GLP regulations

US GLP Regulations, Code of Federal Regulations, Title 21, Part 58. www.fda.gov. 

In preclinical development, the GMP/GLP regulations are enforced not only for scientific data but also for text documents. This section discusses several types of controlled text documents used in preclinical development. Most of these documents are managed by the fully validated TIMS. 

The use of proper clothing and protective equipment is mandated not only by common sense and worker safety laws and policies, but also by GLP. The GLP regulations 40 CFR 160.1(a) and 160.3(4), state that attire appropriate to the task must be worn. The type of protective equipment appropriate to the trial must be determined by the Study Director and local management. The Latin American Crop Protection Association (LACPA) is an excellent source of safety training videos and brochures in the Spanish language. 

Good Laboratory Practice (GLP) regulations and their impact on the small-scale processing procedures... 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

The GLP Pocket Book the Good Laboratory Practice Regulations 1999 and Guide to UK GLP Regulations 1999, MCA Publications, London, 1999. 

Guide to the UK GLP Regulations 1999. Department of Health, The United Kingdom Good Laboratory Practice Monitoring Authority, 2000 London MHRA Publications. 

Both the ISO 9000 guidelines (ISO/IEC Guide 25 — see Section 2) and the GLP regulations (e.g., FDA regulations 21 CFR 58) stress the importance of the calibration of laboratory equipment. (See Box 5.3.) Indeed, properly calibrated test equipment is central to a laboratory s duty to successfully and accurately carry out its responsibilities. 

Box 7.4 Definitions of some terms selected from the EPA and FDA GLP regulations. 

Box 7.6 Paragraphs within the FDA GLP regulations relating to compliance or non-compliance with the regulations. 

Subpart E of both the FDA and the EPA GLP regulations addresses the operations aspects of the work. This is the subpart that specifies the use and design of standard operating procedures that was discussed in Section 5.2 (see Box 5.1... 

Laboratories may indicate that they do quality work and adhere to GLP regulations and/or ISO guidelines, but they must also prove that they do so. Thus, the GLP regulations provide for audits by the quality assurance unit as well as by EPA or FDA inspectors, and ISO registration will also involve an audit process. 

Facility Audit The facility audit includes all aspects of the facility that are listed in the GLP regulations. These include the personnel (Subpart B) as well as the laboratory itself (Subpart C), the equipment used in the laboratory (Subpart D), the test substances, reagents, and samples used (Subpart F), and the laboratory information systems. 

Commonly Found Errors According to an American Chemical Society short course in which the concepts of GLP regulations and ISO 9000 accreditation are discussed, errors that the QAU commonly finds in the course of its work are mostly errors of record-keeping. The list provided at the short course is reproduced in Box 8.1. 

What two federal agencies have GLP regulations Briefly describe their similarities and differences. 

Define the following terms from the GLP regulations quality assurance unit, raw data, person, sponsor, study, study director, test system. 

What statements in the GLP regulations give the government the right to enter and inspect a laboratory facility ... 

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