The following selfassessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a clinical laboratory. Witnessing cont witness should sign and date any new ideas, plans, procedures, sketches, etc. Label and date everything and include your initials 2. Following are the main points those should be considered under glp. Documentation is best lab practices beyond the simple chemistry lab.
Microbiological best laboratory practices general information usp 35 glassware or from prior materials used in the glassware. Glps and the importance of standard operating procedures. 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. 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. Good laboratory practices for molecular genetics testing. It is a quality system which intends to ensure through careful and accurate documentation, covering all aspects of study and of its environment, the quality, integrity and reliability of safety data.
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. Jan 22, 2014 the good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. January 26, 2017 page 2 of 2 never eat, drink, store food or drinks and related utensils, apply cosmetics or lip balm, handle contact lenses or. Good laboratory practice compliance this content applies to human and veterinary medicines.
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. Wash your hands after removing gloves, before leaving the laboratory, and after handling a potentially hazardous material. 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. Glp is a formal regulation that was created by the fda united states food and drug administration in 1978. This part describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the. Data obtained through laboratory inspections and data audits is used by the agency to regulate the use of pesticides and industrial chemicals. They discovered a lot fraudulent activities and a lot of poor lab practices. The laboratory should be located designed, customized and maintained to. The performance of your pipette is key and is a result of several factors, which include ensuring desired. The good laboratory practices glps are extremely effec tive guidelines intended to provide management with a tool for controlling regulated laboratories and. Thermo scientific good laboratory pipetting glp practices. Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products. The principles of good laboratory practice glp define a set of rules and criteria for a quality system.
Complying with gclp is an ongoing process that is central. 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. Using the precisely manufactured pipette tips designed to work. Tdr developed a good laboratory practices glp series in 2001, comprising a glp handbook as well as glp training manuals for trainers. The performance of your pipette is key and is a result of several factors, which include ensuring desired specifications are met. Good laboratory practices an overview sciencedirect topics. State lab program resources lab metrology training laws and regulations expand or collapse. They also have a positive influence on the quality of the result. Environmental protection agency epa discussion forum.
In pharmaceutical laboratories, glp should be followed. Glp embodies a set of principles that provides a framework within which laboratory studies are planned. Good laboratory notebook practices ars laboratory notebooks are bound notebooks always use official ars laboratory notebook ars form 1 why notebooks are. Utilization of cdc recommendations for good laboratory. Be media should be labeled properly with batch or lot numsure. Good laboratory practice training manual for the trainer. Daids has determined that good clinical laboratory practices gclp are the minimal requirements that clinical research laboratories should follow, as gclp embraces both the researchpreclinical and clinical aspects of good laboratory practices glp. While working in the laboratory, wear personal protective equipment eye protection, gloves, laboratory coat as directed by your supervisor.
At the same time the term good laboratory practice has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work. Good laboratory practices standard operating procedures standard operating procedures sops are developed by epa as guidance for inspectors done under the good laboratory practices glps program as set forth in the federal insecticide, rodenticide and fungicide act and the toxic substances control act. Infrastructure and accommodation and related requirement 7 4. Ppt good laboratory practices powerpoint presentation. 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. Good laboratory pipetting practices significantly influence the results of your liquid handling. Good laboratory practice or good laboratory practices are accepted methods to carry out activities or operations in a laboratory. Describe the scope of testing normally applicable for a food laboratory 3 2. Do the glps apply to validation trials conducted to confirm the analytical. Glp good laboratory practices good laboratory practice or glp specifically refers to a quality system of management. Dec 24, 2015 good laboratory practice article pdf available in journal of evolution of medical and dental sciences 4103. List of fda inspections of facilities that perform nonclinical laboratory studies. Enforcement response policy erp for the federal insecticide, fungicide, and rodenticide act fifra good laboratory practices glp regulations. To good laboratories, these best practices become routine procedures.
Good laboratory practices good measurement practices. Beyond the simple chemistry lab directions of dont taste the chemicals. 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. Documentation is best lab practices beyond the simple chemistry lab directions of dont.
For decisions of safety, there must be rigorous and thorough application of fundamental scientific practices, irrespective of the purpose of the study and where it is conductedacademic, industry, or a contract laboratory. Daids has determined that good clinical laboratory practices gclp are the minimal requirements that clinical research laboratories should follow, as gclp embraces both the researchpreclinical and. Although some of the recommendations in this training exceed clia and other requirements that pertain to molecular genetic testing, following these good laboratory practices will likely lead to improvements in the quality and use of genetic laboratory services and improved health outcomes for the public. In the experimental nonclinical research arena, good laboratory practice or glp is a quality. It is a quality system which intends to ensure through careful and accurate. These issues are probably caused, in p art, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training.
Glp refers to a quality systems of management controls for laboratories and research organizations to ensure the consistency and reliability and reproducibility of. Good laboratory practice compliance european medicines agency. Two epa enforcement policies address the glps program. Good laboratory practice presented to presented by dr. The good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976.
Daids guidelines for good clinical laboratory practice standards. In the early 70s fda became aware of cases of poor laboratory practice all over the united states. Microbiological best laboratory practices, usp standard operating procedures standard operating procedures sops are developed by epa as guidance for inspectors done under the good laboratory practices glps. Good food laboratory practices gflps 2 good food laboratory practices gflps table of contents s. A good practice guide to the administration of substances. This document complements the job descriptions, procedure sheets, the registry of accidents, incidents and specifications security data sheets. 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 demand for this series was so substantial that it. Good laboratory practice internal market, industry. Environment conditions, safety and related requirements 12. 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. A good practice guide to the administration of substances and removal of blood, including routes and volumes karlheinz diehl1, robin hull2, david morton3, rudolf p. Pdf in the present era of rapidly evolving technology and evidence based medicine, good laboratory practice glp shall play an important role in. Quality assurance in analytical chemistry training and teaching 2nd ed. The demand for this series was so substantial that it became one of the most frequent hits on the tdr website, generating interest and demand for a second edition. Good laboratory practices standards compliance monitoring. Good laboratory practices standard operating procedures. The authorities and laboratory organizations say that these practices help. Good laboratory practice glp regulations and guidelines. Good laboratory practice compliance european medicines.
Do the glps apply to validation trials conducted to confirm the. By january 1986, scientists at searle had developed a document, good laboratory practice, which was designed to be used as guidance to evaluate research activities, and submitted it. The principles of good laboratory practice glp promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices. Daids guidelines for good clinical laboratory practice. Good laboratory practice training manual for the trainee. The authorities and laboratory organizations say that these practices help ensure safety. The purpose of these principles of good laboratory practice is to promote the development of quality test data. The original regulatory enforcement was first published by fda and then a few years later by epa. Although some of the recommendations in this training exceed clia and other requirements that pertain to molecular genetic testing, following these good laboratory practices will likely lead to improvements.