Do the glps apply to validation trials conducted to confirm the analytical. Dec 24, 2015 good laboratory practice article pdf available in journal of evolution of medical and dental sciences 4103. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of glp. In chapter 4 the glps are applied to an automated laboratory as the epa good automated laboratory practices. Good agricultural practices are born in this context and can be simply defined as doing things well and guaranteeing it has been done so gaps and gmps good manufacturing practices are a set of principles, regulations and technical recommendations applicable to production, processing and food transport, addressing human health care. Good laboratory practices standard operating procedures.
Penelitian ini bertujuan untuk menganalisis penerapan good laboratory practice glp di laboratorium program studi pendidikan teknologi agroindustri ptag. Good laboratory practice atau glp adalah suatu cara pengorganisasian laboratorium dalam proses pelaksanaan pengujian, fasilitas, tenaga kerja dan kondisi yang dapat menjamin agar pengujian dapat dilaksanakan, dimonitor, dicatat dan dilaporkan sesuai standar nasionalinternasional serta memenuhi persyaratan keselamatan dan kesehatan. 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. 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. Definisi good laboratory practices adalah aturanaturan, prosedurprosedur dan praktek di laboratorium yang cukup untuk menjamin mutu dan intensistas data analitik yang dikeluarkan oleh laboratorium tersebut. Following are the main points those should be considered under glp. Limited, alexandria knowledge park, genome valley, hyderabad. For laboratories and test organizations that are considering applying for. Nov 19, 2015 good laboratory practice glp adalah keterpaduan suatu proses organisasi, fasilitas, personel dan kondisi lingkungan laboratorium yang benar sehingga menjamin pengujian di laboratorium selalu direncanakan, dilaksanakan, dimonitor, direkam, dan dilaporkan sesuai dengan persyaratan kesehatan dan keselamatan serta perdagangan. Gone are the days when the glp regulations were hotly debated amongst scientists in. Setelah kita melihat, membaca, menganalisa data diatas dan membandingkan gambaran laboratorium puskesmas pandean dengan literatur good laboratory practice glp maka dapat di ambil kesimpulan bahwa laboratorium puskesmas pandean belum memenuhi syarat good laboratorypractice glp kementerian kesehatan republik indonesia. Sedang ssop merupakan prosedur yang digunakan oleh industri untuk membantu mencapai tujuan atau sasaran keseluruhan yang diharapkan gmp dalam memproduksi pangan yang bermutu tinggi aman dan tertib. This editorial is not meant to discuss anything new but to emphasize the well accepted guidelines for gclp. The objective of this procedure to avoid the errors inherent in the performance of any analysis, good laboratory practices shall be followed.
The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations. 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 practices glps 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. 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. Peraturan ini bertujuan untuk mengaturcara penyelenggaraan laboratorium klinik yang baiksehingga dapat memberikan pelayanan dan hasil yang bermutu serta dapat dipertanggungjawabkan. Daids guidelines for good clinical laboratory practice standards. 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.
Laboratory practice glp were finalized and led to the oecd council decision on the mutual acceptance of data mad which states that data generated in the testing of chemicals in an oecd member country in accordance with oecd test guidelines and oecd principles of good laboratory practice shall be accepted in other member. Free good laboratory practices glp is linked to a quality system that controls how nonclinical safety studies are planned, conducted, monitored, recorded, reported, documented and archived. Good laboratory practice glp for safety tests on chemicals. Good laboratory practices for molecular genetic testing for.
Definisi good laboratory practices adalah aturanaturan, prosedurprosedur dan praktek di laboratorium yang cukup untuk menjamin mutu dan intensistas data analitik yang dikeluarkan oleh. Pengertian good laboratory practice atau glp adalah suatu cara pengorganisasian laboratorium dalam proses pelaksanaan pengujian, fasilitas, tenaga kerja dan kondisi yang dapat menjamin agar pengujian dapat dilaksanakan, dimonitor, dicatat dan dilaporkan sesuai standar nasionalinternasional serta memenuhi persyaratan keselamatan dan kesehatan. Good laboratory practice glp dibutuhkan untuk meningkatkan kualitas dan integritas kerja di laboratorium. Daids guidelines for good clinical laboratory practice. Gmp secara luas terfokus dan pada aspek operasi pelaksanaan tugas dalam pabriknya sendiri serta operasi personel. Glp is part of the quality assurance that ensures that organizations consistently produce and control goods to a high quality standard. You may need a pdf reader to view some of the files on this page. Chapters 4 and 5 focus on two important applications of the glps. Penerapan glp ditinjau dari 8 indikator meliputi indikator organisasi, personel, fasilitas, penanganan bahansampel, metode. Bekerja di laboratorium memerlukan keterampilan yang baik good laboratory practice glp, dimana glp adalah suatu cara pengelolaan laboratorium secara keseluruhan agar laboratorium sebagai data generator dapat menghasilkan data yang dapat dipercaya kebenarannya dengan memenuhi persyaratan k3 keselamatan kesehatan kerja. Makalah glp good laboratory practice yons collection. Berawal dari kondisi inilah dirasakan perlunya penerapan cara laboratorium yang bail good laboratory practices glp. Standard operating procedure of good laboratory practice to avoid the errors inherent during performance of any analysis. Good laboratory practice training manual for the trainer.
This course is useful for those who work in a glp regulated environment and have the responsibility to track and guarantee compliance. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. 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. 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. Department of agriculture usda, as well as the organization for economic cooperation. The procedures established by the laboratory are designed to. Apr 01, 2019 a this part prescribes 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 food and drug administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic. Use the manufacturers product insert for the kit currently in use. Good laboratory practice is not only concerned with production, but also quality control. The principles of good laboratory practice of the organisation for economic cooperation and development. Good laboratory practices glps, office of research, uga. 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. The oecd principles of good laboratory practice oecd series on principles of good laboratory practice and compliance monitoring, number 1, envmcchem9817, or subsequent revisions are adopted as the glp standard by the pest management regulatory agency pmra.
Glp good laboratory practice guidelines in academic and. After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing. Good laboratory practice glp adalah keterpaduan suatu proses organisasi, fasilitas, personel dan kondisi lingkungan laboratorium yang benar sehingga menjamin pengujian di laboratorium selalu direncanakan, dilaksanakan, dimonitor, direkam, dan dilaporkan sesuai dengan persyaratan kesehatan dan keselamatan serta perdagangan. Guidelines on good laboratory practices for pharmaceutical quality control laboratories in lebanon 2016 edition 1 341 introduction the good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of. Risk group safety level laboratory type laboratory practices safety equipment 1 l1 research, teaching good laboratory practice fume hood 2 l2 reserch biomedical laboratory biohazard symbol, good laboratory practices, specific protection fume hoods and safety cabinets 3 l3 research, biomedical, immunology same as 2, restricted area. Pdf pengertian dan jenis glp good laboratory practice. Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products.
The information on this page is current as of april 1 2019. The dsst laboratory quality control lqc plan is intended to substantiate the validity of the data produced by their laboratories. Gmp good manufacturing practices cara pengolahan pangan. Guidelines on good laboratory practices for pharmaceutical quality control laboratories in lebanon 2016 edition 1 341 introduction the good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients apis. 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. The recommended laboratory practices provide guidelines for ensuring the quality of the testing process including the preanalytic, analytic, and postanalytic phases of. Good laboratory practices for pharmaceutical quality.
Food and drug administration fda, environmental protection agency epa, and u. Free good laboratory practice online courses astra nova. The purpose of this code of practice is to indicate the steps that should be taken in order to prevent or control exposure. Gone are the days when the glp regulations were hotly debated amongst scientists in academia and industry and were accused of. Menteri adalah menteri yang menyelenggarakan urusan pemerintahan di bidang kesehatan. Good laboratory practice glp describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the u. Glp good laboratory practice guidelines in academic and clinical research. 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. Good laboratory practices for molecular genetic testing. Good laboratory practices a set of rules, operating procedures and the proper practices that ensurer the reliability of the data generated by pharmaceutical control laboratories 3 principles, or parts, of good laboratory practices. Good laboratory practices for pharmaceutical quality control. In pharmaceutical laboratories, glp should be followed. In japan, the ministry for agriculture, forestry and fisheries maff has also adapted a version of the glps.