Good laboratory practice final report

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

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 ... 

Good Laboratory Practice deviations that were of a continuing nature throughout the course of a study will require a conforming amendments statement of the reason for the noncompliance. One-time deviations from GLP requirements should be documented in study records and should be described in the final report but will not require a conforming amendments statement of the reason for the noncomphance. 

Good Laboratory Practice in the Testing of Chemicals, Final Report of the Group of Experts on Good Laboratory Practice. No. 42353, Organization for Economic Cooperation and Development 2 rue Andre-Pascal, 75775 Paris Cedex 16, France, 1982. 

While it is the Study Director who is ultimately responsible for the quality of the study as a whole, he/she cannot be held responsible for the quality of each and every data point and each and every single record. This is clearly the domain of responsibility of the study personnel, who are are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the equality of their data . Certainly, these raw data will be scrutinised by the Study Director, who will use them for the preparation of the final study report certainly these raw data will be checked by Quality Assurance for their compliance with the provisions of the GLP Principles. However, data quality cannot be obtained retrospectively by control measures ( quality cannot be controlled into the data ), data have to be recorded in such a way that quality is an intrinsic characteristic of these records. Thus, this responsibility of study personnel for the quality of their data cannot be emphasised strongly enough. 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s) this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed. 

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