New Code for the Medicine Supply Chain

Cold Storage, Cold Chain Validation & Equipment Calibration

The National Coordinating Committee on Therapeutic Goods last month issued a new code on medicine wholesaling, superseding the 1991 Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use.

The code is relevant to those who store, supply or distribute medicines, and is designed to guide and promote a quality supply chain including:

• Storage and facilities maintenance
• Personnel skills and training
• Stock handling and control
• Timely and safe transportation
• Complaint management, returns and product recalls
• Standard operating procedures and document management
• Cold chain integrity
• Product and facilities security procedures
• Dealing with controlled drugs and those with high illicit value

One of the more vexing challenges of medicine wholesaling is maintaining the integrity of the cold chain, which usually involves specialised equipment and tightly controlled standard operating procedures. Section 8 of the Code offers guidance on managing the cold chain, from inwards goods through to dispatch and transportation. To ensure cold chain integrity, the Code recommends:

• Equipment and storage conditions should be calibrated, validated and regularly maintained.
• Storage facilities and packages should be monitored to record minimum and maximum temperature recordings, with alerts issued for any temperature deviations.
• Standard operating procedures should be in place, including what to do in the event of temperature exclusions and power failures.
• Labels should be applied to packages that alert members of the supply chain as to the nature of the goods and handling requirements, and these packages should be kept separate from regular freight.
• Temporary storage and packing areas must have an ambient temperature relevant to the goods. This is a common weak link in the cold chain.
• The delivery situation must be considered to factor weather conditions, possible exposure of product, time-distance and any abnormal environments.

To view the full Australian Code of Good Wholesaling Practice for Medicines, issued by the National Coordinating Committee on Therapeutic Goods, go to http://www.tga.gov.au/industry/manuf-medicines-cgwp-schedule2-3-4-8.htm.
If you need any additional information or would like to talk about how the new code will affect your cold chain logistics, please contact Andrew Gibson at CoolPac www.coolpac.com who is a temperature controlled packaging and cold chain validation expert.