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Quality Assurance

Our BPL Quality Management Framework supports the safety of plasma and plasma products in compliance with internationally accepted standards as defined by UK, US and European government agencies and regulators.

BPL embeds quality throughout all its processes, from welcoming plasma donors at its licensed collection centres in the US, through the manufacturing process, to tracking the safety and efficacy of its medicines in the patients who use them.

Our products are developed by pharmaceutical scientists, using the best available knowledge and technologies. Product quality is reviewed by national regulatory agencies before BPL marketing authorisations are granted.

Throughout the lifetime of the product, performance quality is reviewed against contemporary knowledge and understanding, allowing ongoing enhancements to be made to reflect developments in medical science and changes in the clinical environment. Performance is also monitored by national regulatory agencies, which undertake periodic inspections of BPL’s manufacturing facilities and quality systems, providing BPL with additional benchmarking for its process design and ongoing quality programmes.

We focus on quality is maintained throughout the product lifecycle, tracing any product from individual plasma donors to the patient, and from the patient back to the plasma donors.

BPL uses an industry-recognised pharmacovigilance system of post-marketing surveillance for any adverse reactions reported by healthcare professionals or patients who use its products, regardless of whether they are product-related. Any adverse events are investigated systematically, and are reported to the competent authorities as required by the findings. These pharmacovigilance systems are subject to inspection by regulatory authorities.

BPL is a member of the Plasma Protein Therapeutic Association (PPTA) and Ethical Medicines Industry Group (EMIG).