Good laboratory safety practice minimize all chemical exposures. 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. A documented procedural safety manual must be available for all staff, and its requirements followed. Good microbiological laboratory practice introduction industries in the durban area, have in their employ, manufacturing floor staff and general assistants with years of related experience but no formal qualification in microbiology or theoretical knowledge to support this practical experience. The content of the book has been developed in such a way that its text and content can adapt to the needs of various undergraduate microbiology courses. This manual should include laboratory spill and emergency procedures. 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. Sop on good laboratory practices glp pharmaceutical guidance. Guidelines for environmental control in healthcare facilities. The use of aseptic techniques and other good microbiological practices achieves two very important objectives.
Who good practices for pharmaceutical quality control. Clean laboratory work surfaces with an approved disinfectant after working with infectious materials. Introduction in the early 70 s fda united states food and drug administration have realized cases of poor laboratory practice throughout the united states. The document is a critical factor of the good laboratory practice documentation is the accepted method of recording information for future reference. Pdf good microbiology laboratory practice lasinrang. The reason why this book is so much popular among the medical students is that of. In 1981 an organization named oecdorganization for economic cooperation and development produced glp. The containment laboratory must not be cluttered in order to permit proper floor and work area disinfection.
Microbiological best laboratory practices, usp laboratory practices in microbiology. The major documents that need to be provided are protocols, logbook for usage, maintenance and calibration of equipment there should be well established sops. Also see the current version of usp, which provides some guidance on. If the test is stable for less than 24 hours or some change has occurred which could potentially affect the test stability, controls should be assayed more frequently. 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. Lab coats much be taken off when exiting the lab and entering a nonlaboratory area. Good laboratory practice when performing molecular amplification assays issue no. Standards unit, department for evaluations, standards and training page no. Daids guidelines for good clinical laboratory practice standards effective date. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of glp. The translation of the original document who good practices for pharmaceutical quality control laboratories 44th report annex 1 of who technical reports series, no. Using and benchmarking best laboratory practices plus good documentation practices ensures reliability of data. Good laboratory practices for molecular genetic testing for.
A laboratory manual is a musthave microbiology guide for the modern laboratory practice today. Environmental protection agency epa discussion forum. Dec 24, 2015 good laboratory practice article pdf available in journal of evolution of medical and dental sciences 4103. The principles of good laboratory practice of the organisation for economic cooperation and development. Good laboratory practice glp regulations and guidelines.
Good laboratory practice training manual for the trainer. Good microbiological laboratory practice durban university. Well, they are a way of developing control or, in analytical terms, having a system suitability of the laboratory. 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 isin akyar acibadem university faculty of medicine department of medical microbiology turkey 1. It should be remembered that many of the bacteria that are cultured in microbiological laboratories are capable of producing disease in humans. Good laboratory practice is demonstrated by the following example. Basic practical microbiology why microbiology matters. Perform all procedures to minimize splashes, spills and generation of aerosols. Good manufacturing practice gmp is a process that ensures that products that are produced by pharmaceutical companies are of quality standards. Microbiological best laboratory practices, usp value. An introduction to microbiology, aseptic technique and safety preparation safety guidelines 1 risk assessment 2 good microbiological laboratory practice gmlp 3 spillage management 3 aerosols 3 resources equipment 4 apparatus 5 materials 5 media, sterilisation and disinfection preparation of culture media 6 pouring a plate 6 storage of media 6. 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.
Free good laboratory practice online courses astra nova. Pdf good practices for pharmaceutical microbiology laboratories. Annex 2 who good practices for pharmaceutical microbiology. Good laboratory practice glp is a method employed in a laboratory setting to. Do the glps apply to validation trials conducted to. Good laboratory practice glp or good laboratory practices glps are accepted methods used in industries or hospitals and even laboratories to carry out activities or operations in a laboratory in order to achieve the desired or expected results. The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations. Nov 12, 2016 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. 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.
The recommended laboratory practices provide guidelines for ensuring the quality of the testing process including the preanalytic, analytic, and postanalytic phases of. A nucleic acid amplification test is used to detect chlamydia trachomatis in clinical samples. Glp is a formal regulation that was created by the fda united states food and drug administration in 1978. Good laboratory practices an overview sciencedirect topics. Glp help to ensure safety at every stage of the production process or experimentation. Cdcnih biosafety in microbiological and biomedical laboratories bmbl recommends that laboratory workers protect their street clothing from contamination by. Microbicepted methods and adherence to good laboratory ological sampling of surfaces.
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 take medication in the laboratory. It is therefore essential that good microbiology laboratory practice is observed at all times when working with any microbes. List of fda inspections of facilities that perform nonclinical laboratory studies. Daids guidelines for good clinical laboratory practice.
What is the importance of good laboratory practice. This nucleic acid amplification assay uses probes to hybridize to. The term good laboratory practice or glp was first introduced in 1970s in denmark and new zealand. Perform all procedures to minimize splashes, spills and generation of. Dec 27, 2016 the term good laboratory practice or glp was first introduced in 1970s in denmark and new zealand.
Pharmaceutical microbiology laboratories may be involved in. Good laboratory practices for pharmaceutical quality control. The three main elements of safe containment of microorganisms are 1 good laboratory practices and technique, 2 safety equipment, and 3 facility design. This course is useful for those who work in a glp regulated environment and have the responsibility to track and guarantee compliance. Lab coats much be taken off when exiting the lab and entering a non laboratory area. Microbiological best laboratory practices, usp the microbiology. Good laboratory practice in diagnostic laboratories using.
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. Implementation of good laboratory practices is very important in microbiology area because a lot of issues are found in microbiology during the regulatory audits. Do the glps apply to validation trials conducted to confirm the analytical. Glp is a formal regulation that was created by the fda united states food and drug administration in. 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. It is essential that crosscontamination of microbial cultures be minimized to. The prevention of contamination of the laboratory by the organisms. The techniques and activities described on the website and the microorganisms suggested present minimum risk given good practice. What are best laboratory practices in microbiology. Safety information good microbiological laboratory practice. Good microbiological practice gmp university of bristol. An introduction to microbiology, aseptic technique and safety. Never allow contaminated, infectious waste materials to leave the laboratory or to be put in the sanitary sewer without.