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Quality medicines: PCN gets ISO 9001 certification

By Hassan Zaggi

The efforts by the Federal Government to ensure that Nigeria attains high standard in quality medicines has gotten a boost as the Pharmacists Council of Nigeria (PCN), on Thursday, received ISO 9001:2015 Certification.

The PCN is a Federal Government -owned parastatal charged with the responsibility of regulating and controlling pharmacy education, training and practice in all its aspects and ramifications including regulating Pharmacy Technicians and Patent and Proprietary Medicines Vendors (PPMVS).

Speaking at the ceremony in Abuja, the Minister of Health, Osagie Ehanire, applauded the PCN for attaining the ISO 9001:2015 certification status, describing it as  a big achievement for Nigeria.

The Minister said that the attainment of the  ISO 9001:2015 status will enable PCN to improve on its robust regulatory system, encourage dynamism and  ensure that it is at par with other pharmacy regulatory authorities across the globe

“Let me use this opportunity to thank USAID and USP/PQM+ for their commitment towards strengthening regulatory agencies under the health sector in Nigeria which eventually would lead to improved health status of the Nigerian populace.

“I also want to appreciate the Registrar of the PCN and his team for their hard work and doggedness in achieving this great feat within a short period,” the Minister said.

On her part, the Senior Vice President, Global Health and Manufacturing Service (GHMS), United States Pharmacopeia (USP), Emily Kaine, explained that the ISO 9001 is an internationally recognized certification that reflects PCN’s commitment to building strong management systems, ensuring consistent and transparent processes, procedures, and continuous improvement.

According to her, achieving the ISO 9001 was an important step in the recent attainment of World Health Organisation  (WHO) Maturity level 3 by PCN and NAFDAC.

While saying that PCN plays a vital role  in ensuring the health of patients, she noted that “Pharmacies, in all forms, are often at the very frontline of patient care – meaning they may be the first place a patient approaches in the case of illness, as well as a consistent resource for ongoing access to treatments.”

Earlier, in his address of welcome, the  Registrar of the Parmacists Council of Nigeria, PCN, Pharm. Elijah Mohammed,  explained that, over the years, PCN has made tremendous effort to consistently improve on its regulatory functions for  the attainment of global best practices in pharmaceutical regulations.

He, however, assured that PCN has put  in place modalities  to ensure that it complies with the ISO 9001:2015 requirements.

Mohammed recalled that: “The journey to ISO 9001:2015 certification began following the assessment visit by WHO to Nigeria in June 2019 for global benchmarking exercise of Nigeria Regulatory Authority (NRA), during which it was recommended that PCN should institutionalize Quality Management System (QMS).

“The PCN collaboration with USP/PQM+ programme began in 2021. This collaboration necessitated the need to conduct a baseline assessment of the PCN Head office/ Registry with respect to the requirements of ISO 9001:2015 standards.

“This was followed by series of capacity building, review and developments of PCN documents and conduct of internal audit.”

He further disclosed that the PCN has integrated its processes and procedures to the requirements of ISO 9001:2015 Standards, in order to ensure that it delivers its mandate in a sustainable manner and continue to ISO 9001:2015 compliant.

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