality Assurance Project Plan
15
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16
Be Aware of all regulations. Especially the
regulations for studies that your laboratory is
conducting !!!! Be a web warrior
17
Other regulations . ISO International
Organization for Standardization is the worlds
largest developer of standards
18
What are ISO 9000 standards. A collection of
formal International Standards, Technical
Specifications, Technical Reports, Handbooks and
web based documents on Quality Management and
Quality Assurance www.iso.org
19
  • ISO is a network of the national standards
    institutes of 156 countries
  • A Central Secretariat in Geneva,
    Switzerland.that coordinates the system
  • One member per country

20
  • International standardization began in the
    electrotechnical field..
  • International Electrotechnical Commission IEC
    established 1906
  • In 1946 delegates from 25 countries ..created a
    new international organization

21
  • to facilitate the international coordination
    and unification of industrial standards
  • This new organization ISO officially began
    operations in 1947

22
  • When the large majority of products or services
    ..
  • Conform to International Standards, a state of
    industry wide standardization can be said to
    exist.

23
  • This is achieved through consensus agreements
    between national delegations representing all the
    economic stakeholders concerned..
  • suppliers
  • users
  • government regulators
  • consumers

24
  • Agreement on specifications and criteria to
    be applied consistently in the .
  • manufacture and supply of products
  • testing and analysis
  • classification of materials
  • terminology
  • provision of services

25
  • So
  • International Standards provide a reference
    framework or a common technological language
    between suppliers and their customers which
    facilitates trade and the transfer of technology

26
  • Benefit s
  • Businesses.
  • can base development of their products and
    services on specifications that have acceptance
    in their sectors
  • means businesses that use ISO standards are
    increasingly free to compete on many more markets
    around the world

27
  • Customers
  • compatibility of technology
  • brings an increasingly wide choice of offers
  • benefit from the effects of competition among
    suppliers

28
  • Governments
  • provide the technological and scientific bases
    underpinning health, safety and environmental
    legislation

29
  • Trade Officials
  • Negotiating the emergence of regional and
    global markets..creates a level playing field
    for all competitors on those markets
  • ISO standards are the technical means by which
    political trade agreements can be put into
    practice

30
  • ISO 10993 Biological Evaluation of Medical
    Devices
  • 10993-1 Guidance on Selection of Tests
  • 10993-2 Animal Welfare Requirements
  • 10993-3 Tests for Genotoxicity,
    Carcinogenicity, and Reproductive Toxicity
  • 10993-4 Selection of Tests for
    Interactions with Blood

31
  • ISO 10993 Biological Evaluation of Medical
    Devices
  • 10993- 5 Tests for CytotoxicityIn Vitro
    Methods
  • 10993-6 Tests for Local Effects after
    Implantation
  • 10993-7 Ethylene Oxide Sterilization
    Residuals
  • 10993-9 Degradation of Materials Related
    to Biological Testing

32
  • ISO 10993 Biological Evaluation of Medical
    Devices
  • 10993- 10 Tests for Irritation and
    Sensitization
  • 10993- 11 Tests for Systemic Toxicity
  • 10993- 12 Sample Preparation and Reference
    Materials

33
ISO 10993-1 Excellent guidelines for considering
the safety of medical devices Materials should
be characterized to provide an understanding
of formulation potential impurities extractabl
es to provide the basis for
specifications
34
ISO 10993-1 Testing should be conducted
according to good laboratory practices and
evaluated by competent informed persons Full
experimental data should be made available to
reviewing authorities All relevant data,
including information from nonclinical sources,
clinical studies and postmarket experiences,
should be taken into account when evaluating a
device
35
Other regulations . OECDOrganization for
Economic Co-operation and Development
36
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37
What is the OECD?
  • An Organisation of 30 member countries committed
    to democracy and the market economy
  • A provider of comparative data, analysis and
    forecasts
  • So that governments can
  • - compare policy experiences
  • - seek answers to common problems
  • - identify good practice
  • - co-ordinate policies

38

An organisation with global reach
OECD Member Countries


Working with countries around the world
39
The OECDs mission
  • Article 1 of the OECD Convention
  • Support economic growth
  • Boost employment
  • Raise living standards
  • Maintain financial stability
  • Assist other countries economic development
  • Contribute to growth in world trade

40
Our environment
  • Make markets work for a healthier environment
  • Use science and technology to benefit people
    everywhere
  • Cut wastage and pollution

41
Economics and trade
  • Analyse and publish comparative data
  • Produce forecasts
  • Develop policies for growth and stability
  • Foster open markets
  • Encourage expansion of financial services
  • Promote cross-border investment
  • Share best practices

42
Social cohesion
  • Ensure equal access to education for all
  • Promote effective and accessible health systems
  • Fight social exclusion and unemployment
  • Bridge the digital divide between rich and poor

43
Governance
  • Promote effective public administration
  • Encourage companies to run their affairs better
  • Ensure transparent and fair tax systems
  • Foster fair competition
  • Fight corruption and money-laundering
  • Promote high ethical standards
  • Encourage citizen-participation in policy-making

44
The OECD Secretariat
  • Two official languages English and French
  • Staff members are international civil servants
  • No quota system for national representation
  • 2300 staff at Paris headquarter

45
Working with governments
  • Sharing information and experience
  • Country and region-based co-operation programmes
  • Peer review and surveillance

46
Working with civil society
  • Consulting with business
  • represented by the Business and Industry
    Advisory Committee
  • Consulting with labour
  • represented by the Trade Union Advisory
    Committe
  • Expanding relations with civil society
  • Making information available to the public on
    www.oecd.org

47
Social cohesion
  • Helping to ensure equal access to education for
    all
  • Promoting effective and accessible health systems
  • Fighting social exclusion and unemployment
  • Bridging the digital divide between rich and
    poor

48
Our environment
  • Making markets work for ecologically and
    economically sustainable development
  • Harnessing science and technology in the service
    of citizens in all countries
  • Strengthening decision-making to avoid wastage
    and pollution

49
Governance
  • Promoting good governance at all levels of
    government and corporate activity
  • Ensuring transparency and fairness in tax systems
    and competition rules
  • Fighting corruption and money-laundering and
    promoting high ethical standards
  • Supporting accountability and encouraging
    citizen-participation in policy-making

50
Some OECD achievements
  • DAC Guidelines for Poverty Reduction
  • OECD Model Tax Convention
  • OECD Anti-Bribery Convention
  • OECD Principles of Corporate Governance
  • OECD Guidelines for Multinational Enterprises
  • Export Credit Arrangement
  • OECD Guidelines for Conflict Prevention
  • OECD Chemicals Test Acceptance Agreement
  • OECD Chemical Hazard Classification System
  • OECD GM Crop Identification System

51
OECD Quality Assurance and GLP Web site .OECD.org
52
Quality Control Quality Assurance Validation Veri
fication
53
  • Quality Control
  • Planned activities designed to produce a
    quality product ..
  • Tools a scientist uses to measure accuracy and
    precision, and reduce variability
  • Assuring that calibration procedures prove
    equipment accuracy
  • Assuring equipment is reliable and gives
    reliable data

54
  • Quality Control
  • Verifying all transcribed data as accurate
  • Assuring protocol required items are documented
    in data
  • Assuring data stands alone enough detail is
    available when needed calculations are correct
  • Assuring that data are complete, easy to read
    and follow
  • Assure that checklists are dated and initialed

55
  • Quality Assurance
  • Activities designed to ensure that quality
    control procedures are functioning as intended
  • Assuring protocols are followed
  • Assuring deviations are documented and reported
  • Assuring personnel are property trained
  • Assuring that equipment is as specified in the
    protocol

56
  • Quality Assurance
  • Assuring management that systems are functioning
    as intended
  • Assuring that study events are adequately
    documented
  • Assuring that the final report ACCURATELY
    reflects the raw data

57
QA Issues Validation The action of proving that
a procedure, process, system, equipment, or
method works as expected and achieves the
intended result over time.
58
QA Issues Verification A one-time process
completed before the test system is used.
Requires determination or confirmation of the
test performance characteristics, including
sensitivity, specificity, and where appropriate,
the predictive values, precision and accuracy of
the test.
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