Principles of GLP

Any facility that produces data in support of these non-clinical studies is required to con ly with the principles of GLP and will be audited for compliance by the appropriate regulatory authority. In the case of the UK this would be the United Kingdom GLP Compliance Monitoring Authority, which is part of the Department of Health. In the USA this would be the appropriate FDA department. 

GLP must not be confused with that part of GMP that is concerned with operations in QC laboratories that assure the quality of medicines for human use (sometimes referred to as good quality control laboratory practice). Although there are a number of similarities in the practical aspects, GLP is in place to assure the integrity and quality of data GMP is there to assure the quality of the product, i.e. its conformance to specification. There have been a number of statements recently from FDA sources on this subject [10]. 

FDA does not care how a company refers to its practices. It cares about what those practices are.  

One could of course argue that assurance of the integrity of data is also a requirement under any other quality system such as GMP. This assurance requires that analysts are trained, that procedures are written and approved, that analytical equipment is calibrated and maintained, that reagents and test materials are controlled and that accurate records and original raw data are kept. 

---

The final reporf should be signed and dafed by fhe Sfudy Direcfor to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of GLP should be indicated. 

Include a disclaimer or deviation in the Study Director GLP compliance statement. The disclaimer route can be used for a phase of a multi-site study but should generally not be used if the work in question is a critical phase, e.g., application. The remainder of the study must be conducted in accordance with the principles of GLP. This route may not be acceptable to overseas regulators and should be avoided if possible. 

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 computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Adherence to basic principles of GLP to ensure quality of the study including a detailed protocol prepared prospectively. 

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. 

Data from studies in animals according to test guideline methods, particularly if conducted in accordance with principles of GLP, will usually give very good information in order to identify whether a substance would be considered to be, or not to be, corrosive or irritant to the skin or eye in the test species. In general, it is assumed that substances, which are irritant in test guideline studies in animals will be skin and/or eye irritants in humans, and those which are not irritant in test guideline studies will not be irritant in humans. 

The principles of GLP ensure the generation of high quality and reliable test data related to the safety of industrial chemicals, pesticides, pharmaceuticals, food and feed additives, cosmetics, veterinary drags as well as food additives, in the framework of harmonizing testing procedures for the mutual acceptance of data. 

OECD Member States developed the OECD principles of GLP, utilising common managerial and scientific practices and experience from varions national and international sources. The purpose of these principles of good laboratory practice is to promote the development of quality test data. 

The laboratoiy should have a documented Quality Assurance Programme, carried out by designated individual(s), to assure that the activities perfonned are in compliance with the principles of GLP. The QA personnel must conduct inspections to determine if all of the laboratory activities are conducted in accordance with the principals of GLP and defined SOPs. These personnel... 

Nondinical assessment of cardiac safety must be performed for a compound to qualify to be submitted to the health authorities to begin studies in man. For this purpose the regulatory bodies require that the cardiosafety assays should follow the principles of GLP wherever possible. The following assays/technologies are frequently used to predict potential clinical QT liability. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

In addition to the development of the OECD Principles of GLP, the OECD Expert Group was given the responsibility of developing two additional guidance documents—one for the Implementation of OECD Principles of GLP and one as OECD Guidelines for National GLP Inspections and Study Audits. 

The Implementation document encourages member countries to adopt the OECD Principles of GLP into their legislative and administrative frameworks. As a part of the adoption and... 

Since not all GLP elements apply to all studies the proposed regulations are based upon those principles of GLPs that are applicable to that type of study. 

For studies that have delegated responsibilities to a PI, the study director will rely on that individual to ensure that relevant phase)s) of the study are conducted in accordance with the study plan, relevant SOP, and principles of GLP. The PI should contact the study director when event(s) occur that may affect the objectives defined in the study plan. All communications should be documented. Communication between the study director and the QA is required at different stages of the study. For instance (1) to review study plans (2) to review new and revised SOPs (3) attendance of QA personnel at study initiation meetings and in resolving potential problems related to GLP (4) by responding to inspection and audit reports promptly (5) by indicating corrective action and (6) by necessary liaison with QA staff, and scientific and technical personnel. In certain unforeseen conditions, change of study director becomes essential. Under such conditions, replacement of the study director should take immediate effect. 

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Adherence by test facilities to the principles of GLP ensures that there is a proper plan-... 

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... 

OECD. No. 10 The Application of the Principles of GLP to Computerised Systems, 1995. http //www.olis.oecd.org/olis/1995doc.nsf/LinkTo/ocde-gd(95)115... 

---