Critical Points in OECD GLP TFM Responsibilities
Test facility management (TFM) has a number of critical responsibilities in ensuring the Good Laboratory Practice (GLP) compliance of non-clinical studies.
Test facility management (TFM) has a number of critical responsibilities and these responsibilities can be broadly divided into the following categories:
- Personnel and training: TFM is responsible for ensuring that all personnel involved in GLP studies have the appropriate training and qualifications. This includes training on GLP principles, specific study procedures, and the use of equipment and facilities.
- Facilities and equipment: TFM is responsible for providing and maintaining appropriate facilities and equipment for GLP studies. This includes ensuring that facilities are clean and well-maintained, and that equipment is calibrated and validated.
- Procedures: TFM is responsible for developing and implementing standard operating procedures (SOPs) for all GLP activities. These SOPs should be clear, concise, and easy to follow.
- Quality assurance (QA): TFM is responsible for establishing and maintaining a QA system to ensure that GLP studies are conducted in a compliant manner. This includes regular inspections of facilities, equipment, and procedures, as well as reviews of study data.
Study related specific critical points in OECD GLP TFM responsibilities can be broadly divided into two categories:
Pre-study responsibilities
In-study responsibilities
Pre-study responsibilities
- Selecting and appointing qualified personnel: TFM is responsible for selecting and appointing qualified personnel to perform all aspects of non-clinical studies, including study directors, quality assurance (QA) personnel, and other technical staff.
- Ensuring the adequacy of facilities and equipment: TFM is responsible for ensuring that the facilities and equipment used in non-clinical studies are adequate for the intended purpose and meet GLP requirements.
- Developing and implementing standard operating procedures (SOPs): TFM is responsible for developing and implementing SOPs for all aspects of non-clinical studies. SOPs must be clear, concise, and easy to follow, and they must be based on sound scientific principles.
- Reviewing and approving study plans: TFM is responsible for reviewing and approving all study plans before the start of a study. This includes ensuring that the study plan is complete, accurate, and in compliance with GLP requirements.
In-study responsibilities
- Overseeing the conduct of the study: TFM is responsible for overseeing the conduct of all non-clinical studies to ensure that they are conducted in accordance with the study plan and GLP requirements. This includes conducting regular inspections and audits of the study.
- Ensuring the integrity of raw data: TFM is responsible for ensuring the integrity of all raw data generated during a non-clinical study. This includes implementing procedures to prevent falsification, alteration, or loss of data.
- Ensuring the accuracy and completeness of final reports: TFM is responsible for ensuring that the final reports of non-clinical studies are accurate and complete, and that they meet GLP requirements.
In addition to these general responsibilities, TFM also has a number of specific responsibilities related to critical points in the GLP process. These critical points include:
- Study initiation: TFM is responsible for ensuring that all necessary preparations are in place before a non-clinical study is initiated. This includes ensuring that the study plan has been approved, that all personnel have been trained, and that all facilities and equipment are operational.
- Test item handling: TFM is responsible for ensuring that test items are handled and stored in accordance with GLP requirements. This includes implementing procedures to prevent contamination, degradation, or loss of test items.
- Data collection and recording: TFM is responsible for ensuring that all data generated during a non-clinical study are collected and recorded in a timely and accurate manner. This includes implementing procedures to prevent falsification, alteration, or loss of data.
- Data review and reporting: TFM is responsible for ensuring that all data generated during a non-clinical study are reviewed and reported in a timely and accurate manner. This includes implementing procedures to ensure the integrity and completeness of final reports.
- Archiving: TFM is responsible for archiving all GLP study records for a specified period of time. This includes study plans, raw data, final reports, and other relevant documentation.
- Validation of computerized systems: TFM is responsible for ensuring that all computerized systems used in GLP studies are validated. This means that the systems have been tested and demonstrated to be reliable and accurate.
- Change control: TFM is responsible for implementing a change control system for all GLP-related procedures and systems. This system ensures that any changes are made in a controlled and documented manner.
- Audits: TFM is responsible for conducting regular audits of all GLP-related activities. These audits help to identify and correct any deficiencies in the GLP system.
TFM plays a vital role in ensuring the quality and reliability of GLP studies. By fulfilling their critical responsibilities, TFM can help to protect human health and the environment.
By effectively managing these critical points, TFM can help to ensure that non-clinical studies are conducted in compliance with GLP requirements and that the results of these studies are reliable and reproducible.
