Flow cytometry assays are important for preclinical and clinical research, however, it is vital to understand the level of compliance required for the stage of research you are completing. Flow Cytometry assays completed for toxicology and safety assessments are required to be in compliance of Good Laboratory Practices (GLP), on the other hand, basic research or discovery/exploratory studies can be non-GLP. GLP refers to a set of standards for laboratory studies to be planned, performed, monitored, reported, and archived. Preclinical and clinical studies must be GLP-compliant in order to be submitted for review by regulatory agencies like the FDA. Consider these three points if you find yourself in need of a GLP-compliant flow cytometry assay.
1. Standard Operating Procedures (SOPs).
SOPs are a critical element of GLP assays, which are written procedures for a particular assay. SOPs are typically written as a chronological list of steps. Each SOP is written specifically for the instrument being used and includes routine inspection, cleaning, maintenance, testing, calibration and standardization of the instrument. SOPs also include health and safety precautions, analytical methods, definitions of raw data, sample handling procedures, and data handling and archiving. SOPs are subject to review by regulatory agencies, so it is critical to take the time to write SOPs correctly and seek expert guidance on SOP preparation.
2. Controlled Methods or Assay Protocols.
Creating a Controlled Method is vital to ensure reproducibility of the procedure for the flow cytometry assay. These documents are utilized at the bench in order for scientists to have all details, including but not limited to catalog numbers for materials, step by step procedures, sampling handling, gating strategies and analysis criteria.
Internal and external auditing procedures have been developed for GLP laboratories to assure that GLP standards are being met or to identify areas of weakness. Regular in-house automated auditing procedures help laboratory staff monitor GLP compliance, and external audits are critical for regulatory compliance.
GLP compliance takes a lot of practice and attention to detail, especially when many people are involved. Remember to remain compliant – follow your SOPs, maintain controlled methods, and Audit regularly to ensure GLP accuracy and quality.