Quality Assurance covers all matters that individually or collectively influence the quality of the product, and incorporates current Good Manufacturing Practice (cGMP).
The Octapharma Quality Assurance System ensures that:
- Medicinal products are designed, developed, produced, controlled, stored and distributed in a way that takes account of cGMP and Good Distribution Practice (GDP) requirements.
- Management and organization responsibilities are clearly specified. All employees are trained in cGMP, GDP, process knowledge, and within their areas of responsibilities and duties.
- Production and control operations are clearly specified using defined and validated procedures.
- All necessary controls on intermediate products, and any other in-process controls, are carried out.
- Facilities, equipment and supervision systems are certified, controlled and maintained.
- Suppliers of raw materials and packaging material including any outsourced activity, are regularly audited and evaluated.
- Raw materials are only released and used in manufacturing processes after the satisfactory completion of an evaluation by the Quality Unit.
- Deviations from established procedures are documented and investigated, and corrective/preventive actions are performed.
- Octapharma’s Change Control System manages changes that affect product quality.
- The final product is reviewed and assessed, according to defined release procedures.
- Medicinal products are not sold or supplied before a qualified person has certified that each production batch has been produced and controlled in accordance with the requirements of the appropriate national marketing authorization and any other government regulations relevant to the production, control and release of medicinal products.
- There is a procedure for self-inspection and quality audits, which regularly appraises the effectiveness and applicability of the Quality Assurance System.
- There are formal systems in place for the periodic review of operation of the Quality Assurance System and to identify opportunities for continual improvement. Quality Risk Management Principles are applied to all activities that require evaluation of any risks and impacts on other related operations and to mitigate the risks.