2014—2015 (16 months)
Guatemala’s official medicines control laboratory, the Medicines Unit of the National Heath Laboratory (LNS), had a product-based accreditation from the Guatemalan Accreditation Body (OGA) certifying its ability to perform two tests, assay and dissolution, for one product, acetaminophen, according to a specific version of USP-NF (USP35-NF30). PQM recommended changing LNS accreditation from a product-based to a method-based accreditation, which would enable the laboratory to perform the tests within the accreditation scope for all medicines.
To achieve this goal, PQM collaborated with Guatemala’s LNS to strengthen its quality management system (QMS) and prepare the lab for ISO 17025:2005 accreditation by ANSI-ASQ National Accreditation Board (ANAB), an internationally recognized accreditation body. The three methods selected for the initial accreditation were high-performance liquid chromatography (HPLC), ultraviolet visible spectroscopy (UV/VIS), and dissolution. The accreditation status would serve as proof of the lab’s compliance with international standards, and confirm to external parties the trustworthiness and reliability of results generated by the lab. A stepwise, systems-strengthening plan was implemented over 16-months, during which PQM trained lab workers on testing and calibration procedures. This included instruction on how to prepare documents, standard operating procedures, and equipment calibration.
LNS strengthened its quality management system, and attained ISO 17025 accreditation by ANAB in October 2015. The LNS is now poised to expand the scope of accreditation during this fiscal year to include pH, Karl Fischer, and loss on drying.
Strengthening the laboratory’s QMS and attaining ISO 17025 accreditation support Guatemala’s medicines regulatory authority (MRA) core functions. Labs that can effectively identify poor-quality medicines enable regulatory authorities to respond promptly and efficiently to remove them from local markets. This will ultimately help Guatemala’s MRA protect the integrity of the medicines supply chain, and more importantly, the health of its communities. As one of only a few accredited labs in the region, the LNS may also be able to serve as a reference lab, providing assistance to other labs and supporting the testing needs of other countries.
About Guatemala’s LNS
Guatemala’s National Health Laboratory (LNS) in Barcena Villa Nueva serves as the country’s pharmaceutical control laboratory and operates as part a national system of control for pharmaceutical products.
More information on this case example and PQM’s laboratory systems-strengthening work, read this blog article: Fighting Poor Quality Medicines in Guatemala.