Good laboratory practice is not only concerned with production, but also quality control. This part prescribes good laboratory practices for conducting nonclinical laboratory. Glp good laboratory practice guidelines in academic and clinical research. This allows you to be informed of risks and precautions to take, while being trained in some basic practices used in the laboratory. Good laboratory practice training manual for the trainer. Guidance document nonclinical laboratory study data. Good laboratory practice for nonclinical laboratory. Good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits. Glp good laboratory practice guidelines in academic and. Good laboratory practices ephy khaemba eohs research compliance manager ilri glp. Good laboratory practice glp glp is a formal regulation created by usfda as these regulations were proposed on november 19,1976 and designated as a new part of chapter 21 of the code of federal regulations cfr as 21 cfr part 58 in 1979.
Apr 01, 2019 the information on this page is current as of april 1 2019 for the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. This manual establishes the policies and instructions related to laboratory quality assurance in cfsan. Interpretation of the good laboratory practice glp regulation. Good laboratory practices advisories quality assurance the laboratory inspectiondata audit program monitors the regulated community, who periodically raise questions related to the interpretation of the good laboratory practices glp regulations. This includes scientists, quality professionals, regulatory affairs personnel, preclinical and clinical trials professions, and anyone who is looking for a basic refresher. Food and drug administration fda, environmental protection agency epa, and u. The eu has concluded mutual recognition agreements for glp with israel, japan, and switzerland. Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice glp regulations when carrying out safety tests on. Glp is a formal regulation that was created by the fda united states food and drug administration in 1978. The information on this page is current as of april 1 2019 for the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Dec 18, 2014 any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice glp regulations when carrying out safety tests on. Good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. This course will be of benefit to anyone who needs a foundational understanding of fda good laboratory practices. Do the glps apply to validation trials conducted to confirm the analytical.
Electronic code of federal regulations ecfr title 21. This manual describes the structure and procedure of the israel national good laboratory practice glp monitoring unit within the israel laboratory accreditation authority israc. Good laboratory practice glp university of warwick. Free fda good laboratory practice tutorial glp the. The principles of good laboratory practice of the organisation for economic cooperation and development. Good laboratory practice internal market, industry. Good laboratory practice glp covers the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. Good manufacturing practice gmp, good laboratory practice glp and good clinical practice gcp, are followed in the respective stages of the development and lifecycle of a drug product. The manual complies with the following oecd documents. Good laboratory practice glp describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the u. The information on this page is current as of april 1 2019. Scope this standard operating procedure sop applies to the staff and students of the pharmacy department to follow the good laboratory practice glp.
Enforcement response policy for the federal insecticide, fungicide, and rodenticide act good laboratory practices glp regulations pdf 20 pp, 1 mb. Glps are very specific regulatory requirements for conducting the kinds of research listed below. The food and drug administration fda is proposing to amend the regulations for good laboratory practice glp for nonclinical laboratory studies to require a complete quality system approach, referred to as a glp quality system, when safety and toxicity studies support or are intended to. Glp, a data quality system, is not the same as standards for laboratory safety appropriate. Good laboratory practice regulations third edition, revised and expanded edited by sandy weinberg muhlenberg college allentown, pennsylvania, u. After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing chemicals and other test items with regard to their safety for humans and th. Revised guides for compliance monitoring procedures for good laboratory practice, environment.
Drug approval process good laboratory practices 6 automatic 30 day hold preclinical phase i phase ii phase iii. Good laboratory practice cfr code of federal regulations title. The requirements are clear, the guidelines and interpretations are available, and the conflicts are resolved. Glp good laboratory practice fda regulation, compliance. Applicable regulations good laboratory practices 5. Department of agriculture usda, as well as the organization for economic cooperation and development oecd international. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice. What are the main requirements of glp good laboratory. Interpretation of the good laboratory practice glp regulations. Read more on glp on the oecd good laboratory practice webpage. Daids guidelines for good clinical laboratory practice. You may need a pdf reader to view some of the files on this page. Use the manufacturers product insert for the kit currently in use.
The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations. Even the revolutionary influences of computerization in the laboratory have been measured and considered, providing the good automated laboratory practices. Good laboratory practice compliance european medicines. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. An introduction to good laboratory practices melissa elliott, bs, rqapglp. Fdas glp regulations, nonclinical laboratories will still. Background establishment of an effective quality assurance programme is one of the fundamental requirements if a test facility is to comply with the principles of glp. Food and drugs administration fda list of fda inspections of facilities that perform nonclinical laboratory studies. Its a great introduction and primer on the fdas glps good laboratory practice. This part prescribes good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the epa.
Glp helps to ensure the credibility and traceability of data submitted, thereby addressing the issue of. Oecd series on principles of good laboratory practice glp. Directive 200410ec of the european parliament and of the council of 11 february 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. The glp regulations have reached this next stage of evolved understanding. References in this part to regulatory sections of the code of federal regulations are to chapter i of title 21, unless otherwise noted. Oecd principles of good laboratory practice title oecd principles of good laboratory practice legislative basis directive 8718eec, directive 88320eec previous titles other references notes this annex is an extract from a decision of the council concerning mutual acceptance of data in the assessment of chemicals.
Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice glp, mutual acceptance of data mad. The document does not duplicate questions and answers that were dealt with in the august, 1979 post conference report on the good laboratory practice regulations management briefings. Daids guidelines for good clinical laboratory practice standards effective date. Good laboratory practice glp in the european union and other parts of the world it is a regulatory requirement that studies undertaken to demonstrate the health or environmental safety of new chemicals or biological substances should be conducted in compliance with the principles of good laboratory practice glp. The pertinent regulations in the preclinical scenario are the good laboratory practice. Good laboratory practice glp for safety tests on chemicals. Utilization of cdc recommendations for good laboratory.
In the experimental nonclinical research arena, good laboratory practice or glp is a quality. Ordinance on good laboratory practice oglp of 18 may 2005 status as of 1 december 2012 the federal council based on article 5 paragraph 2 letter a of the chemicals act of 15 december 2000 chema1, article 26 paragraph 3, article 38 paragraph 3 and article 39 paragraph 1 of the environmental protection act of 7 october 19832 epa. Investigations by these agencies in the mid1970s revealed that some studies had not been conducted in accordance with commonly accepted laboratory practices. A main objective is to provide a central resource for understanding the organizations. Good laboratory practice the why and the how springerlink. Laboratory safety guidance occupational safety and. The european regulations and directives also apply to iceland, liechtenstein, and norway. Glp is a formal regulation that was created by the fda united states food and drug administration in.
Daids guidelines for good clinical laboratory practice standards. The indispensable guide to good laboratory practice glp epub. It is intended to promote the quality and validity of test data and improve the international acceptance of data generated in adherence to its principles. These regulations contain the legislative measures necessary for the implementation within the united kingdom of council directive 8718eec on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, as amended by commission. An introduction to good laboratory practices glp life. The comments noted that unless epa amends its good laboratory practice standards to conform them to. Good laboratory practice glp shall play an important role in ensuring, consistency, reliability, reproducibility and quality of laboratory tests. Good laboratory practice glp is a quality system concerned with the organisational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Scientific measurements whether they pertain to monitoring contaminants in pharmaceutical products, clinical determinations of blood sugar, characterization of forensic evidence, or testing materials for space missions are generally recognized as affecting decisions literally concerned with life and death issues. Worker guidance in the form of fact sheets and quickcards is also provided for certain hazards. To assess awareness and use of the recommendations in the mmwr document by the key intended audience laboratory. Quality assurance in analytical chemistry training and teaching 2nd ed. Part 58good laboratory practice for nonclinical laboratory studies section contents subpart ageneral provisions. Code of federal regulations national toxicology program.
This content applies to human and veterinary medicines. Good laboratory practice guidelines cabrillo college. Good laboratory practices standards compliance monitoring. Glp is part of the quality assurance that ensures that organizations consistently produce and control goods to a high quality standard. Good laboratory practice glp regulations and guidelines. Free fda glp tutorial check out this fantastic free tutorial by the folks at labcompliance, good laboratory practice regulations. Market authorisation regulations require that quality standards, i. Good laboratory practices 1 keep the manufacturers product insert for the laboratory test in use and be sure it is available to the testing personnel. Do the glps apply to validation trials conducted to. Functions of the institutional animal care and use committee iacuc in a good laboratory practice glp animal testing facility are discussed. Fda regulations 21 cfr part 58 good laboratory practice for nonclinical laboratory studies describes requirements for conducting and reporting nonclinical laboratory studies compliance program guidance manual good laboratory practice program 7348.
The purpose of this regulatory directive is to inform applicants and other interested groups about the pest management regulatory agencys regulatory position on implementing good laboratory practice glp requirements for the preregistration testing of pest control products. Good laboratory practice for nonclinical laboratory studies. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of glp. In the experimental nonclinical research arena, good laboratory practice or glp is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical including pharmaceuticals nonclinical safety tests. This is different from laboratory safety standards such as appropriate clothing. Laboratory practice recommendations for biochemical genetic testing and newborn screening for inherited metabolic disorders as a morbidity and mortality weekly report mmwr recommendations and reports publication 1.
The good laboratory practice monitoring authority 4. This part is intended to assure the quality and integrity of data submitted pursuant to sections 3, 4, 5, 8, 18 and 24c of the federal. Good laboratory practice glp is a set of principles that guides how laboratory studies are planned, performed, monitored, recorded, reported and archived. Glp is sometimes confused with the standards of laboratory safety like. Dec 09, 20 good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Epas good laboratory practice standards glps compliance monitoring program ensures the quality and integrity of test data submitted to the agency in support of a pesticide product registration under the federal insecticide, fungicide and rodenticide act fifra, section 5 of the toxic substances control act tsca, and pursuant to testing consent agreements and test rules issued under. Glp embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived. Good laboratory practice regulations,third edition free. Please see this page for information about rqa during the covid19 pandemic, including updates and a free webinar. In 1981 an organization named oecdorganization for economic cooperation and development produced glp. Interpretation of the good laboratory practice glp. The principles of good laboratory practice glp define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. Glp regulations and united states department of agriculture regulations govern the handling of animals in research and testing. Nonclinical laboratory studies that support or are meant to support applications for research, or marketing permits for products regulated by the fda, including food and color additives, animal feed additives, human and animal drugs, medical devices for human use, biological products, and.
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