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Nigeria Can Now Approve Drugs for Global Use, Says Orhii

Nigeria Can Now Approve Drugs for Global Use, Says Orhii

NafdacThe National Agency for Food and Drug Administration and Control (NAFDAC) has now been authorised to

test all medicinal products submitted for regulatory actions and investigations, as well as approve those that meet global standards.
This was made known by the Director General of the
agency, Dr. Paul Orhii, during the official presentation of the certificate of accreditation of the Central Drug Control Laboratory (CDCL)presented by the Vice President, Global Health Impact Programmes, United States Pharmacopoeia, (USP) Dr. Patrick Lukulay, in Lagos, recently.
According to Orhii, the accreditation means CDCLis the first government medicine laboratory to attain ISO/IEC 17025:2005 accreditation in Nigeria, hence, the laboratory would therefore provide assurance to Nigerian pharmaceutical industry, development partners and other stakeholders that NAFDAC is competent to test both locally manufactured and imported pharmaceutical products.
He explained that with this accreditation, the CDCL has now attained both national and international recognition, thereby promoting patronage and economic benefits to both NAFDAC and Nigeria at large. “This accreditation will give assurance to pharmaceutical companies coming to our laboratory that test results are obtained using properly validated and calibrated systems by staff with the right expertise, which therefore offers confidence to customers on the reliability of analytical services provided by CDCL.” “As you are all aware, the issue of fake, counterfeit, spurious and substandard medicines has been a great challenge to the pharmaceutical industry and the general populace as million of naira and thousands of lives are lost because of this scourge. However, the ISO accreditation has added another strong tool that will help in making secure
and reliable pronouncement on medicine within the
country,” he said. The DG who was visibly excited, said the pronouncement will also help the pharmaceutical inspection cooperation scheme to build confidence in NAFDAC as a regulatory partner not just in inspection programs but in producing accurate and reliable results for medicines. Speaking further, he said, “hence forth, our CDCL will serve as a good reference laboratory for the pharmaceutical industries seeking World Health Organization product and manufacturer pre-qualification since the laboratory test results will be globally acceptable. “Today, NAFDAC adds another feather to her cap with accreditation of the laboratory. We strongly believe in an objective, scientific and factual system, with strong conviction in minimal human interference in the regulatory testing systems and have continued to encourage, support
and drive the accreditation programme of NAFDAC
laboratories.” Orhii explained that the hard work of the agency is evident in the quick successive accreditation of the Pesticide Residue, Mycotoxins and Proximal Analysis Laboratory units in the central laboratory, in Oshodi and now the drug laboratory, thus ensuring that Quality Management System
(QMS) is being entrenched in the processes. While explaining the preparations of the agency so far in actualising the feat, Orhii said, “the pursuit of this
laboratory accreditation started in June, 2013 with the
assessmentof the laboratoryQMS by theUSP sponsored by the United States Agency for International Development (USAID). “The process of getting this accreditation however continued with strengthening the laboratory capacity through technical and material support, equipment calibration, as well as support for participation in proficiency testing. These enormous support and collaboration resulted in the accreditation ceremony witnessed today. “The test scope under this accreditation is inclusive of high pressure liquid chromatography, spectrophotometry, dissolution, uniformity of dosage units, neutroceutical products, among others.” Orhii requested assistance from USP and USAID in creating massive intensive public awareness on the use of mobil
Source: Thisday

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