From people -
for people
Carefully Selected
Donor Centers
Selection of Healthy
Plasma Donors
High Quality
Plasma
Incoming Plasma
Control
Small Plasma
Batches
Virus Inactivation
Good Manufacturing
Practice
Quality Assurance
& Quality Control
Laboratory Batch
Release
Controlled storage
and Shipment
Clinical Evaluation
Pharmacovigilance
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Incoming Plasma Control
Incoming plasma is stored in a separate quarantine freezer until clearance. Each unit is inspected and cross-matched with its test results and shipping documents. This procedure is documented and can be traced for each single plasma unit.
Overview of the incoming control steps:
- Verification of shipping and storage conditions
- Verification of plasma documentation (test certificates, donation lists)
- 100% inspection of incoming units
- Cross-match of units and test results
- Exclusion of unsuitable units and look-back units
- Documentation of each unit related to batch
Octapharma uses separate storage facilities for un-inspected incoming plasma, for cleared plasma and for finished products.
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