title: [Strengthening the Pan American Network of Official Medicines Control Laboratories].
abstract: Objective Official Medicines Control Laboratories (OMCLs) play a critical role in quality assurance. The objective of this work is to describe the actions taken by the Pan American Health Organization (PAHO) to strengthen OMCLs in the Region of the Americas. Methods A descriptive study was conducted by the External Quality Control Program (EQCP) to assess the diagnostic and overall performance of OMCLs; human resource training; measures adopted by the Pan American Network for Drug Regulatory Harmonization (PANDRH) to facilitate prequalification of OMCLs by the World Health Organization (WHO) as reference laboratories for United Nations agencies; and the technical documents developed by the Working Group on Good Laboratory Practice (WGGLP) and their level of implementation. Results The Pan American Network of OMCLs, established in 2005, is currently composed of 28 OMCLs in 23 countries. The EQCP assessed the performance of OMCLs in ten stages; 784 professionals, 313 of them from OMCLs, received training in good laboratory practice (GLP). Guidelines for external evaluation and self-evaluation were developed. Six OMCLs attained WHO prequalification and nine became regional reference laboratories. Conclusions The initiatives undertaken made it possible to strengthen the activity of the OMCLs and to train human resources. Furthermore, they provided tools for continuous improvement through external evaluation and self-evaluation.
authors.forename: José María
authors.initials: JM
authors.lastname: Parisi
authors.forename: Damián
authors.initials: D
authors.lastname: Cairatti
authors.forename: José Luis
authors.initials: JL
authors.lastname: Castro
mesh_terms: D000569:Americas; D019983:Guideline Adherence; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010175:Pan American Health Organization; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D014481:United States; D014944:World Health Organization
chemical_list: D004364:Pharmaceutical Preparations