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GLP definition

The GLP definition of batch differs from that found in FDA s CGMP regulations [ 210.3(b)(2)] [10]. The CGMP definition relates any one batch to a defined cycle of manufacture. The GLP definition, on the other hand, relates batch to a characterization process thus, for example, a GLP batch may be part of a CGMP batch or may be the result of a combination of two or more CGMP batches. The only GLP requirement is that a batch be characterized as to identity, strength, purity, and composition or other appropriate characteristics. [Pg.50]

According to the GLP, SOPs are defined as procedures that contain the details of how specified tasks are to be conducted. The GLP definition of SOP merges the International Organization for Standardization (ISO) definitions of procedure and work instructions where procedure is a general statement of policy that describes how, when, and by whom a task must be performed and work instructions contain the specific details of how the laboratory or other operation must be conducted in particular cases [2]. [Pg.198]

Although there is nothing in the definitions section of the GLP regulations to rival RGRAs rewriting of the basic laws of chemistry and physics, a clear understanding of GLP definitions is essential to a proper interpretation of GLP requirements. [Pg.29]

Worker safety studies are not likely to normally include a control substance (i.e., a material used in the study to serve as basis of comparison with the test substance). However, if a control substance is included as a treatment group, then it must (1) be fully characterized as to its identity, purity (or strength), and stability (and solubility, if appropriate) (2) be appropriately tested in mixtures with any carrier used and (3) meet all the other GLP recordkeeping, labeling, and storage requirements, as specified for the test substance. There is some regulatory relief here, however, in that water, by definition, is excluded from being considered a control substance, and vehicles (those substances added to enhance solubilization or dispersion of the test substance) are addressed separately in the FIFRA GLP Standards. [Pg.154]

The background to this set of requirements has already been discussed in Chapter 2. It should be remembered that GLP relates to a study and not to specific tests. In fact, in some respects, it is very narrow in its scope of application as it is only a requirement for regulatory studies. The definition of a regulatory study was given in Chapter 2. A nominated monitoring authority will judge compliance... [Pg.219]

Work To Date. From 1977-80, the most intensive and productive OECD activities focused upon Mutual Acceptance of Data (MAD) and the development of test guidelines and GLP s. Efforts also were devoted to the Step Sequence Group and, in particular, that body s efforts to develop a Minimum Pre-Marketing Set of Data (MPD). Technical and scientific work also progressed on the various hazard assessment issues and expert groups worked on recommendations concerning confidential data, definitions of key terms, and principles of information exchange. [Pg.51]

The first section in each set is titled "General Provisions." In this section, in separate numbered paragraphs, the scope of the regulations is laid out (see Boxes 7.2 and 7.3), a number of definitions are listed, and the applicability of the regulations to studies performed under grants and contracts is covered. Also presented is a paragraph that indicates that the inspection of a testing facility is permitted. Besides these, the EPA GLP includes a statement of compliance or non-compliance as well as a statement on the effects of non-compliance. [Pg.58]

Box 7.4 Definitions of some terms selected from the EPA and FDA GLP regulations. [Pg.62]

Chapter 2 provides a definitive review of the current version of FDA GLPs, including an analysis and interpretation of the enforcement of the GLPs. This summary is an excellent... [Pg.4]

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. [Pg.29]

Although the GLP revisions of 1987 excluded animal feed and water from the definition of control article, it would appear that such common vehicles as saline solutions and carboxymethylcellulose solutions still fall within the definition. Such a strict definition of the term for such innocuous vehicles as saline solutions is quite burdensome when one considers the requirements for control articles that are found in other sections of the GLPs characterization [ 58.105(a)], stability testing [ 58.105(b)], sample retention [ 58.105(d)], and inventory [ 58.107(d)]. It does not appear that this comprehensive definition is enforced by FDA field investigators in the course of GLP inspections. [Pg.41]

Many of the issues relating to the definition of nonchni-cal laboratory study were addressed in the discussion of GLP 58.1 (Scope). Field trials in animals includes all efficacy studies of new animal drugs. Such studies are outside the scope of the GLP regulations. This is consistent with the GLP exemption for human clinical trials. The exemption for basic exploratory studies carried out to determine whether a test article has any potential utility would extend to early screening studies of a test article, the results of which are used to determine whether a test article merits further development or not. [Pg.42]

The definition of sponsor indicates who bears ultimate responsibihty for a nonchnical laboratory study. A sponsor may assign the job of actual study conduct and/or reporting, but ultimate responsibility for the study cannot be delegated. The sponsor must thus assure that a nonchnical laboratory study is conducted in comphance with GLP standards, and must supply the statement of GLP comphance or description of GLP noncompliance (conforming amendments statement) that must accompany the submission to FDA of the results of a noncliuical laboratory study (Section XI). The definition does not preclude joint sponsorship of a study. [Pg.45]

If a facility conducts nonchnical laboratory studies, it is a testing facility and is subject to inspection by FDA to determine its GLP comphance status. If a facility conducts nonchnical laboratory studies as well as studies that do not meet the definition of nonchnical laboratory study, then only those portions of the facihty that conduct nonchnical laboratory studies are subject to a GLP inspection by FDA. The portions of the facihty that conduct studies other than nonchnical laboratory studies are not subject to inspection by FDA unless FDA has inspectional authority under some other set of regulations. [Pg.45]

Equipment used in GLP studies must be validated for appropriateness. Each piece of equipment must have SOPs for operation, calibration, and routine maintenance. All routine and nonroutine maintenance must be documented. What is the definition of a piece of equipment Any item that can have an impact on the results of an anal5dical procedure. In the typical non-GLP laboratory, records are kept on analytical equipment such as spectrophotometers or gas chromatography units. Under GLP, however, the definition expands to include items such as pipets, thermometers, incubators, refrigerators, and mixing devices, as long as it is possible that the use of the item can affect the outcome of the test. For the non-GLP lab, implementation of this standard will dramatically increase the number of equipment-related SOPs. [Pg.168]

The definition of raw data under GLP is more expansive than in non-GLP work. It includes correspondence, notes, phone records, and any document that relates to the interpretation or evaluation of the data. No raw data can be destroyed under any circumstances. [Pg.171]

The next change in definition has to do with the term that we we have been using. Please note that I have mentioned field studies, ecotox studies, genetic tox studies. What is a "study" The current GLP regulations define a study" as shown below ... [Pg.16]

The definition of "raw data" should be clearly understood. It may include items that on gross inspection may appear strange, but raw data are the product of your efforts and must be handled in conformance with the GLPs. [Pg.40]


See other pages where GLP definition is mentioned: [Pg.57]    [Pg.46]    [Pg.103]    [Pg.57]    [Pg.46]    [Pg.103]    [Pg.982]    [Pg.1036]    [Pg.7]    [Pg.723]    [Pg.487]    [Pg.113]    [Pg.282]    [Pg.30]    [Pg.42]    [Pg.173]    [Pg.265]    [Pg.37]    [Pg.41]    [Pg.55]    [Pg.55]   
See also in sourсe #XX -- [ Pg.152 ]




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