Meeting the demands of the global marketplace
Quality management policies which are implemented and followed by PHARMAKINA comply with the requirements of the WHO Good Manufacturing Practices (GMP) as required by the National Health Ministry of the DR Congo.
The Quality assurance, quality control and production services are the integral and separate part of the Pharmaceutical Department placed under legal responsibilities of the Titular Pharmacist.
Under this system:
- Building facilities, water supply system, HVAC system are validated;
- Equipment is calibrated and/or qualified;
- Manufacturing processes are qualified;
- Raw material, intermediate products, packaging material and finished products are controlled;
- Finish product quality is certified with reference to BP/Eur.PH pharmacopoeia requirements;
- Each batch produced by PHARMAKINA is inspected, sampled and tested according to standard operating procedures. A batch record is therefore set up and submits for batch release certification. Only approved finished products are released for sale.
A GMP self-inspection(internal audit) program is implemented in PHARMAKINA for monitoring its quality system activities and therefore to ensure the continuous compliance with the WHO-GMP requirements and standard operating procedures on the site. These internal audits are conducted by the Quality Assurance Manager. Since 2001, several inspections have been performed in PHARMAKINA production facilities by external auditors: customer inspectors, NGO consultants and various governmental regulatory bodies.