The following standard and special practices, safety equipment and facilities apply to agents assigned to biosafety level 1. Good laboratory practice isin akyar acibadem university faculty of medicine department of medical microbiology turkey 1. The use of aseptic techniques and other good microbiological practices achieves two very important objectives. Microbiological best laboratory practices, usp value and recent changes to a guidance of quality laboratory practice with don singer. The three main elements of safe containment of microorganisms are 1 good laboratory practices and technique, 2 safety equipment, and 3 facility design.
Fda decided to check over 40 toxicology labs indepth. Microbiological best laboratory practices, usp laboratory practitioner and significant operational capabilities of the laboratory itself. Even though implementing a quality system in a basic research. They are accompanied by a whotdr handbook on glp blue which includes an introduction to glp, texts concerning the salient points of the. Quality assurance unit qau comprised of the quality assurance officer qao, who serves as the quality manager for the laboratory and the alternate qao. Microbiology practical introduction lab, culture media, culture techniques duration. Good laboratory practices for pharmaceutical quality control. A2la american association for laboratory accreditation 2. Since june 20, 1979, the agency has been asked many questions on the good laboratory practice. It is the result of experience gained since the first version was published. Uk standards for microbiology investigations smis are developed under the auspices of public health england phe working in partnership with the national health service nhs, public health wales and.
The purpose of this manual is to provide teachers and technicians with good techniques. Microbiology lab safety university of minnesota duluth. Also see the current version of usp, which provides some guidance on. This presentation is compiled by drug regulations a non profit organization which provides free online resource to the pharmaceutical professional.
Good laboratory practices for pharmaceutical quality. Daids guidelines for good clinical laboratory practice standards. Good clinical laboratory practice gclp for molecular. The training is based on the organization for economic cooperation and development oecd glp principles which are recognized as the international standard for glp. To harmonize practices and generate mutually acceptable data for nonclinical health and environmental safety studies the organization for economic cooperation and development oecd evolved good laboratory practice glp guidelines. Good laboratory safety practice pel permissible exposure limit osha tlv threshold limit value acgih pels vs. Good laboratory notebook practices ars laboratory notebooks are bound notebooks always use official ars laboratory notebook. Wash your hands with disinfectant soap when you arrive at the lab. Jan 07, 2008 a set of good clinical laboratory practice gclp standards that embraces both the research and clinical aspects of glp were developed utilizing a variety of collected regulatory and guidance material. They have been designed for use as an introductory course to glp. Microbiology laboratory includes procedures and test methods. The principles of good laboratory practice of the organisation for economic cooperation and development oecd form the basis of this series of guidance documents. Laboratory notebooks can also be designated to logtrack specific lab tasks. Niaid division of aids guidelines for good clinical laboratory practice standards.
Annex 1 who good practices for pharmaceutical quality control. Pdf food microbiology download full pdf book download. Biosafety in microbiological and biomedical laboratories bmbl quickly became the cornerstone of biosafety practice and policy in the united states upon first publication in 1984. This is a scientific laboratory course, and thus a working medical office floor plans pdf understanding of the. Include the name and contact information of the laboratory supervisor or other responsible person. Good clinical laboratory practice gclp for molecular based tests used in diagnostic laboratories 33 depending on the nucleic basis of the test, rna versus dna, this will also impact on the time between. Annex 2 who good practices for pharmaceutical microbiology.
The purpose of this pharmaceutical microbiology manual pmm is to. Guidelines for best practice for microbiology in australian schools. Laboratory ethics policy example it shall be the policy of the xxxx laboratory to conduct all business with integrity and in an ethical manner. The laboratory notebook or test sheet will be used to record all raw data generated during gmp activities. The prevention of contamination of the laboratory by the organisms being handled the prevention of contamination of the work with organisms from the environment. The material is carefully targeted to meet curriculum requirements and fit in with the specifications for science. Epa good laboratory practices glp 40 cfr part 160 4. Also it can be a good reference book for those who come along. Good laboratory practice ainoon othman department of pathology faculty of medicine, ukm fundamental points of glp good laboratory practice applied in whatever. Good clinical laboratory practice gclp is a standard that ensures quality and reliability of research data by adopting the principles of good laboratory practice and good clinical practice. The society produces a wide range of microbiology teaching resources for all age groups from primary to post16. This manual has been written for a righthanded person. For quality control purposes, the required information is documented in the laboratory notebook or on the appropriate record forms see section 14. The opp microbiology laboratory conforms to 40 cfr part 160, good laboratory practice standards glp.
The usp informational chapter microbiology best laboratory practices. It is therefore necessary to strengthen the capacity of these countries to conduct research and drug product development studies at a level comparable to that in other parts of the world. Microbiological best laboratory practices, usp microbiology laboratory. Good laboratory practices for molecular genetic testing. Good laboratory practice glp and standard operating procedures sops provide guidelines for proper operation of equipment, maintenance and sanitation, reporting structures, and related activities. Basic practical microbiology why microbiology matters. Us environmental protection agency office of pesticide programs. Pharmaceutical microbiology laboratories may be involved in. Pdf good practices for pharmaceutical microbiology laboratories. Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing and postmarket activities for regulated pharmaceuticals, biologics, medical devices, etc.
In accord with agency procedures, responses have been prepared. 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. The good laboratory practice glp training manual comprise two documents. Access to the laboratory is limited or restricted at the discretion of. 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. As part of good laboratory practice, primary and working. Introduction in the early 70 s fda united states food and drug administration have realized cases of poor laboratory practice throughout the united states. Daids guidelines for good clinical laboratory practice standards effective date. D microbiology 7 introduction welcome to the microbiology laboratory. Microbiological best laboratory practices, usp value and recent changes to a guidance of quality laboratory practices microbiology mayjune 2011 1. Understanding the principles of good clinical laboratory.
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. Bsl4 requires changing from street clothesshoes to approved laboratory garments and footwear. The goal of the laboratory is to expose students to the wide variety of lives in the microbial world. The recommended laboratory practices provide guidelines for. Microbiological best laboratory practices, usp value. Glp is a formal regulation that was created by the fda united states food and drug administration in 1978.
Good microbiology laboratory practice ramasundaram srikumar. Asmscience establishing good laboratory practice at small. Center for disease controls cdc manual biosafety in microbiological. Guidelines for good clinical laboratory practice standards. Good clinical practices gcp guidelines in 2002 to guide biomedical research in the country. Overview of a medical microbiology laboratory duration. The oecd documents are provided as an annexe to this handbook.
This is the second version of the who handbook on glp. Ppt good laboratory practice powerpoint presentation. Implementation of good clinical laboratory practice in an. The pertinent regulations in the preclinical scenario are the good laboratory practice glp. Microbiological best laboratory practices, usp the microbiology. Barrier procedures against incoming microbiological contamination are.
This good laboratory practice glp handbook is designed to aid those wishing to upgrade their laboratories to. Laboratory b iosafety is primarily achieved through a basic level of operational practices that include good microbiological laboratory practices and physical design features of a functional well designed laboratory. It is imperative to have some basic knowledge, experience and infrastructure that can support consistent use of these methods. Good clinical laboratory practice gclp is a set of standards that provide guidance on implementing good laboratory practice glp and good clinical practice gcp principles to the analysis of samples from a clinical trial. Good microbiological practice version 1 organisms, including genetic modification work, irrespective of containment level and is a specific requirement of the genetically modified organisms contained use regulations. The principles of gmlp is a code of practice that should be applied to. Pdf good microbiology laboratory practice lasinrang. 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. These practices are routinely employed at large academic and researchbased institutions. Good practices for pharmaceutical microbiology laboratories. Good laboratory practice training manual for the trainer. Glp in microbiology laboratory ankur choudhary print question forum 1 comment good manufacturing practice gmp is a process that ensures that products that are produced by pharmaceutical companies are of quality standards.
The good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients apis, excipients and. It is a basic and expected responsibility of each staff member and each manager to hold to the highest ethical standard of professional conduct in the performance of all duties. The analyst requests a laboratory notebook or test sheet from the administrator if not supplied with the test sample. Tlvs pels and tlvs are airborne concentrations of chemicals set as limits, which are generally. Daids guidelines for good clinical laboratory practice.
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. 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. This presentation gives a summary of the who guidance on good practices for microbiology labs. Principles of laboratory food microbiology serves as a general laboratory guide for individuals in quality control, quality assurance, sanitation, and food production who need to increase their knowledge and skills in basic and applied food microbiology and food safety. Uk standards for microbiology investigations smis are developed under the auspices of public health england phe working in partnership with the national health service nhs, public health wales and with the professional organisations. Good microbiological laboratory practices gmlp post a department emergency information sign at the laboratory entrance. Food and drugs administration fda list of fda inspections of facilities that perform nonclinical laboratory studies. The purpose of this regulatory directive is to inform applicants and other interested groups about the pest management regulatory agencys regulatory position on implementing good laboratory practice glp requirements for the preregistration testing of pest control products. Appropriate quality control measures are integrated into each sop. Single copies of nonchargeable resources are free to anyone involved with teaching microbiology in the uk and ireland. Although the study of microbiology includes bacteria, viruses, algae and protozoa, this lab. Each instrument, device or apparatus used for analysis should be calibrated and verified while ensuring good laboratory practice in a pharmaceutical laboratory. Uk standards for microbiology investigations uk smis are developed under the auspices of public health england phe working in partnership with the national health service nhs, public health.
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