Safety laboratory practices

SI 1999/3106 Health and Safety - The Good Laboratory Practice Regulations... 

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

Good laboratory practice (or good scientific practice) is the term used to describe how chemists, and indeed other scientists, should go about their day-to-day work. It covers a variety of characteristics, such as tidiness, cleanliness, care, thoughtfulness, safety, organization and self-discipline. A chemist who has these qualities and uses them is more likely to get the correct results, and get them first time, than someone who does not have them. 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

The "P" has been replaced with "BSL" or Biosafety Level. There are four biosafety levels which are defined according to a combination of facility design, laboratory practices and techniques, equipment and health and safety controls. It is not practical to try to completely describe all of the features and definitions pertaining to biocontainment laboratories in a chapter dedicated to an overview of design. Therefore, we will concentrate on the elements of building design for "maximum containment" or BSL-4 facilities. 

Preclinical studies Animal studies that support Phase I safety and tolerance studies and must comply with Good Laboratory Practice (GLP). Other preclinical studies are done in discovery research laboratories to support drug efficiency claims. 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

The principles of Good Laboratory Practice (GLP) in conjunction with the principles of Total Quality Management (see chapter 6) ensure the quality and reliability of the laboratory results, which in turn help to ensure the protection of the environment and human health and safety. A step further is the accreditation of laboratories to ISO 17025 (see chapter 2) to perform specified activities. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

It is important to ensure the quality and reliability of safety studies. This is normally assured by following the Good Laboratory Practice regulations. Any deviation from this must be justified. 

Food and Drug Administration scientists evaluate the safety studies to determine whether or not the results support a conclusion that the product can be used safely. Until the mid-1970s, the underlying assumption in the agency review was that the reports submitted to the agency accurately described study conduct and precisely reported the study data. A suspicion that this assumption was mistaken was raised in the agency s review of studies submitted by a major pharmaceutical manufacturer in support of new drug applications for two important therapeutic products. Review scientists observed data inconsistencies and evidence of unacceptable laboratory practices in the study reports. 

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