SETTING THE STANDARD IN GLOBAL TEMPERATURE

CONTROLLED HEALTHCARE SOLUTIONS

2014

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

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

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)

ARE YOU COMPLIANT

HOW DO YOU RATE IN A RISK ASSESSMENT

WHAT IS COST OF LOSING CONTRACTS AND CUSTOMERS

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

GCCS – TEMPERATURE PACKAGING AND MONITORING .

(15 -25 °C, 2-8 °C, -70 °C)

GCCS PREMIUM COLD CHAIN SHIPPERS

23 MODELS AVAILABLE

QUALIFIED TO CUSTOMERS PROFILES

THERMAL PACK COLD CHAIN SHIPPERS

7 PRE- QUALIFIED MODELS AVAILABLE

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 2 to 8 and 15 to 25 120 1250 1050 1250 260 1600 1400 1600

GCCS SINGLE EURO PALLET SHIPPERUsable Space - 1 x Euro Pallet EXT DIMENSIONS inc outer

GCCS HALF PAG 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 2 to 8 and 15 to 25 120 1900 1250 1200 360 2200 1600 1600

GCCS HALF PAG SHIPPERUsable Space - 2 x Euro Pallets EXT DIMENSIONS inc outer

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

TESTING CHAMBERS

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

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.

QUALIFICATION

Examples of Temperature controlled packaging designed and qualified

2ºC to 8ºC, 72+ hrs. Export Summer to winter

QUALIFICATION

Examples of Temperature controlled packaging designed and qualified to

Summer +55ºC conditions. Shipper 10ºC to 25ºC, 96+ hrs.

GCCS INDIA PRODUCTION

GDP Qualified Shipper

and Pallet Production

Cooling pad and phase

change element

Production

DATA LOGGERS

20

PHASE CHANGE GEL BRICKS

+24ºC, 0ºC ,-10ºC -16ºC -21ºC, -26ºC, -35ºC

OUR CUSTOMERS

“SETTING THE STANDARD IN

TEMPERATURE CONTROLLED

HEALTHCARE SOLUTIONS”