China 
Africa 
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Elements of Toxicology and Guidelines
Published in T.S.S. Dikshith, and Safety, 2016
The Good Laboratory Practice (GLP) is concerned with the organizational processes involving all types of studies in a laboratory or test that should be planned, performed, monitored, recorded, and reported. By adhering to the principle of GLP, a laboratory ensures the proper planning of studies and the provision of adequate means to arrive at meaningful study conclusions. The studies carried out according to GLP ensures the quality and integrity of the data generated and allows their use by government regulatory authorities in hazard and risk assessment of chemicals. This prescribes GLP standards for conducting toxicology studies on agricultural chemicals. Compliance with these standards is intended to ensure the quality and integrity of toxicological data. Primarily, GLP is intended to ensure the quality and integrity of data generated in a laboratory on a product. Any violation would occur if a set protocol is not followed. The US EPA has regulations and guidelines suggesting the studies required and how they are to be performed. In fact, today, GLP standards are recognized throughout the world.
Nonclinical Studies
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Consumers and the government recognized in the 1970s a need for quality in preclinical testing of drugs. The response was institution, by FDA, of a quality system known as cGLP. This set of regulations, outlined in Chapter 4, is applied to all safety testing of biopharmaceuticals. For non-FDA-regulated products, such testing may be required by other government agencies responsible for licensing (Chapter 4) products released into the environment and simply contacting humans. It is important to consider the scope of the GLP regulation, stated in 21 CFR 58 “for conducting nonclinical laboratory studies that support or are intended to support applications for research (clinical investigation) or marketing permits for products regulated by FDA” (CFR 1978). The scope further defines nonclinical laboratory studies as “in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety” (CFR 1978). The definition goes on to exclude clinical studies and laboratory studies that are designed as exploratory or to determine potential utility or product characteristics. The scope of GLPs is important in three important respects. First, it does not apply to research, early development, or clinical trials. Second, it excludes quality control of product (which falls under cGMP). Third, it does apply to all laboratory studies, including animal studies, in which a claim is made for product safety. Thus, GLPs apply to most of the work we discussed in this chapter, with the possible exception (if safety claims are not made on the results) of pharmacology studies.
Laboratory tutorials
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2018
Laboratory training is a very critical component of biotechnology education, research, and product development. It is necessary to know basic laboratory techniques in order to shape a career in biotechnology. Keeping this in mind, we have decided to include some of the basic and advanced techniques employed in biotechnology. Since it is not possible to include all the laboratory techniques employed in biotechnology, we have made sure to include fundamental techniques. One of the important aspects of biotechnology laboratory experiments is to understand good laboratory practice (GLP), which has been described in the previous chapter in great detail. However, it will be helpful to shed some light on the significance of GLP in biotechnology research. GLP deals with the organization, process, and conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. GLP is intended to promote the quality and validity of test data. One of the main criteria of GLP-based laboratory experiments is ensuring that all routine work follows written standard operating procedures (SOPs). Facilities such as laboratories should be large enough and should have the right construction to ensure the integrity of a study—for example, to avoid cross-contamination. In addition, instruments employed in the study should be regularly calibrated and maintained. Moreover, raw data should be acquired, processed, and archived to ensure the integrity of the data. Although GLP regulations may not be directly applicable to basic research conducted at academic institutes or universities, there is no harm in conducting laboratory experiments as per GLP guidelines.
A comprehensive validation framework addressing utility parameter validation for application in small and medium enterprises (SMEs):A case study in pharmaceutical industry
Published in Cogent Engineering, 2023
Vothia Surian Subramaniam, Joshua Prakash, Shahrul Kamaruddin, Sze Wei Khoo
LIMS validation framework (International Society of Pharmaceutical Engineers, 2018) plays a major role in achieving Good Laboratory Practice in regulated industries. This is possible because this step flow framework is capable to eliminate manual, tedious and error prone operations. The framework offers appropriate mix of customer and vendor which helps to achieve the validation target effectively. This framework is very comprehensive since it has risk-based validation plan developed by customer and user requirements specification as well as traceability matrix. Capability of obtaining consistency, reliability, integrity and accuracy of data is the positive element of this framework. However, no protocol preparation before conducting qualification is the main pitfall of this framework which may delay the qualification process.
Key operational and institutional factors for improving food safety: a case study from Chile
Published in Production Planning & Control, 2021
Haiyan Lu, Sachin Kumar Mangla, Jorge E. Hernandez, Sebastian Elgueta, Guoqing Zhao, Shaofeng Liu, Lise Hunter
According to ISO/IEC 17025, an international accreditation standard through a national body seem to respond better to the specific need of an official quality control than the quality assurance scheme under Good Laboratory Practice, which is mandatory for the elaboration of studies necessary at national level (FAO 2012). The ISO provide a standard thorough application of a framework for verifying key aspects of a firm’s production process that assures quality (Unnevehr, 2015). However, the legislation standards and implementation levels are fairly diver at national levels, especially in emerging economics, such as Chile, India and China, a result of inconsistency in the enforcement and processes of risk control being reflected in interdisciplinary researches of food safety assessment (Elgueta et al. 2017; RIAL 2016). In this regards, there is a need to examine institutional regulation, enforcement and implementation in each sourcing origin for global food safety control.
A Physiological-Based Pharmacokinetic Model For The Broad Spectrum Antimicrobial Zinc Pyrithione: II. Dermal Absorption And Dosimetry In The Rat
Published in Journal of Toxicology and Environmental Health, Part A, 2021
Gary L. Diamond, Nicholas P. Skoulis, A. Robert Jeffcoat, J Frank Nash
This study was conducted in compliance with the U. S. Food and Drug Administration Good Laboratory Practice Regulations, Title 21 of the U.S. Code of Federal Regulations, Part 58, issued December 22, 1987 (with all applicable revisions); the U.S. Environmental Protection Agency’s Federal Insecticide, Fungicide, and Rodenticide Act Good Laboratory Practice Standards, Title 40 of the U.S. Code of Federal Regulations, Part 160, issued April 1, 1990 (and subsequent revisions); and the Organization for Economic Cooperation and Development’s Principles of Good Laboratory Practice [C(97)186/Final] adopted by Council on November 26, 1997 and all subsequent revisions. Animal study data used in this report come from historical investigations conducted prior to 2007.