Are you protected? PharmaShield. The Evolution of Generics

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1 Are you protected? PharmaShield The Evolution of Generics

2 Protection for those handling cytotoxics Recent research has illustrated that many vials of cytotoxics are not free from detectable levels of external contamination. Such contaminated vials represent a risk for staff involved in handling cytotoxic drugs, having specific health effects such as: Cancer¹ Birth defects¹ Leukemia² Spontaneous abortions² Congenital malformations² Skin rashes³ Infertility³ Are you protected? Our commitment Accord is committed to putting user safety at the heart of our offering. Accord is a dynamic young company unencumbered by past practice and with an appetite for refreshing the way in which safe and efficacious pharmaceuticals are delivered to users. Unlike many companies operating within the area of generic oncology Accord owns and controls all aspects of its pharmaceutical manufacturing, through 2 GMP approved* state-ofthe-art facilities. This gives Accord greater ability to control and optimize all aspects of products that could impact on user safety. Accord recognizes that we need to employ both Preventative and Protective measures in a systematic way to prevent occupational exposure. *MHRA, FDA.

3 PharmaShield central to our Preventative measures is PharmaShield PharmaShield is a system consisting on a superficial plastic sheathing around the vial, going from the reinforced non- PVC base to the vial seal. Key benefits of PharmaShield : Protects from breakage and spillage Protects users from external vial contamination Protects essential product label information The use of non-pvc materials protects the environment Latex free-protects users with sensitivity Reinforced non-pvc base: provides greater stability during manipulation and further reduced risk of breakage if vial dropped. Key benefits of vial seal: FLIP-OFF CAP vial seal PharmaShield DATAMATRIX CODE on label Line code No risk of sharp edges that could potentially damage user Minimizes potential disruption to crimp as FOC is removed Easy removal of FOC reinforced non-pvc base

4 PharmaShield Central to our preventative measures is PharmaShield Other product features Our entire range of product packaging has been designed to minimise the incidence of errors in dispensing, preparing and administering of our medicines Colour code assigned to the different strengths available All key information on front face of carton Barcodes and/or 2D Data matrix on carton and label: improved data accuracy to enhance stock control and reduce potential errors when dispensing the drug Clear identification of total dose/total volume Horizontal running lines represent the fill volume of the presentation. For each next fill volume there is one additional bolded line.

5 How we prevent external vial contamination Accord recognises that to provide the best standards in minimising external residue requires a systematic and consistent risk minimising approach. Our preventative process FiIling To ensure that all required cytotoxic material enters the vial cavity, Accord employ s an in-line volume/weight control as a core in process check on 100% of filling operations. Deviation from this check leads to vial rejection. Many competitor sites continue to use ad hoc sampling with a reduction in confidence. Lyophilisation Accord s research and operational specialists design into our advanced freeze dried processes a smooth sublimation step. This minimises the chance of bubbling and risk of migration of cytotoxic to the external surface for freeze dried products, as well as producing an elegant product cake. Incidental vial breakage In process vial breakage is a potential source of external residues on other vials. One key way in which Accord minimises this risk is by optimising the vertical load during vial crimping. A secondary benefit of this optimisation is ensuring optimum container-closure integrity. This helps reduce in transit leakage risk. Visual Inspection Accord s risk minimisation approach reduces the chance of external contamination. However, Accord doesn t stop here; instead we ensure that before leaving our factories 100% of our cytotoxic products undergo an extensive validated washing cycle and visual inspection: Washing Accord s validated washing protocols utilise industrial equipment that subjects each vial to a double rinse with purified water and then dried with compressed air. The validation of the washing process included extensive analysis of washing efficiency at a range of machine operating speeds, different vial sizes and for the most insoluble product in the range. Analysis of the vials after washing found that at operating speeds, all vials sizes sampled were below the test limit. Final visual inspection 100% of cytotoxic vials are subjected to final visual inspection across a preset range of parameters including; lack of external residue, crimp integrity, no vial defects. We have recently conducted an in-house study to monitor external contamination on 5-fluorouracil vials with the objective of determining the contamination of 5-fluorouracil present on the external surface of packed vials, based on a very sensitive analytical method. The results of the study have shown that all the vials from the different six batches subject to study had no measurable 5- fluorouracil contamination on the outside of the vials 4.

6 Our preventative process VIAL WASHING vials stored in quarantine (chemical test+biological assay) LABELLING PROCESS DEPYROGENATION PROCESS visual inspection Pharmashield technology Sterile core: Product filling and closing, as well as lyophilisation validated washing process Accord oncology products: Preventative+Protective FINISHED PRODUCT References: 1. DHHS (NIOSH) Publication No (2008). Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs docs/wp-solutions/ /pdfs/ pdf 2. NIOSH: Hazardous drug exposures in health care. 3. Huynh T., Jalundhmala Y., Subramaniam V. Hazardous Drugs. Maintaining Standards of Safe Pharmacy Practice. Pharmacy Practice News. 2010; Astron Research Limited UK, Monitoring of 5- Fluorouracil contamination on 5- Fluorouracil drug vials (2011). healthcare Ltd. Sage House, 319 Pinner Road, North Harrow, HA1 4HF, UK Phone: Fax: www. accord-healthcare.eu EMEA/ACC/015/02/12