Good Laboratory Practices are a part of a system designed to ensure the accuracy and reproducibility of data and results. By extension, this also underlines the accuracy of the result. GLP studies are regulatory requirements that need to be fulfilled before a drug move beyond preclinical studies. Since GLP forms system and rules, adoption is necessary at the organizational level.
Organizational and Personnel Requirements
Any facility or building used by a GLP lab should be of a size, construction, and location to be conducive to the biotech cro study.
Roles and responsibilities for personnel should be clear. Each person involved in the study should have a job description that details the individual’s roles and responsibilities. All personnel should have adequate training for their job. This goes beyond academic qualification and includes specific training for the study being conducted. Careful documentation at each step and of various processes is necessary.
All equipment, including computerized systems, should be fit-for-purpose and calibrated correctly. They should be well-maintained, validated, and developed to ensure the integrity and safety of processed data. The hardware and software of computers should be clearly defined and, where necessary, validated.
Handling the Trial, Contract, and Related Aspects
Setting up a standard operating procedure (SOP) is a way for the laboratory and sponsor to have a clear understanding of the trial goals. The SOP is backed by contracts and agreements.
A formal agreement is not necessary where the lab is a part of the sponsor organization. However, it is important to have internal memos or policy documents that elaborate on the trial and its goals. This helps set up the SOP and documented policy.
The laboratory should not accept tasks that go beyond the scope of the established SOP. In the same vein, work related to GLP studies is not to be sub-contracted. If either of these changes is necessary, a relevant contract and/or documentation must be added.
For clinical trials that require blinding/unblinding, the integrity of the information is essential. The information should not be compromised at any point, whether it’s sample collection or the laboratory.
Putting Informed Consent and Patient Safety Together
Patient safety takes precedence over any other aspect of a trial. Lines of communication should be established with various stakeholders for fast reporting of any issues that may impact patient safety. There is also a need for actions to implement in case consent is withdrawn. These can be a part of SOP or contract.
A process for safely collecting and transporting samples is important. Proper labeling, storage, and transportation assure sample integrity. Moreover, a clear chain of custody is necessary, whether through receipts and labeling or other methods.
A GLP lab must have a QA process to ensure the integrity and veracity of data. QA also ensures adherence to the best practices. The lab could depute personnel or a department to oversee, audit, and encourage adherence to the best practices.
Reporting and Quality Control
The analysis always needs to be performed with fully-validated methods. There can be some exceptions, like when the trial aims to validate a method.
Reporting of the results and data should be agreed between the lab and sponsor. The format and number of reports can be a part of the SOP. In case long-term storage is required, good lab practices mandate the presence of adequate and suitable storage facilities at the lab.