Environmental Protection Agency

Transcription

1 Good Laboratory Management: Means compliance with the correct regulations for each individual study.. Environmental Protection Agency Established 1970 To enforce environmental protection standards Clean Air Act 1970 Clean Water Act 1973 EPA Good Laboratory Practices.. 40 CFR 160 Federal Insecticide, Fungicide and Rodenticide Act [FIFRA] 40 CFR 792 Toxic Substances Control Act [TSCA] Minor differences do exist between EPA and FDA Good Laboratory Practices.. Difference from FDA. Test System Care Facilities marine test organisms freshwater test organisms plants [field studies] Regulations. FIFRA 40 CFR 160 standards specify minimum practices and procedures which must be followed in order to ensure the quality and integrity of data submitted to EPA in support of a research or marketing permit for a pesticide product. Regulations. Compliance with EPA s FIFRA and TSCA GLP standards are monitored through a program of laboratory inspections and study audits coordinated between EPA and FDA. 1

2 Minor differences do exist between EPA and FDA Good Laboratory Practices.. Important difference is 40 CFR : Statement of compliance or non compliance. 40 CFR : 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 Civil Penalties 40 CFR : Effects of noncompliance Submission of a statement required by which is false may lead to criminal prosecution 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 High Level GLP Civil Penalties cont. 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 2

3 EPA Quality Assurance Project Plan 3

4 Be Aware of all regulations. Especially the regulations for studies that your laboratory is conducting!!!! Be a web warrior Other regulations. ISO [International Organization for Standardization] is the world s largest developer of standards 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 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 International standardization began in the electrotechnical field.. International Electrotechnical Commission [IEC] established 1906 In 1946 delegates from 25 countries..created a new international organization to facilitate the international coordination and unification of industrial standards This new organization ISO officially began operations in

5 When the large majority of products or services.. Conform to International Standards, a state of industry wide standardization can be said to exist. This is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned.. suppliers users government regulators consumers 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 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 Benefits 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 Customers compatibility of technology brings an increasingly wide choice of offers benefit from the effects of competition among suppliers 5

6 Governments provide the technological and scientific bases underpinning health, safety and environmental legislation 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 ISO Biological Evaluation of Medical Devices Guidance on Selection of Tests Animal Welfare Requirements Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity Selection of Tests for Interactions with Blood ISO Biological Evaluation of Medical Devices Tests for Cytotoxicity In Vitro Methods Tests for Local Effects after Implantation Ethylene Oxide Sterilization Residuals Degradation of Materials Related to Biological Testing ISO Biological Evaluation of Medical Devices Tests for Irritation and Sensitization Tests for Systemic Toxicity Sample Preparation and Reference Materials ISO 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 6

7 ISO 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 Other regulations. OECD Organization for Economic Co-operation and Development 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 An organisation with global reach OECD Member Countries Working with countries around the world 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 Environment Make markets work for a healthier environment Use science and technology to benefit people everywhere Cut wastage and pollution 7

8 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 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 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 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 OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring No 1: OECD Principles on Good Laboratory Practice 8