An organization or individual risks exposing patients to accident and health hazards, suffering the higher cost of analysis due to investigation, and including legal and regulatory sanctions should good laboratory practice be compromised. The Guest Speaker at the recent Town and Gown Seminar of the Department of Biochemistry, Covenant University, Miss Remilekun Meshioye, has warned.
Miss Meshioye, while making a presentation on “Good Laboratory Practice (GLP)”, said GLP was a set of principles intended to assure the quality and integrity of non-clinical laboratory studies designed to support research or marketing permits for products regulated by government agencies. She added that GLP were standard regulatory programmes that assured the quality and integrity of non-clinical safety test data submitted to regulatory agencies worldwide.
The Guest Speaker, Deputy Quality Control Manager at Fidson Healthcare Plc, said GLP was established to promote the quality and validity of test data used to determine the safety of medicinal products and avoid duplication of research. She noted that GLP helped improve human health and environment protection, facilitate international acceptance of test data, and prevent the creation of technical trade barriers.
She highlighted the principles of GLP as an organizational quality control system covering the administrative process and the conditions under which non-clinical health and environmental studies were planned, performed, monitored, recorded, reported and retained or archived.
While expounding on GLP principles, Miss Meshioye said it was to ensure and promote the safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing.
According to her, some acceptable proof of good training and or competence with specific laboratory procedures must be established for each analyst in an organization while ensuring the review of the final study report to assure methods and standard operating procedures (SOPs) reflect raw data.
She stated that all equipment must be clean, validated, and calibrated before use. All equipment should have a printout for data Integrity; the calibration frequency depended on the instrument and extent of service in the laboratory. Materials and reagents must be used, well labelled, and not be expired, not be expired, she emphasized.
On the test system, the Guest Speaker said the source of a sample must be recorded and unmistakably connected with the analytical data set; there should be a receipt, handling, sampling and storage of materials; and it should conform to the United States Pharmacopeia (USP), and the British Pharmacopoeia (BP)
She advised that organizations must store documents for at least five years due to the probability of legal action on any analysis performed. She said organizations must keep hard copies of documents in archives to provide secure storage and retrieval of study plans, raw data, final reports, and samples of test items and specimens. These, she noted, helped to protect from untimely deterioration