Transcript GSK Verona Presentation Pack

GSK Verona Presentation Pack
May 2012
GSK Verona
 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
Brief Description of Site Capabilities

4 aseptic filling lines equipped with the most advanced technologies and
complying with the most stringent regulatory requirements;
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Filling capability to cover a wide range of vial sizes: 10ml, 17ml, 26ml,
60ml, 77ml, 127ml plus Add- Vantage presentations;
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10 secondary packaging lines, for final customization; presentations with
and without solvent, in single or multi-pack cartons;

Dedicated organization for artworks development;
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Expertise in anti-counterfeiting measures design and application.
Verona Regulatory Accreditations
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Approval by all major Regulatory agencies: European Union, USA, Japan,
Canada, Brazil, etc.
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FDA approval for sterile dosage since 1983;
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Last FDA inspection received in 2011 with no 483;
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High Protected Risk (HPR) Site certification since 2001;
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Regulatory approval for clinical trials manufacturing.
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%
GMS Verona - Products
ACTIVE Ingredient
Dose Form
Brand Name
Vials for injection (17,26ml)
Sodium Cefuroxime
Vials for infusion (77,127ml)
Zinacef
Curoxim
Monovial (18ml)/Advantage (22ml)
Vials for injection (17,26 ml)
Vials for infusion (60, 77,127 ml)
Ceftazidime
Monovial (18 ml)/ Advantage (22ml)
Fortaz/Fortum
Glazidim
Modacin
Intradermal Reaction Kit (10 ml)
Ceftriaxone
Cefoxitin
Cefazolin
Vials for injection (17, 26 ml)
Vials for infusion (60, 127 ml)
Ceftriaxone
Cefoxitin
Cefazolin