Quality & safety
Octapharma has an international reputation for the safety and quality of its products. We strive for the highest quality throughout the entire production process as shown below.
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We strive for the highest quality throughout the entire production chain.
At any stage in the process, a single donation can be traced.
Selection of donation centres
Inspections by Octapharma and national/international authorities
GMP* compliant
*Good Manufacturing Practice
Donor selection criteria
Health screening, medical questionnaire and blood test
Low risk for viral transmission
Absence of sexually transmitted diseases
Donation testing
Testing of each donation for:
Hepatitis A, B & C, HIV and Parvovirus B19, using a nucleic acid amplification test (NAT)
Three infectious disease markers: anti-HIV 1 & 2, anti-HCV and HBsAg
Single donation control
Registration of incoming plasma and control of documentation
Incoming plasma quarantined prior to approval for use in manufacturing
Nucleic acid amplification test (NAT) and testing of three viral markers (anti-HIV 1 and 2, anti-HCV and HBsAg) are performed for all plasma samples prior to shipment and results are verified during a single donation control step
Release of plasma for manufacturing
Performance of confirmatory testing of the plasma for manufacturing and for two viral markers (anti-HIV 1 and 2, HBsAg)
*Good Manufacturing Practice / † Good Laboratory Practice
Fractionation, visual inspection and packing
Pooling of plasma
Fractionation and purification
Virus inactivation
Two or three independent, complementary and validated inactivation steps are taken to eliminate enveloped and non-enveloped viruses
End formulation
Sterile filling, visual inspection and packing
*Good Manufacturing Practice
Manufacturing process according to GMP*
Change control, supplier approvals, inspections, education, documentation, handling of deviations, qualification and validation etc.
Quality assurance and quality control
Strict incoming goods, in-process and final product quality controls
Environmental monitoring
*Good Manufacturing Practice
Batch release
Batch quarantined until internal, national and international batch release
Distribution of finished products according to GDP*
*Good Distribution Practice
Regulatory approval of products
National regulatory authorities evaluate the safety, efficacy and tolerability of each product in a particular indications from data obtained in GCP clinical trial
Pharmacovigilance
Pharmacovigilance involves the collection, processing, management, quality control, follow-up for missing information, coding, classification, duplicate detection, evaluation and timely electronic transmission of individual case safety reports (ICSRs) from any source
Signal management
‡ Good Pharmacovigilance / § Good Clinical Practice
Pharmacovigilance involves:
Scheduling, preparation (including data evaluation and quality control), submission and assessment of periodic safety update reports
Continuous safety profile monitoring and benefit-risk evaluation of authorised medicinal products and notification of changes to authorities
Communicating information to patients and healthcare professionals about changes to the risk-benefit balance of products
Implementation of variations to marketing authorisations for safety reasons according to the urgency required