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Good Manufacturing Practise (GMP)
High quality is critical for all plasma derivative products. This can only be achieved through a complete and integrated system of quality management covering all aspects that individually and collectively influence their manufacture. Octapharma operates in strict accordance with such a quality system and adheres to both GMP and cGMP.
All elements of Good Manufacturing Practice following national and international regulatory guidance are established. The major elements are: Change control, supplier qualification and auditing, self inspection program, training, documentation, annual product review, OOS and deviation management, qualification/validation, calibration, preventive maintenance.
Current Good Manufacturing Practice (cGMP) as the name implies is not static and reflects a commitment to adapt quality standards to the most current information, technology and practices. What is current today is not necessarily current tomorrow.
In response to these requirements Octapharma continuously updates and improves its facilities, equipment, systems and technical measures, applies ever increasing restrictions for plasma donors, implements additional testing on donor plasma and continuously invests in the viral removal / inactivation capacities of manufacturing processes.
Implementation of these standards raises the bar for other manufacturers and ensures the continued enhancement of cGMP.
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