Good Laboratory Practice GLP Requirements

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 

The responsibilities of personnel and the laboratory s management structure must be clearly defined, by means of organizational charts, job descriptions and curriculum vitae for the personnel who are carrying out the study. There must also be up-to-date records of qualifications and of the training that the staff have received, including any records necessary to show their competence to carry out their work. 

A Study Director must be appointed, with overall responsibility for the study and for approving the study plan and any amendments to the study. The Study Director has the responsibility to oversee the technical aspects of the study and so must have appropriate qualifications and experience to be able to supervise the work carried out. The Study Director must ensure that the agreed protocols are followed and that any unavoidable deviations from the protocol are justified and fully documented. The Study Director is also responsible for the following  

There has to be a documented set of procedures for replacing a Study Director should that become necessary. In addition, for multi-site studies there has to be appointed a Principal Investigator for each site. Principal Investigators have to have the appropriate qualifications and experience to manage the delegated part of the study. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

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Good Laboratory Practice (GLP) requires that a quality control (QQ protocol for trace environmental analysis be put in place. A good laboratory QC protocol for any laboratory attempting to achieve precise and aeeurate TEQA requires the following eonsiderations ... 

The quality and reliability of the obtained result are always of prime interest. In research, one has to establish (and maintain and prove) the reliability of analysis in many cases (in the majority of clinical and pharmaceutical applications) one has to comply with regulative and administrative requirements as well. The latter requirements are often in the form of good laboratory practice (GLP) requirements, analogous to good clinical practice in a hospital environment. 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

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 (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

Validation itself is considered a required part of good laboratory practice (GLP) and good manufacturing practice (GMP) within any pharmaceutical laboratory and has been defined by the FDA as ... 

Good Laboratory Practice (GLP) The system provides a comprehensive feature set to aid customers in meeting GLP requirements. This includes features such as certificate-of-software validation, user-access levels, instrument and sequence logbooks, system-suitability software for aU supported HP instruments, standard GLP reports, and a GLP save option that encrypts and saves data and methods together. 

The recent amendment in November 2008 to the drugs and cosmetic rules (II) includes a new Schedule L-1, which covers the Good Laboratory Practices and Requirements of Premises and Equipments, primarily for laboratories that support manufacture. Despite such specific emphasis of its applicability, the details of GLP requirements are in general alignment with those of the OECD, USFDA, USEPA, etc. 

Like any document, the toxicology report must be fit-for-purpose. Its content and format must be tailored to meet the requirements of the reader (not just the convenience of the author). The main difficulties arise because the report has to serve scientific, administrative, and regulatory functions, which often have contradictory constraints. Furthermore, the document must comply with Good Laboratory Practice (GLP) regulations, which are inconsistent between regions or even within the same region for different types of test substance (see Note 1). Once the report has been issued (in draft or final form), it will be consulted by many different experts, each with their own agenda ... 

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