What are the main requirements of glp good laboratory practice. 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. 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. What is the importance of good laboratory practice. Good clinical practice definition of good clinical.
This is the second version of the who handbook on glp. Part 58, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction. Good laboratory practice an overview sciencedirect topics. Sop on good laboratory practices glp pharmaceutical. Generally accepted methods to perform an activity or operation in a lab.
Revised good laboratory practice regulations, final rule was published in the federal register on september 4, 1987. Glp an internationally recognized definition of glp. They also have a positive influence on the quality of the result. Glp is sometimes confused with the standards of laboratory safety like wearing safety goggles. 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. Good laboratory practice glp embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. Introduction to good clinical laboratory practice global. Good laboratory practice or good laboratory practices are accepted methods to carry out activities or operations in a laboratory. Do the glps apply to validation trials conducted to confirm the analytical.
Good clinical laboratory practices gclp should be used by all laboratories where tests are done on biological specimens for diagnosis, patient care, disease control and research. Good laboratory practice glp is a formal legally defined term that encapsulates the practice of using a standardized set of guidelines to generate reproducible. Daids guidelines for good clinical laboratory practice standards effective date. The entire sixth section of the chemicals act is devoted to good laboratory practice.
The principles have been developed in accordance with the organisation for economic cooperation and development oecd and the eu has adopted these principles and the revised oecd. Glp is a formal regulation that was created by the fda united states food and drug administration in 1978. Glp embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived. Definition of glp glp embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and. Good laboratory practices standards compliance monitoring. An internationally recognized definition of glp can be found on the website for the medicines and healthcare products regulatory agencyuk which defines glp as. Good laboratory practice is defined in the oecd principles as a quality system concerned with the organisational process and the conditions. The oecd principles of good laboratory practice glp ensure the generation of high quality and reliable test data related to the safety of industrial chemical. Dec 27, 2016 the term good laboratory practice or glp was first introduced in 1970s in denmark and new zealand. Thus, glp prescribes a laboratory to work according to a system of procedures and protocols. The principles of good laboratory practice glp promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices.
Good laboratory practice compliance european medicines agency. Good laboratory practice is defined in the oecd principles as a quality. Good laboratory practices glps, office of research, uga. The galp was developed to establish guidelines for automated data management in laboratories that supply. Sop on good laboratory practices glp pharmaceutical guidance.
If you make a writing error, dont scribble it out but draw a line through it make the correction and intial and date near the correction. Good laboratory practice compliance this content applies to human and veterinary medicines. Good automated laboratory practices galp is a standardized set of best practice s that are used to ensure data integrity for laboratory data that is gathered, processed, and archived by a laboratory information management system lims. We propose modifications to the definition of a testing facility to be applicable to all nonclinical laboratory studies, whether. These practices are known or believed to be safe and having a positive influence on the quality of the result, and are usually. 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. The good laboratory practice standards glps are federal regulations promulgated in the united states by both the food and drug administration in 21 cfr part 58 and the environmental protection agency both for fifra in 40 cfr part 160 and for tsca in 40 cfr part 792. Significant changes in the provisions with respect to quality assurance, protocol preparation, test and control article characterization, and retention of specimens and samples. To lay down a procedure for operation of hot plate. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Environmental protection agency epa discussion forum.
Daids guidelines for good clinical laboratory practice standards. In the experimental nonclinical research arena, good laboratory practice or glp is a quality. Soon after that, it was used by the federal drug administration fda and the organisation for economic cooperation and development oecd, referring to a quality system of regulation and management practices or requirements in research laboratories. In japan, the ministry for agriculture, forestry and fisheries maff has also adapted a version of the glps. Good laboratory practice for nonclinical laboratory studies. A term of art used in clinical trials for the standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial. Good operating practice is a strategic management term. Apr 01, 2019 the information on this page is current as of april 1 2019. This content applies to human and veterinary medicines. 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. Good laboratory practice glp embodies a set of principles that provides a framework. More specific uses of the term include good agricultural practices, good manufacturing practice, good laboratory practice, good clinical practice and good distribution practice.
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. List of fda inspections of facilities that perform nonclinical laboratory studies. These reasons explain why government agencies worldwide require glp compliance, and why it is entirely appropriate for greater. Introduction to good clinical laboratory practice is a standalone short course for all those wanting to gain an understanding of gclp and its application in laboratories. The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations. Good laboratory practice for nonclinical laboratory studies fda. Good laboratory practice or glp is a set of principles intended to assure. This is the definition of good laboratory practice in the oecd principles of good laboratory practice which were then transposed into ec directives and, after that, into german law as annex 1 of the german chemicals act. This editorial is not meant to discuss anything new but to emphasize the well accepted guidelines for gclp.
The term good laboratory practice or glp was first introduced in 1970s in denmark and new zealand. Good laboratory practice glp is concerned with the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. Good laboratory practice compliance european medicines. The principles of good laboratory practice of the organisation for economic cooperation and development. Good laboratory practice glp for safety tests on chemicals. In many instances, the optimal recommended noargument means of implementing glp is to develop an automated approach to both sample. Good laboratory practice glp the oecd principles of good laboratory practice glp ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. Good laboratory practices an overview sciencedirect topics. What are the main requirements of glp good laboratory. These practices are known or believed to be safe and having a positive influence on the quality of the result, and are usually independent of the test or measurement techniques employed. Glp good laboratory practices good laboratory practice or glp specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical including pharmaceuticals non clinical safety tests. Do the glps apply to validation trials conducted to.
Good laboratory practice for nonclinical laboratory. Aug 25, 2010 good clinical laboratory practices gclp should be used by all laboratories where tests are done on biological specimens for diagnosis, patient care, disease control and research. 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 information on this page is current as of april 1 2019. Laboratory practice of the organisation for economic cooperation and development oecd form the basis of this series of guidance documents. 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. 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. The principles of glp define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating. The term glp is most commonly associated with the pharmaceutical industry and the required nonclinical. Youre the newest member of the quality assurance department at catt the center for the advancement of toast technology. Glp means the current standards for laboratory activities for pharmaceuticals, as set forth in the fdas good laboratory practice regulations or the good laboratory practice principles of the organization for economic cooperation and development, as amended from time to time, and such standards of good laboratory practice as are required by the mhlw and.
Daids guidelines for good clinical laboratory practice. Good laboratory practice glp requirements, based on these fundamental scientific principles and practices, are indispensable for providing scientific confidence in studies conducted for chemical safety determinations. As used in this part, the following terms shall have the meanings specified. The need for a hybrid of good laboratory practice and good clinical practice guidelinesstandards for medical testing laboratories conducting clinical trials in developing countries. Good laboratory practices or glp means, with respect to the united states, the thencurrent requirements for nonclinical animal or laboratory studies that will be submitted to a government authority to support a marketing application, specified in 21 c. Our proposed definition is consistent with the definition of vehicle in the oecd glp document, oecd principles on good laboratory practice ref. 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 glp is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. 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 glp regulations and guidelines. 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. The authorities and laboratory organizations say that these practices help ensure safety. Glp regulations require clear definitions of the structure of the.
This standard operating procedure is applicable to quality control department followed at pharmaceutical company name with location. Your mission is to audit the company and determine if its sops, notebooks, equipment, personnel, reagent labels, and test animals are glp compliant. Good laboratory practice or legal definition of good. Qc personnel shall be responsible to follow the procedure as per sop. Subpart g protocol for and conduct of a nonclinical laboratory study 58. Good laboratory practice or glp refers to the accepted methods of carrying out activities or operations in a laboratory, i. The major documents that need to be provided are protocols, logbook for usage, maintenance and calibration of equipment there should be well established sops.
Good clinical practice definition of good clinical practice. By definition good laboratory practice embodies a set of principles that provide a framework within which laboratory studies are planned, performed, monitored. The definition of the term good laboratory practice itself, which identifies glp as a quality system related with the organisational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and. Good laboratory practice definition and meaning good laboratory practice or good laboratory practices are accepted methods to carry out activities or operations in a laboratory. Good laboratory practices legal definition of good. Raw data is defined as any laboratory worksheets, records, memorandum. Good laboratory practice internal market, industry. Good laboratory practices or glp means all applicable good laboratory practice standards, including, as applicable, a as set forth in the thencurrent good laboratory practice standards promulgated or endorsed by the fda as defined in 21 c.
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