Performance

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.

OUR SAFETY AND QUALITY PERFORMANCE

Company-wide audits and recalls 13-14 14-15 15-16
Regulatory audits 179 263 281
Quality audit of suppliers 435 497 584
Safety-related recalls of finished product 2a,b 3c,d,e 3f,g,h
a Two batches of INTRAGAM® P and two batches of EVOGAM® manufactured at the Broadmeadows facility (all from the same plasma pool) were recalled in September 2013 due to an unusual frequency and pattern of adverse events reported for one of these batches (root cause was not able to be determined).
b In November 2013, two batches of EVOGAM manufactured at the Broadmeadows facility were recalled due to the potential that a low number of defective stoppers (rubber enclosure) may have been used in the manufacture of these batches. Both batches were subsequently re-released (with regulatory approval) post satisfactory container closure integrity testing.
c In August 2014, bioCSL recalled one batch of red-back spider antivenom due to the presence of a single fibre identified in a vial during stability testing.
d In February 2015, bioCSL recalled one batch of Q-Vax Skin Test due to the presence of a fibre discovered in the product.
e In May 2015, one batch of ALBURX® manufactured at the CSL Behring facility in Kankakee and distributed in the US was voluntarily recalled following receipt of an elevated number of reported adverse reactions.
f In 2015, Seqirus in Australia recalled one batch of Abtectcell III 0.8% Cell 2 due to weak or negative test reactions for antigen E.
g In 2015, Seqirus in Australia recalled one batch of AHG Control Cells 3% due to weak or no reactions during antiglobulin testing.
h In 2016, Seqirus in Australia initiated a product recall for one batch of FLUVAX due to a low number of packs including no product information leaflets (PIL). In agreement with the regulatory agency, no actual product was retrieved from the market; however, a healthcare professional notification was issued with the relevant PIL information.