ISO 9001 certification is an international standard that specifies the requirement for a quality management system.
At the presentation of the certificate in Abuja, the minister of health Dr Osagie Ehanire described the ISO 9001;2015 certification as a major achievement not only to the pharmacy Council of Nigeria but to the entire health sector, as it will enable PCN to improve on its robust regulatory activities in line with global best practices.
The Registrar of the Pharmacists Council of Nigeria, Dr Elijah Mohammed who described the attainment of ISO 9001 as historic, said the PCN over the years has made tremendous efforts to consistently improve its regulatory functions for the attainment of global best practices in pharmaceutical regulations.
“The journey to ISO 9001: 2015 certification began following the assessment visit by the World Health Organisation(WHO) to Nigeria in June 2019 for the global benchmarking exercise of Nigeria Regulatory Authority(NRA), during which it was recommended that PCN should institutionalise Quality Management System(QMS)”
Dr Mohammed said this recommendation led to the Pharmacy Council of Nigeria’s collaboration with the United States Pharmacopia/ Promoting Quality of Medicine Plus (USP/ PQM+) programme which begin in 2001.
*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, reviews and development of PCN documents and conduct of internal audit.
The PCN Quality Team led by the Quality Manager – Dr . Amina Omar and the entire Regulatory staff exhibited unparalleled commitment towards institutionalization of Quality Management System(QMS) in PCN. The Certification audit was later carried out in December, 2021 by NECA’s Global Certification, after which the Council was found to be in accordance with the requirements of ISO 9001; 2015 Quality Management System Standards”
The Registrar stated that the council had already put machineries in place to ensure that PCN sustains the status of ISO 9001, by integrating its processes and procedures to the requirements standards, to ensure that it achieved its mandate of providing quality pharmaceutical products and services for sustainable health care delivery.
Also speaking at the occasion the Chairman House Committee on Health Mr. Tanko Sununu said the achievement shows the seriousness Nigeria Government places on quality and safety and called on PCN to ensure that the certification reflects on good pharmaceutical practice in the country.
In a remark, the Senior Vice President of Global Public Health of United States Pharmacopeia(USP) Dr Emily Kaine said the PCN certification shows regulatory maturity and institutionalisation of standards.
For the President Pharmaceutical Society of Nigeria, Prof Cyril Usifo, the celebration was kudos to the Pharmacy Profession and the entire health sector, urging the PCN to sustain the ISO 9001; 2015 status, through robust regulatory activities.
The Director-General of the National Institute for Pharmaceutical Research and Development NIPRID, DR Obi Adigwe said the PCN ISO 9001; 2015 certification was a means to achieving medical security for Nigerians.
According to Dr Adigwe, unless Nigeria was able to manufacture most of the medicines consumed in the country, it will always fall victim to medicine insecurity.
The entire process of PCN ISO 9001: 2015 Certification was supported and funded by the United States Agency for International Development USAID through United States Pharmacopeia Promoting Quality of Medicines plus.( PQM+) programme.
The Head Research and Statistics of the PCN, Dr Ibrahim Babashehu Ahmed Thanked USAID for its support in achieving ISO 9001 certification and promised to maintain quality and standard through training and retraining of its staff
Reporting by Maureen Eke, editing by Daniel Adejo.