FG: We’re overwhelmed with joy/of

By Joseph Erunke

ABUJA-THE Pharmacists Council of Nigeria,PCN, has received global certification on quality management systems by NECA’s Global Certification Limited,a first indigenous certification body in Nigeria to provide certification and training services for companies locally and internationally.

The organisation, charged with the responsibility of regulating and controlling Pharmacy education, training and practice in all aspects and ramifications in Nigeria, received the ISO 9001:2015 certification, Thursday,in Abuja.

This came just few days after the National Agency for Food and Drug Administration and Control, NAFDAC, received  the World Health Organisation,WHO’s Maturity Level 3 status, giving it the status of its approved products to be traded internally.

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The ISO 9001: 2015 is  an internationally recognized standard for Quality Management Systems,QMS. It is the most widely used QMS standard in the world, with over 1 million certificates issued to organizations in 178 countries. 

ISO 9001:2015 specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

By receiving ISO 9001:2015 certification,the PCN has  entity right to  meets global standards for pharmacy regulation to the satisfaction of stakeholders.

Reacting to the development,the federal government said it was overwhelmed with joy, thanking the United States Agency for International Development,USAID,which it said the get couldn’t have been achieved without it.

“This great achievement was recorded through the support of United States Agency for International Development, USAID, through United States Pharmacopeia,USP/Promoting Quality of Medicines Plus,PQM+.

“The quest of  management of PCN to improve on the regulatory mandate of the Council which aligns with the recommendation of the World Health Organisation,WHO during the National Regulatory Authority,NRA Global benchmarking exercise of PCN and NAFDAC triggered the PCN to embark on on the journey implementation of Quality Management Systems,Q.mS I’m its regulatory operations.

“The attainment of of ISO;9001 2015 could not have been swiftly achieved without the strong collaboration with the USP/PQM+ funded by USAID,”Minister of Health,Osagie Ehanire, who, was a chief host at the event,said.

He added:”The Federal Ministry of Health recognise that the attainment of ISO 9001:2015 by the PCN is a major achievement for the Nigerian health sector as it will enable PCN to improve on it robust regulatory system, encourage dynamism, reproductivity of its processes and procedures while ensuring that it is at par with other pharmacy regulatory authorities across the globe.”

Earlier,in his welcome address at the event,where he received the ISO 9001:2015 certificate on behalf of his organisation, the Registrar of PCN, Dr  Elijah Mohammed,said the certification was a great feat not only for the PCN but for Nigerians as a whole.

Açcording to him,the ISO Certification guarantees the PCN  entity right to  meets global standards for pharmacy regulation to the satisfaction of stakeholders.

Hear him:”The attainment  of the  ISO 9001:2015 is a great milestone not only to the PCN but to Nigeria at large.  With this certification, there is going to be improved service delivery by the PCN, key stakeholders and ultimately it will benefit the Nigerian people, most especially patients who are going to be on the receiving end of the services.

“With this, we have been empowered with more ideas on how to carry out regulatory functions.

“Also, processes have been put in place to enable us go into the field to carry out enforcement. This is to ensure that Nigerians have quality products and services. This will also enable us to efficiently check mate individuals that are not doing the right thing.

“Plans are already in place to visit relevant agencies to see how we we encourage individuals and companies to look inward in the Pharmaceutical products locally. Most of the raw materials are imported. We want to ensure that the ingredients are produced locally. This will also boost the local market”, he said.

Açcording to him,PCN has  made tremendous effort over the years to consistently improve on its regulatory functions for attainment of global best practices in pharmaceutical regulations.

 “The journey to ISO 9001:2015 certification began following the assessment visit by World Health Organization (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. The PCN Quality Team ably led by the Quality Manager – Dr. Amina S. Omar and indeed the entire Registry staff exhibited unparalleled commitment towards institutionalization of QMS in PCN.

“The certification audit was later carried out in December, 2021 by NECA’s Global Certification Ltd, after which the PCN Head Office/Registry was found to be in accordance with the requirement of ISO 9001; 2015 Quality Management Systems standards.

“The entire process was supported and funded by the United States Agency for International Development (USAID)”,he said.

On his part,the USAID Mission Director, Ann Patterson,said she was grateful that her organisation has supported the Pharmacist Council of Nigeria to attend the internationally- Recognised International Organisation for Standardization Certificate.

The achievement,she explained, would improve the quality of Nigeria’s health system and save the lives of millions of Nigerian’s, especially women and children. 

The PCN certification,he said,”will also strengthen the partnership between USAID and Nigeria to streamline modernize health intervention and services.”

He spoke further:“USAID has been strengthening medicine quality Assurance system and regulatory functions in Nigeria since 2013. These support has led directly to the international accreditation of five medicine quality laboratories in Lagos, Anambra, Kaduna state and the Federal Capital Territory . 

“ USAID, through promoting the quality of Medicine Plus Project, has worked closely with the pharmaceutical manufacturing sector in Nigeria for many years to increase the availability of quality medicine for maternal and child health for example, malaria medicine. These has ensured that manufacturing processes are with international best practices. This support will help eliminate substandard  counterfeit medicine from the Nigerian market.”