Good Laboratory Management:

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

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EPA Good Laboratory Practices.. 40 CFR
160 Federal Insecticide, Fungicide and
Rodenticide Act FIFRA 40 CFR 792 Toxic
Substances Control Act TSCA
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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
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Minor differences do exist between EPA
and FDA Good Laboratory Practices.. Important
difference is 40 CFR 160.12 Statement of
compliance or non compliance.
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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
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40 CFR 160.17 Effects of
non- compliance Submission of a statement
required by 160.12 which is false maylead to
criminal prosecution
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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

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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

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EPA Quality Assurance Project Plan
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Be Aware of all regulations. Especially the
regulations for studies that your laboratory is
conducting !!!! Be a web warrior
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Other regulations . ISO International
Organization for Standardization is the worlds
largest developer of standards
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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
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• 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

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

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

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

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

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• 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

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• 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

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• 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

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

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

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• 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

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• 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

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• 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

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• 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

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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
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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
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Other regulations . OECDOrganization for
Economic Co-operation and Development
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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

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An organisation with global reach
OECD Member Countries


Working with countries around the world
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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

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Our environment

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

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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

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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

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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

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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

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Working with governments

• Sharing information and experience
• Country and region-based co-operation programmes
• Peer review and surveillance

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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

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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

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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

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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

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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

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OECD Quality Assurance and GLP Web site .OECD.org
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Quality Control Quality Assurance Validation Veri
fication
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• 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

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• 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

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• 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

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• 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

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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.
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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.