A Supplier’s View
Temperature Control: A Critical Part of Product Integrity
By David Bang, CEO, LifeConEx, LLC
Rx-360’s ultimate mission is ensuring patient safety by securing the pharmaceutical supply chain from various threats. In addition to criminally-motivated threats, such as counterfeited, adulterated and contaminated materials introduced by unethical or noncompliant suppliers, unintended threats, such as improper handling especially of temperature-sensitive pharmaceuticals, can compromise the efficacy and safety of drugs and pose just as serious of implications to patients’ safety.
The statistics of the British MHRA (Medicines and Healthcare products Regulatory Agency) ranks improper temperature controlled transportation among the top 10 GDP (good distribution practices) deficiencies with an incidence of 7%. The World Health Organization (WHO) published a study in 2006 evaluating the dangers of cool-chain mistakes for the efficacy of vaccines. Tetanus toxins, for instance, lose 15% of their potency after one freeze-thaw cycle, and more than 60% after two freeze-thaw cycles. Another WHO study shows that especially in less developed parts of the world, undesirable freezing during transport is more the rule than the exception. The study recorded freezing temperatures for 75% of Hepatitis B vaccine transports in Indonesia. In this matter, noncompliant logistics are prone to jeopardize efficacy, which in the long run will always fall back on the manufacturer of the respective pharmaceutical product.
Every fifth drug distributed is temperature-sensitive, and it’s expected that the share of temperature-sensitive products will continue to rise by 10-15% over the next years. Nearly 100% of all vaccines and 70% of all products sold by biotech companies need to be stored and transported between +2ºC and +8ºC. Controlled Room Temperature (CRT) is also becoming an important temperature range.
Additionally, trends toward increased global outsourcing and cooperation between pharmaceutical and biotech firms have brought about an increase in the transportation of temperature-sensitive goods. Demand for pharmaceuticals continues to develop as wellness and disease prevention grow in importance.
This increase in transportation brings shipping risks which could affect the product’s integrity and efficacy:
• Lack of integrated door-to-door management of all key partners
• Inconsistent standards and infrastructure across climate zones
• Uncertain transfer of accountability at each key milestone
• Lack of temperature monitoring and documented temperature excursions
• Inconsistent documentation of cargo handling through transportation
• Insufficient tracking & tracing for transport of temperature-sensitive cargo
To mitigate these risks, increasingly strict regulations governing the maintenance of particular temperatures and conditions during storage and transport have been developed. When transporting products internationally, there are a number of regulatory bodies involved with each shipment and stringent guidelines and standards to be complied with: FDA, cGMPs, EU Annex 13, ICH Guideline for Good Clinical Practice, WHO, country-specific guidance and ministries of health, USP 1079, and PDA TR 39. Quality standards are critical within the highly-regulated pharmaceutical and biotech industry.
To meet such regulations and maintain quality assurances, there are hundreds if not thousands of audits happening annually involving key players such as forwarders, truckers, airlines, airports, and warehouses. These audits are usually conducted by life sciences companies or by their designated lead cold chain solution providers. However, there are enormous opportunities in systematically sharing audit information, developing standards, and certification programs in the temperature control aspect of the pharmaceutical supply chain.
Temperature control is clearly a critical part of product integrity that will need to be addressed collectively and globally in the near future. The good news is that Rx-360’s current approach of developing and implementing audit standards, training and certification programs can also be applied to temperature controlled logistics.
The main goal of each pharmaceutical company is to regain and/or maintain patients’ health. Products adulterated through insufficient conditions during transport would thwart this goal, destroy a company’s image, and be pursued in court. We hope to see much more awareness of this topic among Rx-360 members and that it will trigger further discussions.