Designing a GLP Compliant Laboratory: Considerations and Best Practices

GLP lab

A GLP-compliant laboratory is crucial for the process of drug development. A GLP laboratory performs numerous analyses, including PK/PD, toxicology, and bioavailability studies. GLP stands for good laboratory practices. GLP is a quality system that monitors the experimental conditions and organizational processes that plan, conduct, monitor, record, and report preclinical, clinical, and safety studies. Let us explore the requirement for designing a GLP-compliant laboratory.

Considerations and best practices for designing a GLP-compliant laboratory

The management, quality assurance, national compliance monitoring authority, and study director are the four foundational fundamentals of a GLP lab. Each has a crucial function in performing and monitoring drug development studies. Although GLP requirements differ from other quality systems, there are some overlaps between them. 

A GLP-compliant assay service provider should focus on nine core aspects while designing a GLP lab, including:

  1. Managing test facility
  2. Quality assurance
  3. Fulfilling laboratory requirements
  4. Equipment
  5. Handling and storage
  6. Standard operating procedures
  7. Study performance
  8. Reporting of results
  9. Storage of results and records

The following sections discuss these core aspects in brief.

Test facility includes operational units, premises, and personnel that conduct the preclinical, clinical, and environmental study.

Quality control includes the authority, procedures, and process of accepting or rejecting all components, closures, containers, packaging materials, drug products, and labeling. It also includes the review of records and assuring full investigation of drug products.

GLP principles do not have specific requirements for lab location, except it mentions that the lab must be of a suitable size, construction, and site, to fulfill all requirements. Hence, laboratories have complete freedom to define their locations. However, the lab should conform to general rules and regulations.

Equipment used to generate, store, recover and control experimental factors should be located in a suitable position and of adequate capacity and appropriate design. Besides, the equipment record should include the name of the equipment, model, serial number, and copy of operating instructions. Moreover, the equipment should be periodically cleaned, maintained, calibrated, and inspected.

Sample tracking differs among laboratories. Laboratories should have proper channels to receive, handle, and store study samples. Records should include reference item and test item characterization, expiry date, date of receipt, and quantities received. Moreover, the handling, sampling, and storage protocols should be characterized in a specific order to prevent mixups or contamination of study samples.

Standard operating procedures are written protocols for a GLP-compliant laboratory. They are pre-approved procedures indicating the goal and methods. Standard operating procedures ensure the integrity and quality of experimental results.

Performance should be adequately monitored. All standards should be thoroughly followed from the start to the end of the final report. Each study should have a pre-existing written plan, and generated original raw data should be properly stored, as it contributes to the reconstruction of studies and traceability of events. Raw data are the backbone of any experiment. It can be used statistically or directly, depending on the intended applications.

Finally

The storage of records and materials should be appropriate. The study archives should have the study plan, test and reference items, raw data, specimens, final report, master schedules, training, qualification records, personnel records, and validation and maintenance documents.

Must Read: The Role of Non-GLP Studies in Early Drug Development: Exploring the Utility of Flexible and Agile Study Designs

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