GLP principles

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... 

It can be seen that the GLP principles do cover similar requirements to both ISO 9001 and ISO/IEC 17025 but data generated solely under these standards would not generally satisfy the principles of GLP. This is mainly in the area of documentation. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

A GLP audit report will identify any deviations from the GLP principles or other deficiencies found at the time of audit. These deficiencies may be minor ... 

The AMFC Directive requires that food control laboratories should be accredited to the EN 45000 series of standards as supplemented by some of the OECD GLP principles. In the UK, government departments have nominated the United Kingdom Accreditation Service (UKAS) to carry out the accreditation of official food control laboratories for all the aspects prescribed in the Directive. However, as the accreditation agency will also be required to comply with the EN 45003 Standard and to carry out assessments in accordance with the EN 45002 Standard, all accreditation agencies that are members of the European Cooperation for Accreditation of Laboratories (EA) may be asked to carry out the accreditation of a food control laboratory within the UK. Similar procedures will be followed in the other Member States, all having or developing equivalent organisations to UKAS. Details of the UK requirements for food control laboratories are described later in this chapter. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment. GLP principles are explicitly presented below. 

The Study Director is the single point of the study control and has the responsibility for the overall performance of the study and the final report. He or she is the delegated individual from the laboratory management to make sure that the laboratory performs under the GLP principles. His or her responsibilities are shown on this and the next shde. 

The role of the quality assurance personnel is to inspect the laboratory activity and verily that this activity complies with the GLP principles. 

They have access to the study plans and Standard Operating Procedures and all updated versions. QA personnel verify in a documented way the compliance of the study plan with the GLP principles... 

Access to the updated study plans and SOPs Documented verification of the compliance of study plan to the GLP principals Inspections to determine compliance of the study with GLP principles. Three types c inspection... 

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. 

Pharmaceutical, medical, and biotech industries are regulated worldwide to be in compliance with cGMP and GLP principles. Each company is required to create validation SOPs to qualify its equipment, utilities, buildings, and personnel. The template validation SOPs available enable end users to understand principles and elements of GMP and provide documentation language ranging from generic to specihc, depending on the detail level of the requirements. 

Applying GLP principles to field studies and analytical chemistry operations will require identifying those operations that are unique to the type of study and discipline. In this regard, the importance of creatively adapting principles developed from in-house monitoring situations to field study operations has been discussed. The differences between QC and QA have been defined. Inspection... 

The study director represents the central point of control with ultimate responsibility for the overall conduct of the study. This is the prime role of the study director, and all responsibilities as outlined in GLP principles stem from it.6 The study director accomplishes this by coordinating inputs of management, scientific/technical staff, and the QA program. 

Replacement Because the study director has responsibility for the overall conduct of a study according to the GLP principles, he or she must ascertain that every phase of a study fully complies with these principles, that the study plan is followed faithfully, and that all observations are fully documented. Theoretically, this responsibility can only be fulfilled if the study director is present during the whole study. This is not always feasible in practice, and there will be periods when replacement may be necessary. Although the circumstances under which a study director would be replaced are not defined in GLP principles, they should be addressed by the facility SOPs. These SOPs also should address procedures and documentation necessary to replace a study director. 

There are many misconceptions surrounding GLP principles. For example, sponsors often believe that the GLP provisions may be applied to the testing of samples from clinical studies. However, the introductions to the FDA GLPs... 

Similarly the OECD GLP regulations (GLP Principles No. 1 in the series) begin with the definition of scope and terminology (section I, Scope and Definition of Terms), followed by 10 subparts (section II) providing minimal requirements for the following ... 

OECD. No. 5 Compliance of Laboratory Suppliers with GLP Principles, revised 1999. http //www.olis.oecd.org/olis/1999doc.nsf/LinkTo/env-jm-mono(99)21... 

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