Facilities and equipment

The GLP Principles emphasise that facilities and equipment must be sufficient and adequate to perform the studies. The facilities should be spacious enough to avoid problems such as overcrowding, cross contamination or confusion between projects. Utilities (water, electricity etc.) must be adequate and stable.

All equipment must be in working order; a programme of validation/qualification, calibration and maintenance attains this. Keeping records of use and maintenance is essential in order to know, at any point in time, the precise status of the equipment and its history.

Characterisation

In order to perform a study correctly, it is essential to know as much as possible about the materials used during the study. For non-clinical studies intended to evaluate the safety related properties of pharmaceutical compounds, it is a prerequisite to have detailed knowledge about the properties of the test item, and of the test system (often an animal or isolated part thereof) to which it is administered.

Characteristics such as identity, potency, composition, stability, impurity profile, etc. should be known for the test item, for the vehicle and for any reference material.

If the test system is an animal (which is very often the case) it is essential to know such details as its strain, health status, normal biological values, etc.

Rules

Protocol or study plan

The study plan or protocol outlines the design and conduct of the study and provides evidence that the study has been properly thought through and planned: the principal steps of studies conducted in compliance with GLP are thus described in the study protocol.

The protocol must be approved by the Study Director, by dated signature, before the study starts. Alterations to the study design can only be made through formal amendment procedures. All this will ensure that the study can be reconstructed at a later point in time. The GLP Principles list the essential elements to be included in a study protocol.

Written Procedures

It is not reasonable to include all the technical details of study conduct in the protocol. The details of all routine procedures are described in Standard Operating Procedures (SOPs) which are part of the documentation system of the institution. SOPs contribute to reducing bias in studies by standardising frequently performed techniques. Laboratories also need to standardise certain techniques to facilitate comparison of results between studies; here again written SOPs are an invaluable tool. To be able to exactly reconstruct