AROUND THE WORLD SUCCESS STORIES Strengthening AU–PANVAC’s capacities
The African Union Panafrican Veterinary Vaccine Centre (AU–PANVAC) was strengthened as part of the second component of the VSPA project, in order to ensure the production and use of high-quality PPR vaccines in Africa, in compliance with international standards.
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Objectives
The expected results are as follows: reliable PPR vaccine quality control is provided; vaccine production laboratories produce high-quality PPR vaccines; PPR vaccine quality is monitored at different levels (primary and secondary storage in producing countries, secondary and tertiary storage in importing countries, and in the field prior to administering vaccine to animals).
With AU–PANVAC (1) playing the central role, the issues addressed were related to vaccine certification, support for producing laboratories and quality control support throughout the production and delivery chain [1]. These issues included many aspects, particularly with regard to the stakeholders involved on a continental (regional economic communities [RECs], African Union Inter-African Bureau for Animal Resources [AU–IBAR]), national (laboratories and Veterinary Services, private actors, etc.), and international (international organisations) level. Vaccination registration issues and the need for harmonisation were also addressed.
Implementation
The activities included recruitment, training and new equipment purchases at AU–PANVAC’s Headquarters (Bishoftu, Ethiopia), strengthening the capacities of PPR vaccine producers to produce good-quality products through field missions, and appropriate training sessions in the ten vaccine-producing laboratories concerned (2). They also included field missions during vaccination campaigns in various African countries (3) and coordination meetings attended by representatives of all members of the producing laboratory network (managed by AU–PANVAC).The conclusions of component 2 of the VSPA project represented a major contribution on the part of AU–PANVAC to preparing the Global Strategy for the Control and Eradication of PPR
A ‘Quality control strategy for PPR vaccines produced in Africa’ [1] was prepared, which includes the definition of quality control procedures for PPR vaccines in Africa. This strategy defines all the steps to be undertaken regarding the shipment, customs clearance, reception, testing and certification of PPR vaccine samples at AU–PANVAC and it also addresses vaccine registration issues and the need for harmonisation. It clarifies the roles and commitments of all stakeholders (4), taking into account the legal, regulatory and institutional framework for their activities, and the tools available (vaccine, tests, standards, post-vaccination monitoring tool, etc.).
Through its vaccine quality assurance systems, AU–PANVAC plays a pivotal role in facilitating the adoption of improved methods for the production and quality control of priority vaccines in Africa. It also provides free quality control for African Union (AU) member states.
National Veterinary Services and animal health practitioners must provide quality immunisation services, in other words use a vaccine whose quality control has been certified by AU–PANVAC and ensure that the cold chain is respected from storage to field. AU-IBAR and RECs, along with international organisations, will promote the use of PPR vaccines whose quality control has been certified by AU–PANVAC and these vaccines will be included in all specific tenders.
Finally, along with AU–IBAR, AU–PANVAC helped to draft a scientifically sound African Union programme for the progressive control of PPR in Africa [3]. The conclusions of component 2 of the VSPA project represented a major contribution on behalf of AU–PANVAC to preparing the Global Strategy for the Control and Eradication of PPR [2].
A Delegation from NYANSAPO College Ghana Visits AU-PANVAC
On Friday the 17th of May 2019, AU-PANVAC received a delegation of Diplomats from NYANSAPO College of Ghana. The team was led by H.E Ambassador Nana Bema Kumi, Vice Rector, in their effort to learn more about the activities of the African Union’s specialized agencies such as AU-PANVAC.
On Behalf of the Director the visitors were received by Dr. Bodjo( the officer in charge) who made a presentation on the activities carried out by AU-PANVAC, followed by a visit to the center’s premises and ending with refreshments.
Ethiopian National Accreditation Office (ENAO) Conducts Audits on AU-PANVAC Staff
Thursday May 16, 2019 marks another important date at AU-PANVAC as a team of External Auditors arrived the Premises from the Ethiopian National Accreditation Office (ENAO) to conduct a Mandatory Audit with the objective;
To conduct a reassessment of the continuity and sustainability of the Quality Management System and Competency of the Laboratories. As referenced under the ISO/IEC 17025:2017 Standard.
The Assessment Criteria included; ISO 17025, AU-PANVAC Laboratory Policies and Procedures, ENAO and ILAC Requirements.
In conclusion, the Successful Audit of May 16 confirms that, the Laboratory Activities and Practices at AU-PANVAC fully meet the ISO/IEC 17025 Standard.
AU-PANVAC CELEBRATES THE ARRIVAL OF A BRAND NEW TRUCK FOR VACCINE CLEARANCE !!
The newly acquired Toyota Pickup Arrived at the AU-PANVAC Premises on the 7th of April 2019. It was warmly received by All AU-PANVAC staff, a ceremony Chaired by Dr. Nick Nwankpa, the Director of AU-PANVAC. Who indicated that the addition of the car to the already existing fleet, would not only speed up the vaccine clearance process but also improve the overall efficiency and effectiveness of the Vaccine quality Control process at the institution.
THE HAND OVER CEREMONY OF THE BASIS OF DESIGN FOR THE NEW AU-PANVAC LABORATORY FACILITY
Addis Ababa, Ethiopia- 3rd April 2019 – A handover ceremony was held today at the African Union Commission (AUC) Headquarters for the Basis of Design (BOD) for the new AU-Pan African Veterinary Vaccine Centre (AU-PANVAC) laboratory facility. United States of America’s Ambassador to the AU, H.E. Mrs Mary Beth Leonard, handed over the BOD to African Union Commission AUC’s Commissioner for Rural Economy and Agriculture, H.E. Amb. Josefa Sacko.
AU-PANVAC is presently the only Organization mandated by the AU to provide International Independent Quality Control of all vaccines used in Africa and in addition, have the mandate to produce and distribute essential biological reagents for the surveillance and diagnosis of animal diseases. Presently PANVAC operates from laboratories inherited from the Ethiopian Government in the seventies and scattered within the National Veterinary Institute facility. The establishment of a new laboratory for AU-PANVAC to be based in Debre-Zeit, Ethiopia, is expected to consolidate all the activities of the Centre at one site and ensure that these activities are implemented according to best practices and in a safe and secure manner. The new facility will include the Continental Vaccine Bank, Quality Control Unit, Biological Reagent Production facility and a Training Centre amongst others.
Speaking during the handover ceremony, H.E Amb. Sacko acknowledged the huge support provided by the US Government through its Biological engagement Program, part of the US Defense Threat Reduction Agency (DTRA); to the African Union through AU-PANVAC and indicated that the handover was the result of the transformative power of partnership between the AUC and the US Government.
She highlighted the fact that AU-PANVAC is only one of four global rinderpest holding facilities and the only one to hold both materials and emergency preparedness vaccines. She thanked the US Government for its commitment towards global security and poverty alleviation in Africa and for the initiative to provide the design for the laboratory.
“The new laboratory facility will enable AU-PANVAC to perform its activities according to international standards and best practices,” Commissioner Sacko said. “Our dream is to see DTRA assume responsibility for constructing the new laboratory as one of their continental projects as this will ensure that the project is built to specification.”
H.E. Mary Beth Leonard said, “The US’s Biological Threat Reduction Program, has been very glad to partner with AU-PANVAC as it continues through this process to design and construct a new facility, particularly to lend our expertise to ensure a safe and secure facility and procedures.”
She emphasized the importance of AU-PANVAC’s role as the African Union’s premier veterinary vaccine center that is internationally recognized and serve as the continent’s “Rinderpest Holding Facility.”
H.E Leonard further assured AU-PANVAC of continuous support to the institution during the building process.
Also present at the ceremony were; the Director AU-PANVAC, Dr. Nick Nwankpa; Dr. Charles Bodjo, the Biological Reagent Production Officer and other technical staff of AU-PANVAC. On the US Ambassadors team were Dr. Larry Smith, the Regional Coordinator for the US Biological engagement programme under the DTRA; Dr. Susan Boggs, the Global Chemical and biological Expert on Security from the Sandia Laboratories in the United States, Mr Warren Hendrickson, The Laboratory Design Architect of HDR Inc (HDR is an architectural, engineering, and consulting firm based in Omaha, Nebraska, United States), Mr. Mohammed Raja the DTRA Program specialist in Addis Ababa and Ms. Rebecka Chall , Political and Economic Assistant USA-AU.
For further information:
Dr. Nick Nwankpa,
Director AU-PANVAC
NickN@africa-union.org/nicknwankpa2004@yahoo.com
Communications Contact:
Ms. Carol Jilombo
Jilomboc@africa-union.org
Directorate of Information and Communication | African Union Commission I E-mail: DIC@africa-union.orgI Website: www.au.intI Addis Ababa | Ethiopia
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AU-PANVAC, laboratory management system ISO/IEC 17025: 2017!!
One of the important Core Values upheld at AU- PANVAC as an organisation is the continuous capacity building of staff personnel through trainings, workshops and seminars among others. It is in this regard that Eight AU-PANVAC Staff, were trained on the new version of the ISO/IEC 17025 standard, ISO/IEC 17025: 2017 from 15thto 17thJanuary 2019 by the African Quality Control Consulting PLC at AU-PANVAC, in Debre-Zeit.
AU-PANVAC is already accredited for ISO/IEC 17025:2005 by ENAO Ethiopia in November 2018 for five laboratory tests with the scope of the accreditation being “Provision of Quality Control Service for PPR Vaccine and the tests specifically includes; Peste des Petits Ruminants (PPR) Identity test by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), PPR Potency test by Cell culture technique, Freedom from mycoplasma contamination by classical PCR, Freedom from Bovine Viral Disease (BVD) contamination by Real Time PCR, and freedom from bacteria/fungi contamination by media culture technique”.
The existing ISO/IEC 17025:2005, was revised in 2017 to reflect the latest changes in the market conditions and laboratory technology trends. It also takes into consideration the latest version of ISO 9001, ISO 9001: 2015, on quality management. It is worth noting that AU-PANVAC is also Certified for ISO 9001: 2015 for Vaccine Quality Control. This training on ISO/IEC 17025:2017 is therefore aimed at familiarising and improving the staff capacity on the new version in order to create a smooth transition from the old to the new; since AU-PANVAC is required to update its accreditation to the new version by the end of 2019.
The ISO/IEC 17025 accreditation is the most important standard for calibration and testing in laboratories worldwide. For any laboratory to be ISO/IEC 17025 accredited it must demonstrate technical proficiency in producing precise, accurate tests and calibration results. Even though this is a voluntary, third party-reviewed process which ensures that a laboratory’s quality management system is thoroughly evaluated on a regular basis to guarantee continued technical competence, it is a requirement and mandatory for any laboratory wishing to maintain compliance with International standards.
A Joint Mission to AU-PANVAC by Representatives of IRED and SOPIVAT
A joint mission to AU-PANVAC was conducted by the general director and the head of vaccine service IRED, Dr. Mahamat Moussa Yacoub and the President of the wholesalers’ association and Director General of SOPIVET company in Chad, Dr.Tahir Hamdam Alfil. IRED is the National Veterinary Vaccine Production laboratory while SOPIVET is a veterinary input distributor services in Chad.
The two held discussions with the director of PANVAC on support to AU Member States on the use of good quality vaccines for the eradication of animal diseases. The team informed the PANVAC Director that a major requirement for the use of Veterinary vaccines in Chad is the provision of PANVAC’s certificate of analysis for every batch of vaccine used. They expressed their satisfaction with the services provided by PANVAC and promised to support the activities of PANVAC in Chad. The Director PANVAC on his part thanked the team for the visit and assured them of PANVACs determination to continue to support Chad in building capacity for the production and use of good quality vaccines. The Director applauded the efforts of the Government of Chad working together with the private sector to ensure that only good quality vaccines are used in the Country. The director indicated that the system put in place by Chad if emulated by other countries will contribute immensely towards controlling most of the animal diseases currently ravaging Africa. At the end of the visit, the Director presented souvenirs of PANVAC to the team.
ISO/IEC 17025 Accreditation Certificate
In compliance with International Standards and in recognition of its capacity and expertise in Vaccine Quality testing, AU-PANVAC was conferred with the ISO/IEC 17025 Accreditation (Field of Veterinary vaccine testing) by the Ethiopian National Accreditation Organization (ENAO) in 2018. This is in addition to the earlier Certification for ISO 9001: 2015 in Quality Management System which AU-PANVAC secured from DQS Ethiopia. This recognition including the previous ones by the OIE and FAO (Reference laboratory for vaccine Quality Control) places AU-PANVAC globally as a world class laboratory
Vaccine Production and Quality Assurance – Master Trainers course
Newcastle disease (ND) is the scourge of village poultry flocks throughout the developing world and has been identified as one of the major constraints to village poultry production in Africa. Vaccination is a key tool in the control of ND, however, it is costly, complex and challenging to implement effective, sustainable vaccination programs.
Sustainable ND control relies on the timely implementation of activities by well-trained and appropriately resourced personnel. AU-PANVAC together with Kyeema Foundation conducted a Pre-test of the Newcastle disease vaccine production and quality assurance courseat the AU-PANVAC facilitiesin DebreZeit, Ethiopia from 5 to 13November 2018. The purpose of course was to evaluate the training module and also provide participants with the knowledge and skills they need to:
• Plan, implement, evaluate and report on training in ND I-2 production and testing in countries that will embark on the vaccine production;
• Plan and implement laboratory trials of the vaccine;
• Oversee stability testing of the vaccine;
• Plan, implement, evaluate and report on training in cold chain management;
• Assist partner countries with vaccine registration, in particular giving guidance on Good Manufacturing Practice (GMP) and assisting with preparation of dossiers for registration;
• Plan and monitor vaccine production and testing (helping labs to identify strong points, weaknesses, opportunities and obstacles); and
• Undertake audits of vaccine production and testing.
A total of 10 participants drawn from 10 African countries, namely Ethiopia, Ghana, Kenya, Madagascar, Malawi, , Nigeria, Tanzania, Uganda, Zambia and Zimbabwe participated in the training. Mentors were from Kyeema Foundation (Australia), Mozambique and AU-PANVAC.
Veterinary Vaccine Quality Control Unit
Vaccine Quality Control Unit mandates
As part of its Mandate, the Vaccine Quality Control Unit provides International Independent Quality Control of Veterinary vaccines produced in Africa and those brought into Africa; Facilitate the standardization of veterinary vaccines production and harmonization of their quality control techniques in Africa; Promote the transfer of appropriate vaccine production technologies in Africa and also Provides training and technical support services to veterinary vaccines and quality control laboratories as part of its core mandates.
Quality Control (QC) Laboratory
The Quality Control Laboratory is divided into the following sections:
- Bacterial Vaccines QC laboratory
- Viral Vaccines QC laboratory
- Media preparation Laboratory
- Tissue Culture laboratory
- Vaccine Seed Repository Room
- Stores
- Wash up section
- Laundry section
- Decontamination Room
- Shower and Rest Room
Biological Reagent Production Unit
The activities carried out by the Biological Reagent Production (BRP) Unit are related to the following two mandates of AU-PANVAC:
- Produce and distribute essential biological reagents for animal disease diagnosis and surveillance
- Provide training and technical support services to veterinary vaccines and quality control laboratories
Facilities
Biological Reagent Production (BRP) Unit activities are carried-out using the following facilities:
- BRP Laboratory
- Molecular biology Laboratory
- Laboratory Animal facilities
BRP labratory
A specific laboratory is dedicated for BRP-Unit activities. This laboratory is divided into eight sections:
Freeze drying section (Figure 8
Fig 1: Culture and storage of Non-infected cells section.
Micro biology
Molecular biology section (Figures 9. and 10) equipped for PCR techniques (classical and Real-Time PCR) and recombinant protein characterization (Protein electrophoresis and Western Blot) is used by the two units, BRP Unit and Vaccine Quality Control Unit:
