Quality Assurance
At BPL, we follow strict processes of rigorous checks and testing before we release any of our products for use in patients. This is in addition to only using licensed approved suppliers.
Approved Plasma Suppliers
At the beginning of 2003, the Department of Health purchased Life Resources Incorporated, licensed by the FDA.
At the beginning of 2003, the Department of Health purchased Life Resources Incorporated, licensed by the FDA.
Selected Donor Centres
BPL uses plasma collected at 24 centres, all licensed by the FDA, approved by ABRA and audited by the MHRA.
BPL uses plasma collected at 24 centres, all licensed by the FDA, approved by ABRA and audited by the MHRA.
Donor Screening
All potential plasma donors have their identities confirmed and have to pass at least two donation screens before acceptance. Each donor is interviewed on lifestyle and health history at the time of every donation.
All potential plasma donors have their identities confirmed and have to pass at least two donation screens before acceptance. Each donor is interviewed on lifestyle and health history at the time of every donation.
Donor Deferral
In the USA, the National Donor Deferral Registry (NDDR) allows donor deferral information to be shared on a confidential inter-company basis. The NDDR prevents someone deferred at one centre from donating at another or excludes them from
re-donating.
In the USA, the National Donor Deferral Registry (NDDR) allows donor deferral information to be shared on a confidential inter-company basis. The NDDR prevents someone deferred at one centre from donating at another or excludes them from
re-donating.
Regular Donation by Apheresis
Donors are encouraged to donate regularly, resulting in frequent virus testing and review of post-donation information. Full traceability to individuals is assured.
Donors are encouraged to donate regularly, resulting in frequent virus testing and review of post-donation information. Full traceability to individuals is assured.
Individual Donor Testing
All serological test are approved by the FDA and no virus positive donations are used.
All serological test are approved by the FDA and no virus positive donations are used.
Minipool Testing
Even though there are steps in the production process specifically aimed at virus reduction/elimination, independent minipool testing for HIV, HBV, HCV, HAV and Parvovirus B19 by NAT/PCR is also performed. No donation identified as positive by PCR is included in the fractionation pool.
Even though there are steps in the production process specifically aimed at virus reduction/elimination, independent minipool testing for HIV, HBV, HCV, HAV and Parvovirus B19 by NAT/PCR is also performed. No donation identified as positive by PCR is included in the fractionation pool.
Fractionation by BPL at Elstree
Individual donations are pooled at BPL for fractionation by well established processes according to Good Manufacturing Practice (GMP) standards. This ensures products are manufactured to specific and consistent protocols.
Individual donations are pooled at BPL for fractionation by well established processes according to Good Manufacturing Practice (GMP) standards. This ensures products are manufactured to specific and consistent protocols.
Virus Inactivation / Removal
BPL employ a variety of tried and tested inactivation and removal procedures.
BPL employ a variety of tried and tested inactivation and removal procedures.
Quality Assurance for Final Product
Product is only released for sale once all details have been checked and verified by qualified personnel. The National Institute for Biological Standards and Control (NIBSC) also undertakes testing of each batch prior to release.
Product is only released for sale once all details have been checked and verified by qualified personnel. The National Institute for Biological Standards and Control (NIBSC) also undertakes testing of each batch prior to release.
The National Institute for Biological Standards and Controls
This laboratory-based scientific organisation is dedicated to securing high standards of quality and associated safety and efficiency for the many biological substances used in medicine. NIBSC is also designated as a World Health Organisation (WHO) International Laboratory for Biological Standards.
This laboratory-based scientific organisation is dedicated to securing high standards of quality and associated safety and efficiency for the many biological substances used in medicine. NIBSC is also designated as a World Health Organisation (WHO) International Laboratory for Biological Standards.
