Adopted in 2000 and 2001 by Europe, the USA, and Japan, the International Conference on Harmonization guidelines S7A and S7B require that safety pharmacology studies be conducted in compliance with current Good Laboratory Practices (GLP) whenever possible. The S7 guidelines includes a provision which recognizes the “unique design and practical considerations” associated with some pharmacology studies, and underline the importance of assuring data quality and integrity, even in the absence of strict adherence to the GLPs. Click here to access the 21 CFR Part 58 guideline.
IPST’s facility is GLP-compliant and will soon be accredited by the Standards Council of Canada
Since its creation in 1999, IPST has been been committed to the implementation of a GLP-compliant facility and document tracking system, capable of protecting the integrity of the data within its facility.
Although in vitro electrophysiology studies fall squarely within the category of these studies featuring “unique design and practical considerations,” a thorough validation of all experimental procedures and documentation systems was performed from the onset, and innovative, unique solutions were developed when no commercially-available options existed. These solutions were validated, audited over three dozen times by external auditors and widely applauded by the pharmaceutical industry.
In 2012, IPST moved to a new, custom-built facility. The new laboratories, surgery and housing rooms, server and archival facility have yet to be audited by the new GLP-auditing team within the Standards Council of Canada. IPST is committed to obtain the missing federal GLP accreditation, as soon as the new facility is completed.
Track records and audits
IPST has hosted federal regulatory auditors on two occasions since its inception. In addition, well over two dozen sponsor audits are welcomed every year. Throughout the years, IPST has maintained an excellent and productive working relationship with auditors from all sources, rapidly and efficiently implementing corrective measures following the reception of audit reports. IPST benefits from an experienced team of quality assurance personnel, who audit all critical phases of each study, as well as conduct routine inspections of the facilities and its Standard Operation Procedures (SOP). When necessary, IPST hires external auditors to conduct audits of its facilities, documents, and procedures, to ensure the strictest adherence to current guidelines.