By Samwel Doe Ouma
The Kenya pharmaceutical industry regulator-Pharmacy and Poisons Board (PPB) -has received a quality management system (QMS) 9001:2015 certification of International Organization for Standardization (ISO) from Kenya Bureau of Standards.
The 9001:2015 ISO certification now makes Pharmacy and Poisons Board one of the four national drug regulatory authorities out of seven in the East African Community (EAC) to be ISO certified.
This implies that ISO certified national regulatory authorities now have standardized systems and methodologies of doing things and can get into mutual recognition of regulatory outcomes which can be used to make regulatory decisions and promote ease of doing business. It will also provide a platform for continuous improvement, and delivery of consistent and quality regulatory outcomes.
Speaking at the official hand over of the PPB 9001:2015 ISO standardization certificate on behalf of the health cabinet Secretary Sicily Kariuki, Dr.John Masabi Wekesa said that the attainment of the standardization and compliance to it will offer convenience to both international and local markets.
“PPB attainment of ISO 9001:2015 is a proof of consistency in delivery of services that meet both legal and regulatory requirements,” he said.
Fred M. Siyoi, Chief Executive officer (CEO) and Registar PPB, said the ISO standardization will not only help in enhancing PPB regulatory mandates but also in achieving efficiency in customer service delivery and promotion of both regional and international trade of pharmaceutical products, health technologies and free movement of personnel.
“The ISO 9001:2015 will help in removing trade barriers and free movement of pharmacy personnel as it was a requirement for harmonization of quality management systems within all the regulatory authorities in the East Africa Community (EAC) to ensure that the systems, products and services offered across board met regulatory requirements of other countries within the region and internationally,” he said.
He explained that PPB journey to attain the ISO certification started in 2012, with the realization that the EAC community had to standardize their regulatory roles and the only way that they could achieve a harmonized system was through attainment of ISO standard.
PPB Board Chairman, Dr. Jackson Kioko, said that the attainment of the ISO 9001:215 is major milestone in regulation as it will assure Kenyans of quality drugs, translating to improved health outcomes, quality of life and a productive citizenry.
“PPB business re-engineering started in 2010, in 2014 the quality management department was constituted with only one member of staff with an aim to establish a fully-fledged quality management and a functional registry and establish quality management systems in all the regional offices,” he said, adding that “good governance and accountability has been critical in attainment of the ISO certification.
Dr. Kioko further explained that there is need for national drug regulatory authorities to strike balance between effective regulation and access, saying that if the balance is not met it might hinder universal health coverage goals of provision of affordable, access of quality healthcare.
“We are aware that the main objective of regulation is to safeguard public health by making available safe, effective and quality essential medicines and health technologies, although we know this can slow down access we are careful as a board to strike a balance between access and regulation in order to contribute to Universal Health Coverage (UHC) goals,” he said during the launch.
Dr. Henry Rotich, Director Metrology and Testing, Kenya Bureau of Standards said that ISO 9001:2015 will enhance PPB efficiency and improve customer satisfaction and go a long way in realizing PPB vision to be center of excellence in regulation of pharmacy profession, medical products and health technologies.
“The attainment of ISO 9001:2015 is assurance that PPB will implement the regulatory measures with an aim of achieving highest standards of safety, efficacy and quality for all drugs, medical products and health technologies that are locally manufactured, imported, distributed, sold or used to ensure the protection of consumers as envisaged by laws regulating drugs in Kenya,” he said.
