PREMIER Laboratory Organization

The organization chart of an organization / laboratory and the quality assurance requirements from the PREMIER model result in specific responsibilities for different areas. Specific tasks and additional responsibilities, e.g. for laboratory areas and equipment, should be defined separately. The responsibilities within the specific work processes should be regulated in the corresponding SOPs.

Laboratory management must have the authority and formal responsibility for the organization and functioning of the laboratory.
This person does not need to be the principal investigator or the head of the department but needs unrestricted support from the upper management of the organization.

Other responsibilities of the laboratory manager(s) include:

• ensure that all personnel working in the lab clearly understand the tasks they are to perform and, where necessary, provide training for these functions
• ensure that appropriate and technically valid Standard Operating Procedures are established and followed
• ensure that the laboratory supplies meet requirements appropriate to their use in a study
• ensure that test and reference items are appropriately characterized
• establish procedures to ensure that data recording systems are suitable for their intended purpose, and are validated, operated and maintained

Continuous maintenance should ensure the reliability and trust in the research results obtained with the laboratory equipment. Resource management is not limited to equipment, but also includes chemicals and biomaterials, as they also play a very important role in the laboratory and influence research results.

Human Resources

The staff working in academic research laboratories typically includes a wide range of individuals with different educational, cultural, etc. backgrounds and with different goals and span of research activities. 

All personnel should be made aware of the importance of training and its impact on the quality of the results. The management should ensure that those assigned to perform research activities have or get the appropriate combination of education, experience and training to be competent with their assignments. When personnel in training is involved in research activities, appropriate supervision should be provided. Job descriptions, and training records should be maintained.

Training should be carried out by personnel with appropriate skills, qualifications and experience.

The following paragraphs follow the structure given in the Best quality practices for biomedical research in drug development ASQ TR1 – 2012 (2).

It is recommended that new laboratory members are registered using a form, if possible, online (faster, less error prone, etc.). Here an example of such a form: download

This form initiates the process of registrations in the various facilities where the particular activities will be realized, speeding up the training processes and including the necessary laboratory tour. The areas of the main laboratory should be shown. At this point, the most important organizational and work safety regulations can be explained directly on the application site.

Especially important is an initial instruction on occupational safety.

Only after completing the training, the new member gets access to the physical and virtual facilities.

Explanation of the principles of Good Scientific Practice must be part of the initial training of each laboratory member and a commitment to follow them must be required. Here an example: download

In a similar way,when the staff member finishes permanently the activities at the department, an analogous reverse process should be followed.  The main objective of this procedure is to ensure that the institution expertise is kept in a transparent manner.

The primary and secondary original data of the experiments should be kept at the institution, preferentially in an electronic laboratory notebook or in any other type of secure data storage device.

Facility and infrastructure

The research institution should have facilities and equipment sufficient for the conduct of the studies and to maintain the infrastructure.

Infrastructure can include:

• Buildings and workspace suitable for the research activities. In particular, lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the test conditions, the accurate functioning of equipment or the safety of the staff.
• Utilities, such as controlled temperature storage facilities, purified water, steam and compressed air, bottled gases.
• Storage areas and test and control mixtures should be separate from areas housing the test systems. It should be adequate to preserve the identity and stability of the reagents and mixtures should be ensured.
• Computer and communications networking
• Equipment to ensure the safety of staff and the integrity of test systems and reference standards
• Premises designed and equipped to afford protection against the entry of insects or other animals
• Limited/restricted access to prevent the entry of unauthorized people.

Premises should be maintained, ensuring that repair and maintenance operations do not affecting the integrity of the testing. They should be cleaned and where applicable, disinfected according to written procedures.

Equipment

Equipment design

Equipment used in the conduct of research activities should conform to the following:

• Equipment should be designed, located and maintained to suit its intended purpose.
• Equipment should be constructed so that surfaces that contact components, in-process materials, or chemical substances should not be reactive, additive, or absorptive so as to affect the test method or test results.

Equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures. Cleaning agents should be effective at removing test residues to eliminate the potential for cross contamination. In addition, cleaning agents should not to be a source of contamination.

• Defective equipment should, if possible, be removed from active use, or at least be clearly labelled as defective to avoid usage until repairs are completed and the equipment is brought back into service.
• Repair and maintenance operations should not negatively affect test results.
• Equipment should be installed in such a way as to avoid contamination.

Equipment calibration

Measuring, weighing, recording and control equipment should be calibrated and checked by appropriate methods for accuracy and precision to ensure valid results. Where necessary, equipment should be:

• Calibrated, at specific intervals, and/or prior to use, against measurement standards traceable to known international or national measurement standards.
• Labelled with the unit's calibration status and date of recalibration
• Safeguarded from adjustments that may invalidate the measurement results
• Protected from damage and deterioration during handling, maintenance and storage.

Data generated by the equipment should be considered suspect should the equipment be found out of calibration at any time. In such cases, an investigation should be initiated to evaluate the validity of data generated during the out of calibration interval.

Records and results of calibration at the time of use should be maintained.

Equipment validation

Although equipment used in research activities typically does not need to be validated to the extent necessary for GLP studies or GMP production, equipment should function as expected so as not to introduce unknowns into the research that may render the results irreproducible. Every user should make sure that the equipment is working properly before using it. The laboratory manager or deputy should be informed in case a piece of equipment does not operate as expected.

List of Laboratory Equipment

Laboratory equipment and infrastructure equipment should be documented in an equipment list. This list should be updated at regular intervals or when necessary. Here an example for such a list:

Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled (3). Validation of methods used in a research institution is critical for the integrity and authenticity of the results.

Validation, e.g. by internal method audits, should demonstrate that the test methods have an adequate level of precision, accuracy, repeatability and robustness. See the Quality Assurance module for the performance of internal audits.

The Laboratory should implement new methods or change standard procedures only after verification and approval by the competent staff. Feasibility assessments are helpful in making this process transparent and understandable.   Complete documentation in the form of SOPs.

Factors such as the handling, storage and quality of materials used in the experiments can affect the outcome.  Ordering, handling, labeling and storage of any materials should be clearly defined, described and documented. Keeping the required of documentation is the responsibility of laboratory management. Legal requirements and institution-specific hazardous material regulations must always be observed.

The professional and safe handling of reagents and chemicals and their safe storage should be subject of the initial instructions and training and it should be addressed with regularly (e.g., a yearly meeting) mandatory instruction on occupational safety and health of all employees of institution.

It is advisable that the institution/laboratory names a qualified person to serve as safety and hazardous substances responsible to support employees and management in complying with the legal and internal guidelines and regulations. This person can point out possible risks and necessary preventive measures. It is recommended that all hazardous substances are recorded in a central hazardous substances register.

Procedures should be in place for the receiving, handling and storage of these supplies to ensure:

• The identity and purity of the material received meets method specifications
• Manufacturer identifier, such as lot or batch number, is recorded and material is not expired
• In-house labeling is used to provide traceability
• Materials are stored under the appropriate conditions
• Labeling clearly identifies the material
• Usage of the materials is tracked
• All secondary containers have labelling that is traceable back to the reference standard or material and at minimum includes:
• Identity
• Preparation date
• Preparer
• Expiry or retest date
• Storage requirements

The entire process of purchasing (ordering, requesting offers, procurement information, incoming goods inspections, logistics, supplier evaluation, monitoring, invoice verification) as well as the strategic planning and central control of the institution relationships with suppliers might be the responsibility of a superior central level specially in big research institutions. However, the lab should have a procedure in place guiding a transparent and objective purchase of items used in research.

The sampling process should address the factors that need to be controlled to ensure the validity of the test and results. Sampling plans, procedures and records generated, should be documented and permanently archived.

The research facility should have in place chain of custody procedures to ensure that collected samples are properly identified, stored and analyzed in a manner that the original sample identification remains and the history of the sample from collection to analysis can be traced if necessary.

It is usually a highly regulated issue. The laboratory should have procedures in place to keep all employees informed about the applicable regulations for hazardous substances, pathogens, fire protection, internal emergency services, etc. This may be achieved either by online or in person regular trainings e.g., once a year. Some items are mentioned above.

There is a growing awareness in the scientific community of the need for standardized reporting on key resources, which has become mandatory for publication in high-level scientific journals (e.g. https://star-methods.com/). A well-structured laboratory will make it easier to meet these requirements, as the information will be readably available.

1. Dirnagl U, Przesdzing I, Kurreck C, Major S. A Laboratory Critical Incident and Error Reporting System for Experimental Biomedicine. PLoS Biol. 2016;14(12):e2000705. Epub 2016/12/03. doi: 10.1371/journal.pbio.2000705. PubMed PMID: 27906976; PubMed Central PMCID: PMCPMC5131907.
2. Trotter AM, Calabrese R, Huang LC, Krumenaker A, Palm U. Best quality practices for biomedical research in drug development. http://asqprinceton.org/wordpress/archives/1300 (accessed on 10.06.2020)
3. ISO 9000:2015(en) Quality management systems — Fundamentals and vocabulary https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en (accessed on 10.06.2020)