A brief on how GCCS products and services can help eliminate the risk of non compliance in Shipping Temperature sensitive products.

1. SETTING THE STANDARD IN GLOBAL TEMPERATURE
CONTROLLED HEALTHCARE SOLUTIONS
2014

2. INDUSTRY REVIEW
• EU GDP guidelines now recognised global best practice.
• All supply chain must demonstrate compliance
• Harsh GDP inspections taking place Europe
• Pharmaceutical Inspection Co-operation scheme Pics
43 countries (USA, Canada ,South American, Europe ,Asia Australia)
• PICS adopted the EU GDP guidelines December 2014
• Many contracts are being lost from poor supply chain
qualifications
• Purchasers must prove temperature has been maintained
• Airline hubs all being GDP qualified
• Proper monitoring will highlight every failure – visible to
inspectors an auditors
• GDP applies to every partner in the supply chain

4. RISK
• Lost customers
• Legal claims
• 2014 U.K. Employed 16 new GDP inspectors to focus on supply
chain
• Non qualified suppliers are a risk
• GDP applies to Excipients and raw materials with temperature
storage conditions.
• Pharma companies licenses suspended for non compliance

5. MANAGING PHARMACEUTICAL PRODUCTS
GDP (Good Distribution Practice)
Principle:
• Pharmaceutical products are manufactured to high standards of
quality according to GMP.
• This quality must be maintained through the entire supply chain
• EU guidelines-Wholesalers and distributors must comply with the
requirements of GDP (Member States - Released September 2013)

6. ARE YOU COMPLIANT
HOW DO YOU RATE IN A RISK ASSESSMENT
WHAT IS COST OF LOSING CONTRACTS AND CUSTOMERS

7. We specialise in:
• Customised cold chain shipper design,
• Full GDP/GMP qualification reports
• Temperature recording solutions for warehouses
• Cold chain validation and transit profiling
• Environmental temperature chamber testing
• Temperature mapping and qualification reports of – warehouses,
refrigeration, freezers and cool rooms
• Data logger Sales service and calibration
GCCS – PRODUCTS AND SERVICES

8. GCCS – TEMPERATURE PACKAGING AND MONITORING .
(15 -25 °C, 2-8 °C, -70 °C)

9. GCCS PREMIUM COLD CHAIN SHIPPERS
23 MODELS AVAILABLE
QUALIFIED TO CUSTOMERS PROFILES

10. THERMAL PACK COLD CHAIN SHIPPERS
7 PRE- QUALIFIED MODELS AVAILABLE

11. GCCS AIRLINE PALLETS
EURO PALLET SHIPPERS
Net Weight Kg
Insulation Temp Range °C Transit HRS (L) mm (W) mm (H) mm (inc gel packs) (L) mm (W) mm (H) mm
80mm 2to 8and 15to 25 120 1250 1050 1250 260 1600 1400 1600
GCCS SINGLE EURO PALLET SHIPPER
Usable Space - 1x Euro Pallet EXT DIMENSIONS inc outer

12. GCCS HALF PAG SHIPPERS
NetWeightKg
Insulation TempRange °C TransitHRS (L)mm (W)mm (H)mm (incgelpacks) (L)mm (W)mm (H)mm
80mm 2to8and15to25 120 1900 1250 1200 360 2200 1600 1600
GCCSHALFPAGSHIPPER
Usable Space -2x EuroPallets EXTDIMENSIONSincouter

13. GCCS – GLOBAL HEADQUARTERS
• Administration and Manufacturing are located
on the same site to ensure continuity in the
operation of the business and fast turn
around time for orders.
• Our 3 temperature environmental testing
chambers on site for validation of shippers
from 1litre to 2000 litre capacity, for any time
period and any temperature range.
• Located in the freight hub of Melbourne for
ease of dispatch or receipt of goods.
Melbourne Airport is only 4km away

14. TESTING CHAMBERS

15. Qualification and Calibration
• Our testing chamber facilities are temperature
mapped and monitored.
• We have CFR 21 Part 11 compliant
temperature monitoring in all testing
chambers.
• All temperature monitoring equipment and
sensors used in validations are calibrated to
national and international traceable standards.
(NATA)
• Onsite Calibration lab.
• Packaging design and testing engineer

16. GCCS – FACILITY CONTINUED
Security
• 24 Hour Monitoring
• CCTV monitoring
• Electronic Key card access control
• All employees police checked
Quality Assurance
• GDP Quality Management System audited
by independent third party.
• All staff GDP trained.

17. QUALIFICATION
Examples of Temperature controlled packaging designed and qualified
2ºC to 8ºC, 72+ hrs. Export Summer to winter

18. QUALIFICATION
Examples of Temperature controlled packaging designed and qualified to
Summer +55ºC conditions. Shipper 10ºC to 25ºC, 96+ hrs.

19. GCCS INDIA PRODUCTION
GDP Qualified Shipper
and Pallet Production
Cooling pad and phase
change element
Production

20. DATA LOGGERS
20

21. PHASE CHANGE GEL BRICKS
+24ºC, 0ºC ,-10ºC -16ºC -21ºC, -26ºC, -35ºC

22. OUR CUSTOMERS

23. “SETTING THE STANDARD IN
TEMPERATURE CONTROLLED
HEALTHCARE SOLUTIONS”