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. Limited, alexandria knowledge park, genome valley, hyderabad. The good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. Seperti yang kita ketahui glp adalah salah satu sistem manajemen pengelolahan laboratorium yang mencakup secara keseluruhan aspek teknis dan manajemen, yaitu meliputi organisasi, fasilitas, tenaga, metode analisa. Good laboratory practices standard operating procedures. Gmp merupakan prasyarat utama sebelum suatu industri pangan dapat memperoleh sertifikat sistem haccp hazard analysis critical control point 1. I will follow good laboratory practice, including returning materials to their correct locations, proper care and handling of equipment. The objective of this procedure to avoid the errors inherent in the performance of any analysis, good laboratory practices shall be followed. Secara garis besarnya, prinsip berlaboratorium yang baik dicirikan dengan. The 1997 revision of the oecd principles of good laboratory practice has provided the reason to write this book and to present my views on glp, to.
Guru mampu menerapkan good laboratory practice glp. Good laboratory safety practices kansas state university. Compliance with the principles of good laboratory practice glp is a regulatory requirement for test facilities that undertake health and environmental safety studies, and some other testing, that will be submitted to regulatory authorities for the purpose of risk assessment. 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. How can good laboratory practice be introduced in a test facility. 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. In 1981 an organization named oecdorganization for economic cooperation and development produced glp. Glp good laboratory practice guidelines in academic and. A free powerpoint ppt presentation displayed as a flash slide show on id. The principles of good laboratory practice of the organisation for economic cooperation and development. 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.
Use the manufacturers product insert for the kit currently in use. Istilah tersebut dapat mempunyai arti lain dalam konteks lain. I will always use a lab coat inside the laboratory. The good laboratory practices glps are extremely effec tive guidelines intended to provide management with a tool for controlling regulated laboratories and. Reichmuth1 1 federal biological research centre for agriculture and forestry bba, institute for stored product protection. Introduction of good laboratory practice zhou chen, md, phd division of new drug bioequivalence evaluation office of study integrity and surveillance office of translational sciences center for drug evaluation and research us food and drug administration. This editorial is not meant to discuss anything new but to emphasize the well accepted guidelines for gclp. It is a managerial concept covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported oecd glp guideline. Daids guidelines for good clinical laboratory practice. 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. Definisi di bawah ini dipakai sebagai istilah yang digunakan dalam pedoman ini. Penanganan contoh yang akan diuji dan barang yang akan dikalibrasi. 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.
For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Pdf pengertian dan jenis glp good laboratory practice. Quality assurance in analytical chemistry training and teaching 2nd ed. Oecd principles of good laboratory practice shall be accepted in.
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. 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 practice glp chance and impediment for. Training glp good laboratory practices 2020 murah dan.
This sop is to provide guidelines for good laboratory practice. Good laboratory practice glp is intended to promote the quality and validity of test data. Good laboratory practice glp chance and impediment for the registration of new fumigants phosphine residues as an example d. Good microbiological laboratory practices gmlp post a department emergency information sign at the laboratory entrance. Glp embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived. Good laboratory practices for molecular genetic testing. Ppt good laboratory practices powerpoint presentation.
In the present era of rapidly evolving technology and evidence based medicine, good laboratory practice glp shall play an important role in ensuring, consistency, reliability, reproducibility. Metode prosedur pengujian memiliki arti sangat penting dalam melaksanakan kegiatan pengujian. Include the name and contact information of the laboratory supervisor or other responsible person. 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. Glp is a formal regulation that was created by the fda. Standard operating procedure of good laboratory practice to avoid the errors inherent during performance of any analysis. The recommended laboratory practices provide guidelines for ensuring the quality of the testing process including the preanalytic, analytic, and postanalytic phases of. Your laboratory instructor will be evaluating your experimental. 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. Daids guidelines for good clinical laboratory practice standards effective date. Pengertian good laboratory practice atau glp adalah suatu cara pengorganisasian laboratorium dalam proses pelaksanaan pengujian. 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.
What is the importance of good laboratory practice. Makalah manajemen laboratorium pengertian dan jenis glp good laboratory practice disusun oleh. The information on this page is current as of april 1 2019. How is compliance with good laboratory practice monitored. 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 regulationscfr as 21 cfr part 58 in 1979. 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 universitas pgri semarang. Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products. Pengertian jaminan mutu dan pengendaian mutu laboratorium lingkungan data hasil pengujian dapat dinyatakan memenuhi sasaran mutu data data quality objective, dqo, jika data pengujian tersebut dapat memuaskan pelanggan dengan tetap mempertimbangkan aspek teknis, sehingga akurasi dan presisi memenuhi batas keberterimaan. The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations.
Tdr developed a good laboratory practices glp series in 2001, comprising a glp handbook as well as glp training manuals for trainers and trainees. 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. Pengertian jaminan mutu dan pengendaian mutu laboratorium. I will use protective glasses when i am working with acids, bases and other corrosive chemicals. Air harus berkualitas air minum, fasilitas perorangan dan kamar mandi.
After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing. 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. It is assumed that the student is familiar with and always practices the following procedures outlined in this section. Pdf pengertian dan jenis glp good laboratory practice elga. Good manufacturing practices cara pengolahan pangan yang baik gmp good manufacturing practices merupakan suatu pedoman bagi industri pangan, bagaimana cara berproduksi pangan yang baik. Implementation of good laboratory practice in a university research unit. Introduction to good laboratory practices glps the following notes on proper experimental technique and use of equipment are collectively known as glps. This third edition of good laboratory practice regulations reflects that evolutionary maturity of requirements. Training good laboratory practices oleh bmd street consulting membantu untuk kompetensi penanganan dan pengelolahan laboratorium sesuai dengan standar glp.
Makalah glp good laboratory practice yons collection. In accord with agency procedures, responses have been prepared. Makalah tentang pengertian dan jenis glp manajemen laboratorium. With a relative uniformity of interpretation more specific and applied information can be provided, furnishing the reader with both the theoretical overview necessary to an.
Good laboratory safety practice pel permissible exposure limit osha tlv threshold limit value acgih pels vs. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of glp. This manual establishes the policies and instructions related to laboratory quality assurance in cfsan. Good laboratory practice training manual for the trainer. Glp is sometimes confused with the standards of laboratory safety like wearing safety goggles. A main objective is to provide a central resource for understanding the organizations. 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. The term good laboratory practice or glp was first introduced in 1970s in denmark and new zealand.
662 123 285 157 314 480 182 742 894 266 1191 900 1372 413 1215 214 203 205 364 1369 1363 453 536 503 649 156 1153 1421 49 238 1495 1502 1109 1362 122 414 395 395 800 684 1120 1487 514