Center for Pharmaceutical Advancement and Training (CePAT)

CePAT Announcement by Dr. Patrick Lukulay, V.P., Global Health Impact Programs

The latest offering under USP’s Global Health Impact Program umbrella is the establishment of a facility known as Center for Pharmaceutical Advancement and Training (CePAT). CePAT is scheduled to open in 2013 in Accra, Ghana, and will serve all of Sub-Saharan Africa (SSA)—a region facing serious health issues and a proliferation of substandard and counterfeit medicines. CePAT will strive to build SSA’s human resource capacity in pharmaceutical quality control by developing local talent to serve as technical experts in the quality control (QC) and the quality assurance (QA) of medicines. USP envisions CePAT to be the start of a transformative, global initiative that can be expanded to help at-risk communities worldwide.

CePAT Services

CePAT will provide an integrated platform of training, education, consulting and laboratory capabilities that offers a sustainable, systemic approach to medicine QC/QA in SSA. Regulators and Official Medicines Control Laboratories, manufacturers, donor agencies, procurement organizations and others can benefit from CePAT services, which will include

  • Comprehensive training in the QC and the QA of medicines, including hands-on laboratory training
  • Training in laboratory quality management systems and good laboratory practices (GLP)
  • Training in current good manufacturing practices (cGMP)
  • Certification of laboratory personnel in QC procedures
  • Third-party testing of medicines for governments and global health initiatives
  • Consulting on supply chain integrity to prevent and detect adulteration of medicines

Why CePAT Is Important to SSA

SSA countries and their regulatory authorities face fundamental oversight and resource deficiencies, including a shortage of qualified personnel at national laboratories, that have created an environment where substandard and counterfeit medicines have flourished, and, as a consequence, so have serious diseases and drug resistance.

SSA countries are heavily dependent on medicines imported from outside of the region, and there is limited regulatory oversight both prior to export and after import. In addition to imported medicines, medicines produced locally in SSA countries often fail to comply with cGMP. (Read More)

The public health impact in SSA is dire. Poor quality and counterfeit medicines have contributed to the development of antimicrobial resistance and the exacerbation of life-threatening illnesses that may otherwise be treatable with good quality medicines, such as malaria, tuberculosis, and HIV. SSA has the lowest life expectancy, the highest infant and under-five mortality rates, as well as the highest maternal mortality ratio, of all regions in the world (2009 data)1. It also has the highest burden of HIV prevalence among adults, malaria mortality rate (per 100,000) and tuberculosis prevalence (per 100,000) in the world2.

Professional training to help combat substandard medicines has been limited in funding and scope. QC/QA training for national laboratories carries significant cost to Ministries of Health, and funding has tended to be sporadic and not based on a comprehensive curriculum to achieve the level of competency required to conduct full-scale medicines quality control. Donor funds for training sometimes support disease-specific programs only, having little or no systemic impact on the entire spectrum of QC/QA activities and the health system as a whole.

CePAT aims to help SSA overcome this resource shortfall by offering countries in the region a permanent regional center for training, education, consulting, and laboratory services that can be delivered on-demand and tailored to local needs. Through CePAT, USP hopes to help SSA communities stimulate systemic improvements that can be sustained through their own well-trained staff at well-built, well-equipped, and well-managed local facilities.

Resources

  • Contacts
    • CePAT Program Information: Dr. Patrick Lukulay, V.P., Global Health Impact Programs, +1-301-816-8166, phl@usp.org
    • CePAT Donor Information: Reema Jweied-Guegel, V.P., Development, +1-301-816-8220, rjg@usp.org

1 Global Health Observatory Data Repository; http://apps.who.int/ghodata/

2 WHO 2011, Health Situation Analysis in the African Region, Atlas of Health Statistics—2011, WHO, Geneva