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GSK Verona Presentation Pack

GSK Verona Presentation Pack. May 2012. Sterile vial fill and packaging Manufacturer of cephalosporin products for GSK and 3 rd parties Global Supplier for Sterile Cephalosporins Flexible Partner, focused on Customer ’ s needs, ensuring quick responses and smart solutions

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GSK Verona Presentation Pack

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  1. GSK Verona Presentation Pack May 2012

  2. Sterile vial fill and packaging Manufacturer of cephalosporin products for GSK and 3rd parties Global Supplier for Sterile Cephalosporins Flexible Partner, focused on Customer’s needs, ensuring quick responses and smart solutions Reliable Organization, recognized for the highest quality standards adopted, with a continuous improvement mindset GSK Verona

  3. Brief Description of Site Capabilities • 4 aseptic filling lines equipped with the most advanced technologies and complying with the most stringent regulatory requirements; • Filling capability to cover a wide range of vial sizes: 10ml, 17ml, 26ml, 60ml, 77ml, 127ml plus Add- Vantage presentations; • 10 secondary packaging lines, for final customization; presentations with and without solvent, in single or multi-pack cartons; • Dedicated organization for artworks development; • Expertise in anti-counterfeiting measures design and application.

  4. Verona Regulatory Accreditations • Approval by all major Regulatory agencies: European Union, USA, Japan, Canada, Brazil, etc. • FDA approval for sterile dosage since 1983; • Last FDA inspection received in 2011 with no 483; • High Protected Risk (HPR) Site certification since 2001; • Regulatory approval for clinical trials manufacturing.

  5. GMS Verona – Performance Profile • Regulatory and compliance profile • External inspections with no critical observation since 2004 • GMS Verona never experience a recall related site operations • Customer service • Long records of delivery performance > 98% ( delivery time +/- 3 days ) • Patient profile • Justified Customer complaint rate inf. 1ppm • International Recognitions • In 2009 Verona has earned an Honourable Mention in the 2009 Facility of the Year Awards* for the revamping of aseptic powder filling facility 4 at the site, representing an evolution of aseptic • powder filling operations • Internal Performances • OEE aseptic filling ops: > 70% • OEE secondary packaging ops >50% • Active Yield: >97%

  6. GMS Verona - Products

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