PQM Evaluation of the Laboratory Quality Management System: National Health Product Quality Control Center (NHQC)

The NHQC aims to become ISO 17025:2005 accredited and later World Health Organization (WHO) Prequalified, which will enable it to produce trustworthy and valid results and operate at the highest internationally recognized standards. The NHQC has been receiving technical assistance from the U.S. Pharmacopeia (USP) since 2003, with funding from the U.S. Agency for International Development (USAID). The goal of this assistance is to help the NHQC build its capacity in laboratory techniques, post-marketing surveillance, and ISO 17025 Quality Management System (QMS) awareness. A team from the Promoting the Quality of Medicines (PQM) program, led by Dr. Donnell Charles and Dr. Souly Phanouvong, visited the NHQC in February 2013 to assess its progress and identify areas for improvement. The team evaluated the NHQC's current QMS, equipment, staff competency, and training, and communicated the ISO 17025 standards to the staff. The evaluation revealed that the NHQC is not yet ready for formal ISO 17025 pre-assessments by an accreditation body. The lab is currently in transition as it prepares to move to a new facility by 2015. To address this, the NHQC should focus on updating its standard operating procedures (SOPs), work instructions, forms, and policies to comply with the standard. The PQM program has agreed to provide templates to the NHQC in March 2013, with all templates delivered by May 2013. The NHQC will then draft 25+ ISO 17025 Section 4 documents using the templates, and complete them within 180-240 days. The NHQC will also begin categorizing and organizing all records pertaining to the proposed scope of accreditation, and select a Lead Internal Auditor to support lab audits, inspections, and management review. The NHQC's progress and issues encountered will be reported to the PQM QMS Manager regularly. The PQM program will continue to provide technical assistance to the NHQC to help it achieve its goal of becoming ISO 17025 accredited and later WHO Prequalified. The NHQC's proposed scope of accreditation will be limited to TLC, HPLC, Dissolution, and UV tests, for which the lab has duplicate equipment. Further expansion into the Microbiology area will occur at a later date. The NHQC's staff will be provided with a copy of the ISO 17025:2005 International Standard to review and become more familiar with the standard. The PQM program's technical assistance to the NHQC is part of its efforts to build local capacity in medicine quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally.