In 2015/16, the robustness of CSL's quality systems, plasma collection and manufacturing operations were challenged by 281 regulatory agency inspections around the world. As a testament to the organisation's commitment to quality and patient safety, these inspections resulted in no changes to our product marketing licences and provide significant evidence that the quality systems established globally by CSL are robust and in compliance with regulatory agency expectations.
The quality of CSL's end products begins with the quality of our suppliers. To supplement ongoing monitoring of supplier performance and to assure continued consistent high quality materials from our partners, CSL Behring and Seqirus conducted a combined 584 quality audits of suppliers worldwide. Efforts to enhance interactions with suppliers, at a relationship and quality perspective continue, with the establishment of centralised and holistic global supply chain quality functions.
Over the reporting year, under the lead of CSL's global pharmacovigilance function, the re-inspection of our pharmacovigilance system undertaken by the UK's Medicines and Healthcare Products Regulatory Agency successfully closed out findings from the previous inspection. In addition, we continue to enhance our technology platform with the rollout of a new global safety database and literature database. We further improved efficiency by process streamlining and controlled outsourcing, and introduced enhanced methodology for signal detection and risk management, enabling improved support of clinical development programs and post-approval safety surveillance.
During the reporting period, CSL initiated three voluntary safety-related product recalls. In Australia, Seqirus initiated two recalls of blood diagnostic reagents and one recall of its FLUVAX® influenza vaccine. For the applicable recalls, there were no reports or technical complaints to CSL from any source.
CSL's global counterfeit management policies continued to provide prompt responses to reports of counterfeit products. In 2015/16, CSL investigated 11 counterfeit product reports from four countries. Only one of these reports, which were investigated in conjunction with local law enforcement and health authorities, was found to be counterfeit.
|Company-wide audits and recalls||13-14||14-15||15-16|
|Quality audit of suppliers||435||497||584|
|Safety-related recalls of finished product||2a,b||3c,d,e||3f,g,h|