Center for Pharmaceutical Advancement and Training (CePAT)
The Center for Pharmaceutical Advancement and Training (CePAT),launched in May 2013, aims to equip national and local regulatory authorities and officers, quality assurance and quality control professionals, manufacturers, and others in the pharmaceutical industry with knowledge and skills to promote access to good quality medicines. CePAT serves all of Sub-Saharan Africa—a region facing serious health issues and a proliferation of substandard and counterfeit medicines. A USP Global Health Impact Program, CePAT fulfills USP’s core mission of establishing public standards for the quality of medicines, foods, and dietary supplements and serves as its Commitment to Action through the Clinton Global Initiative.
- CePAT, GPHF Form Strategic Alliance
- First Classes Graduate from CePAT
- USP, Ghana Officials Open CePAT in Accra
Upcoming Courses at CePAT–2014 Dates
- July 7-18, Good Manufacturing Processes
- Sept 1-12, Dossier Evaluation
- Nov 3-14, Pharmaceutical Quality Control
The Center for Pharmaceutical Advancement and Training (CePAT) and the Global Pharma Health Fund (GPHF) are working together to improve access to good quality, safe, and beneficial medicines. The two organizations recently signed a formal agreement that will strengthen human resource capacity to conduct quality control testing to detect substandard and counterfeit medications in Africa. GPHF is a charitable organization initiated and funded exclusively by donations from Merck KGaA (Darmstadt, Germany) that produces the Minilab®, a mobile mini-laboratory used by many countries with limited resources to screen for medicines quality in the marketplace, clinics, satellite laboratories, or ports of entry. This alliance promises to improve local capacity to detect substandard and counterfeit drugs through training at CePAT’s facility in Ghana on the use of the GPHF-Minilab®. Promoting the Quality of Medicines —another USP global health impact program implemented for the United States Agency for International Development—installs Minilabs® in surveillance sites of participating countries as part of a comprehensive medicines quality monitoring system. The Minilab® has proved instrumental in the early detection of substandard and counterfeit medicines in Ghana and numerous countries in Africa, Asia, and Latin America.
First Classes Graduate from CePAT, Improving Good Manufacturing Practices and Laboratory Quality Control
Since its inauguration in May 2013, CePAT has graduated three training groups and conducted three customized courses on Management Orientation, Regulatory Inspection and Health Systems Supervision, and PQM GMP Compliance Roadmap for individual clients. The center's initial two-week training session offered dossier evaluation and medicines registration training to individuals from six African countries—Ethiopia, Ghana, Kenya, Nigeria, Senegal, and Sierra Leone. The 18 participants represented both medicines regulatory authorities and private pharmaceutical companies. Besides teaching good practices and basic concepts, the module used case studies to illustrate real-world application of important theory in dossier assessment and registration, allowing trainees to hone their skills. At the end of the two-week session, the group took what they learned back to their home countries to put it into practice; they are scheduled to return to CePAT in Spring 2014 for additional training on advanced topics.
In September, training commenced on Good Manufacturing Practices (GMP) for a group of 22 candidates from 7 African countries— Ethiopia, Ghana, Kenya, Liberia, Nigeria, Sierra Leone, and Zambia; 12 of them were self-sponsored. Students learned about the history and concepts of GMP and related good practices, and came to appreciate the key role GMP plays in ensuring the manufacture of safe, efficacious, and good quality medicines. The course covered a broad range of topics, including documentation, qualification and validation, and quality management, and also provided information on the World Health Organization (WHO) Prequalification Programme.
The module on Pharmaceutical Quality Control was offered in November to a class of 26 from 7 countries—Ethiopia, Ghana, Kenya, Nigeria, Senegal, Sierra Leone, and Zambia; 14 of those were self-sponsored. The number of participants required the class to be divided into two groups; alternately, each group received theoretical and hands-on laboratory training in the scientific approach and basic quality control techniques used in analytical laboratories. Exercises covered basic laboratory techniques as well as chromatographic, spectrophotometric, and drug release techniques, and incorporated good laboratory practices.
The latest offering under USP’s Global Health Impact Program umbrella, the Center for Pharmaceutical Advancement and Training (CePAT), was inaugurated on May 13, 2013, in Accra, Ghana. Prominent national and international dignitaries as well as USP board members and staff attended the opening ceremonies. Miss Sherry Hanny Ayittey, Minister of Health for the Republic of Ghana, and The Honorable Mr. Gene A. Cretz, U.S. Ambassador to Ghana, addressed the audience, highlighting how having a well-trained workforce is crucial to success in combating substandard and counterfeit medicines and providing access to good quality medicines to the population of Ghana and Sub-Saharan Africa (SSA). Mr. Cretz noted that "improvements in this area are critical, and CePAT will play a vital role in tackling this problem. The U.S. President's Malaria Initiative and USAID activities laid the groundwork for establishing USP in Ghana, and we are proud to be part of this." Dr. Stephen K. Opuni, CEO, Food & Drugs Board of Ghana, also commended USP for showing interest in the development of pharmaceutical businesses in Africa and the protection of public health.
In his remarks, Dr. Roger Williams, USP CEO, said that "CePAT is a natural extension of USP’s core mission of establishing public standards for the quality of medicines, foods, and dietary supplements. As USP has become increasingly active throughout the world, the need to support efforts to provide good quality medicines to everyone who requires them has become more important. CePAT is a positive step in that direction."
CePAT will provide an integrated platform of training, education, consulting and laboratory capabilities that offers a sustainable, systemic approach to medicines quality control/quality assurance 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
Follow the link for additional details on Consulting and Testing Services available.
- CePAT Program Information: Dr. Patrick Lukulay, V.P., Global Health Impact Programs, +1-301-816-8166, firstname.lastname@example.org
- CePAT Donor Information: Reema Jweied-Guegel, V.P., Development, +1-301-816-8220, email@example.com
- CePAT Materials (4–June–2014)
- U.S. Pharmacopeia Joins “Fight the Fakes” Campaign to Raise Awareness of Counterfeit and Substandard Medicines (26–Nov–2013)
- Strategic Alliance Formed to Fight Counterfeit Drugs (29–Oct–2013)
- Center for Pharmaceutical Advancement and Training Opens in Ghana (The Standard Summer 2013)
- Center for Pharmaceutical Advancement and Training Opens in Ghana (13–May–2013)
- Reducing the Threat of Counterfeits, Investing in the Future of Safe Medicines (09–April–2013)
- CePAT Announcement by Dr. Patrick Lukulay, V.P., Global Health Impact Programs (April 2012)
- Planned USP–Africa Center to Improve Quality of Medicines in Sub-Saharan Africa (The Standard, Winter 2012)