PCN Bags International Certification in Pharmacy Regulatory Standards

Onyebuchi Ezigbo

The  Pharmacy Council of Nigeria (PCN) has attained the ISO-9001:2015 Quality Management Standards Certification for the regulation of drug manufacture and distribution in the country. 
Speaking on the significance of the achievement, shortly after the Public presentation ceremony of ISO 9001:2015 Certificate issued to the PCN by NECA’s Global Certification Limited in Abuja, the Registrar of PCN, Dr. N.A. Mohammed said that ISO-9001:2015 international certification will establish credibility and trust between customers and stakeholders and other business partners. 

“In this case this ISO-9001:2015 certification guarantees identity for PCN over pharmacy regulations to the satisfaction of stakeholders,” he said. 
Mohammed said PCN had over the years strived to improve standards in pharmaceutical practice in the country in keeping with its mandate.

According to him, the journey towards the attainment of the ISO certification began following the assessment visit of the WHO officials in 2019 for global bench marking exercise for Nigerian regulatory authority during which it was recommended should institutionalise quality management systems. 
He said that the actual process towards attainment of the certification began in 2021 through PCN collaboration with USP when a base line assessment of the PCN facilities was conducted.
He also said that there were series of capacity building to improve  quality documentation of  processes.
“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 said.
The Senior Vice President, Global Public Health, United States Pharmacopoeia (USP), Emily Kaine said the attainment of the international certification of ISO – 9001-2015 by PCN demonstrated it’s strong commitment to maintaining strong management systems and ensuring that right processes are maintained. 

She also said that the attainment of the ISO- 9000 was also instrumental to the recent Level 3 certification granted to  National Agency for Food Drug Administration and Control (NAFDAC), adding it would ensure that Nigeria has access to quality medicines and health services.