Good Laboratory Management: Means compliance with the correct regulations for each individual...
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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 Facilities…160.43…
marine test organismsfreshwater test organismsplants [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 may…lead 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 world’s 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 sBusinesses….
• 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 Cytotoxicity—In 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
extractables
……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 ….
OECD…Organization 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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OECD Member Countries
An organisation with global reach
Working with countries around the world
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The OECD’s 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
Verification
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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.