Quality Management Systems
Boundaries and applicability covered in Scope
The scope of the quality management system shall cover the processes of Pharmacy and Poisons Board (PPB) at headquarters, including the following directorates; Office of the Chief Executive Officer, Corporate Services, Health Products and Technologies, Pharmacy Practice and Laboratory Services located along Lenana Road.
The Board shall meet all the requirements of ISO 9001:2015 International Standard in order to:
- Demonstrate its ability to consistently provide products and services that meet customer requirements and applicable statutory and regulatory requirements.
- 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.
- Ensure that the requirements of all relevant interested parties are met.
The Board is mandated with the following core functions:
- Ensuring the quality, safety and efficacy of medical products and health technologies
- Regulation of the training and the practice of pharmacy
- Advising the government on any matter relating to the regulation of medical products, health technologies and the profession of pharmacy
Products and services
We offer the following products and services to our clients:
- Registration of medical products and health technologies
- Control of import and export for medical products and health technologies
- Licensing of manufacturers and distributors of medical products and health technologies
- Licit control of narcotics and psychotropic substances in line with the International Conventions
- Conduct regulatory inspections of manufacturers, storage facilities and distributors of medical products and health technologies
- Conduct laboratory testing of samples collected during post market surveillance and investigations.
- Approve and regulate clinical trials on medical products and health technologies
- Regulate the promotion, advertising and marketing of medicinal substances in accordance with approved product information
- Conduct post marketing surveillance of safety and quality of medical products and health technologies
- Promotion of rational use of medical products and health technologies
- Control and supervision of disposal of pharmaceutical waste.
- Conduct Pharmacovigilance of medical products and health technologies
- Providing technical support for local manufacturing of medical products and health technologies
- Prescribe the minimum requirements and approve qualifications of persons wishing to be registered or enrolled as pharmacists or pharmaceutical technologists respectively
- Maintain a register of all persons registered or enrolled under the Act
- Prescribe and conduct examinations for purposes of recognition, registration or enrollment
- Establish/prescribe different categories of pharmacy businesses and the scope of practice of persons registered or enrolled as per the CAP 244
- Approve institutions to be established or accredited for training of pharmacists and pharmaceutical technologists
- Regulate, monitor and inspect personnel and premises that are involved in training, Continuous Professional Development and pharmacy practice;
- Licensing of pharmacists and pharmaceutical technologists and medical representatives
- Approve and license the premises for the practice of pharmacists and pharmaceutical technologists
- Establish, approve and accredited continuing professional educational programs for pharmacists and pharmaceutical technologists
- Establish and maintain a professional code of conduct for pharmacists and pharmaceutical technologists
However, the top management may periodically review the boundaries and applicability of the ISO 9001: 2015 requirements based on the size or complexity of the organization, the range of organization’s activities and the nature of the risks and opportunities.