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.

We strive for the highest quality throughout the entire production chain.
At any stage in the process, a single donation can be traced.
1. Ensuring quality in the plasma donation process

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
2. SDC

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 

3. Quality control

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

4. Quality Management System

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 
5. Quality in 
clinical use

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