PQM in Latin America/Caribbean

Latin America MapRegional Actvities Around the World/PQM

PQM currently is working on three initiatives in ten countries in the Latin America/Caribbean (LAC) region. Key PQM regional accomplishments include:

  • As a result of technical assistance provided to the Official Medicine Quality Laboratories (OMCLs) of Bolivia and Peru, both facilities have been added to the 16th WHO prequalification list of QC labs. These labs—among the first prequalified in Latin America—can now provide QC services to United Nations agencies and organizations. The Peru OMCL has also achieved accreditation in ISO/IEC 17025:2005.
  • PQM supported the participation of 9 country OMCLs in an inter-laboratory proficiency testing program sponsored by Peru's OMCL as one of its mechanisms to implement sustainable regional collaboration.
  • Based on data from PQM quality monitoring activities, Peru’s medicine regulatory authorities took regulatory actions that resulted in approximately 25,000 substandard medicines being destroyed; the companies holding the products' registrations were also fined.

USAID Maternal and Child Health /LAC Bureau requested that PQM evaluate the quality of emergency obstetric and neonatal medicines in primary care facilities. The reduced efficacy of oxytocin, an essential medicine for preventing postpartum hemorrhage during childbirth, in certain countries raised concerns about the possibility of poor storage conditions affecting the quality of this and other medicines. Pilot studies are underway in decentralized regions in Guatemala and Peru, where deficiencies in the supply chain, such as procurement practices and/or storage conditions, could pose a greater risk for the women and newborns getting assistance in those facilities.

Click on the links below to learn more about PQM activities.

CountryPQM Activities (may vary by country)
Amazon Malaria Initiative (AMI)
Bolivia
Brazil
Colombia
Ecuador
Guatemala
Guyana
Panama
Peru
Suriname
  • Assessing and strengthening quality assurance (QA) and quality control (QC) systems and capacity
  • Establishing a OMCL program as part of postmarketing surveillance
  • Building capacity of the OMCL
  • Conducting onsite training on test methods, Minilab® use, Good Manufacturing Practices (GMP) standards, good distribution practices, good storage practices, and advanced analytical test methods
  • Preparing for WHO prequalification application
  • Assisting to implement quality management system (QMS) compliant with ISO/IEC 17025:2005 and WHO GPCL
  • Participating in a regional QC laboratory network
  • Presenting workshops on medicine quality
  • Conducting a QMS audit
  • Participating in USP's Visiting Scientists program
South American Infectious Disease Initiative (SAIDI)
Bolivia
Paraguay
Peru
  • Assessing QA and QC systems and capacity
  • Establishing a medicine quality monitoring program as part of postmarketing surveillance
  • Building capacity of the OMCL
  • Conducting onsite training on test methods and on WHO drug registration software and procedures
  • Advancing a medicine registration system
  • Assisting to implement QMS compliant with ISO/IEC 17025:2005 and WHO national pharmaceutical control laboratories
  • Presenting workshops on medicine quality
Study on the Quality of Maternal and Child Health Medicines
Guatemala
Peru
  • Conducting research