The Pan African Health Foundation has successfully completed an evaluation by the World Health Organisation Performance Quality Safety as a manufacturer of AD syringes for immunisation and curative syringes with Reuse Prevention Feature.
The PAHF AD Syringe Manufacturing Plant is now pre-qualified, accredited and certified as a manufacturer of syringes that meet the highest international quality and safety standards, making it the first and only WHO pre-qualified manufacturer in Nigeria and the whole of West and Central Africa Region, the second company in the whole of Africa, and the 16th company in the World.
The AD Syringe are syringes that disable automatically after one use, thus preventing unsafe reuse that can spread blood-borne pathogens such as hepatitis b, hepatitis C and HIV-AIDS.
In order to achieve an effective control for intradermal, subcutaneous and intramuscular needle injections, WHO recommends the use of only single-use injection devices.
A secure and safe supply is thus essential in other to reduce the infection risks associated with the reuse of injection devices in both therapeutic and preventive health care delivery.
In 1979, the WHO, in collaboration with UNICEF, established the PQS system as a series of specification and test procedures for essential drugs, devices, cold chain equipment and other immunisation products.
Since then, the WHO PQS system has evolved and developed into the de facto international gold standard for the health care industry.
Products that conform to this specification and test procedures are listed in the WHO/UNICEF PQS System.
Also, in the quarter of the century since it was first introduced, the WHO PQS system, and its predecessor the PIS system, have become the principal source of information and advice for those responsible for purchasing products listed on the Essential Drugs List and for use in immunisation programmes.
In a statement on Saturday by the Executive Secretary of PFAF, Amenya Wokoma, the company said: “PAHF is honored to be selected by WHO as Nigeria’s first recipient of their PQS certification.
“This recognition validates the significant efforts we have put to achieve world-class quality, safety and performance, with technology and factory systems that are at the leading edge of innovation and value.
“Our company believes that such a strategic focus is fundamental to achieving the optimal combination of product performance, quality and safety for delivering the best health care value to Nigerians and other Africans.
“PAHF’s effort, as validated by the WHO, has special significance since it is wholly African led and owned.”
PAHF’s WHO PQS pre-qualification has further and very important significance when viewed in the context of the conventional wisdom which holds that Nigerian and African companies cannot become WHO PQS certified because they usually lack the skills, technology, process and scale to meet WHO’s very stringent quality standards.
Furthermore, PAHF’s WHO PQS certification gives a major practical impetus to the efforts by Nigeria to combat the counterfeit/sub-standard drugs and medical supplies epidemic.
PAHF’s WHO prequalification will also facilitate the adoption of the AD Syringe technology that meets unified standards of quality and safety in Africa by national and sub-national governments.
Wokoma’s statement further stated: “The WHO PQS award also gives validation to the Integrated Medical Industries Project, which PAHF is currently implementing in collaboration with the Rivers State Ministry of Health.
“PAHF is now encouraged to strive for excellence and continuos improvement in this landmark project which will increase our yearly production capacity to 1 billion syringes, plus 100 million IV-Giving Sets, 90 million litres of parental solutions, medications and injectables.
“When this project is completed at the end of 2013, we shall then be enabled to match our certified world-class quality with a truly fully-integrated factory of world-class scale and scope, and thus become the most valuable player in the Nigerian health care value chain.”
The PAHF was founded as an International NGO in Nigeria, the United States and the United Kingdom in 2003 to develop Africa’s local capacity by building lasting African infrastructures and facilities to produce high quality medical devices at affordable price, to help reduce Africa’s heavy.
PAHF’s first project was the state-of-the-art AD Syringe manufacturing facility in the Port Harcourt, Rivers State, Nigeria, which was built with support from and in collaboration with the Rivers State Government and the Federal Ministry of Health.
The Plant was completed in December 2008, accredited by the Pharmacist Council of Nigeria in February 2009, obtained NAFDAC registration in June 2009 and has been in commercial production since then.
Following this, PAHF’s factory obtained the ISO 13485:2003 certification in November 2010.
The company said its strategy departs from the traditional model of assisting Africa that emphasises the ad hoc donation of essential medical supplies.
In contrast, PAHF said it has adopted a unique approach of seeking to develop Africa’s local capacity by building lasting African infrastructures and facilities to produce these essential products, on a long-term sustainable basis.
The approach, it said, not only increases the availability, affordability and acceptability of essential medical technologies, it will also enable the transfer of essential technology, develop permanent local capacity and enable the achievement of global standards within Africa.
PAHF, with the sponsorship and collaboration of the Rivers State Government, has begun the implementation of a $275 million Integrated Medical Industries Project, which comprises of a one billion syringes per annum syringe plant, one billion per annum hypodermic needles plant (Africa’s first), a 105 million set per annum IV-Giving-Set Plant (Africa’s first), a 90 million litres per annum IV solutions/medication and injectables Plant, and a 14mw captive gas-fired power plant.