Testing facility management

Quality assurance unit Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the (non-clinical laboratory) studies. 

Testing facility management Study director Quality assurance unit General... 

Test facility management Test site management Sponsor Study director Principal investigator Quality assurance program Standard operating procedures Master schedule... 

I.Test Facility Organization and Personnel Test Facility Management s Responsibilities... 

For each nonclinical laboratory study, testing facility management shall... 

The study is performed according to a plan approved (by dated signature) by the study director and verified for CLP compliance by the QA unit. Some countries also require formal approval by the test facility management and the sponsor. The plan should usually contain identification of the study, the test item and reference item, information concerning the sponsor and the test facility, dates, test methods, documents and materials to be retained, and other issues that have been identified. 

For each nonclinical laboratory study, testing facility management shall...(c) assure that there is a quality assurance unit. (e) ensure that personnel, resources, equipment, materials, and methodologies are available as scheduled, (f) assure that personnel clearly understand the functions they are to perform, (g) assure that any deviations from these regulations reported by the quality assurance unit are communicated.. . and corrective actions are taken and documented. 

Personnel Organization (1) personnel (2) testing facility management ... 

Each test facility management should ensure that it complies with GLP. 

A test facility should have written SOPs approved by test facility management. Performing studies based on written SOPs is strongly encouraged, since it helps to minimize systematic errors. By following an SOP at each step, the chance of inadvertent mistakes could be avoided. Therefore, each student or worker should be familiar with the SOPs to perform different studies. In fact, adherence to an SOP enhances the quality and integrity of the data generated. 

The approval date of the study plan by signature of the test facility management. 

It is not by sheer coincidence that management would be mentioned here in the first place as one of the pillars of GLP. It is amply borne out by experience that GLP is only as well complied with as it is supported by test facility management s inner conviction. It is not sufficient to draft a nice declaration extolling the virtues of quality in general and of GLP in particular, when in everyday work the wrong cues are given to the test facility personnel... 

All this amounts to the requirement that it is the test facility management, who is ultimately responsible for ensuring full compliance with the GLP Principles throughout the facility as a whole. In order to deliver its responsibility, it will need some mechanism of continuous control. Therefore, an essential management responsibility is the appointment and effective organisation of an adequate number of appropriately qualified and experienced staff throughout the facility, including those specifically required to perform QA functions. 

In summary, four pillars support the structure of Good Laboratory Practice. All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data. Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end. 

In order to attain its purpose, any quality system needs to define very clearly the different levels of responsibility. The definition of the test facility management serves to delineate these responsibility borderlines, and it invests test facility management with the ultimate power for ensuring GLP compliance. 

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