Learn the key questions to ask every cold chain provider regarding their qualified solutions and support
A compliant cold chain is essential, but the challenge lies in choosing a trusted, qualified partner who knows how to build and maintain it. The primary drivers for building a complaint cold chain are patient safety, regulatory and accreditation requirements, cost of loss of medication, and risk mitigation. One of the most important tools you have for building a complaint cold chain is your cold chain provider.
In addition to providing qualified shipping solutions, your cold chain packaging provider should assist you with creating a proven and tested compliance manual for SOPs, a performance qualification plan, and pack-out documentation for all seasons. Qualified solutions from a pharma packaging expert who can provide test documentation, training, and ongoing support for their products is a fundamental part of your operation. You need an expert team who you can rely on for leadership, training, support, guidance, and process management across all aspects of your cold chain from pack-out to accreditation.
There are many essential tools in a compliant cold chain. A well-trained team is key as they are the ones responsible for managing the process and the personnel who are packing out medications for patients. In addition, ensuring that you have proper storage equipment and conditioning of refrigerants will help mitigate the risks of excursions.
Cold Chain Challenges
The pharmaceutical cold chain presents complexities and risks at every stage, challenges that are further amplified by the pressures of growth.
Ensuring patient safety and maintaining the efficacy of medication is of utmost concern. Delivering medication within the manufacturers’ guidelines for temperature is the most important goal.
To be accredited pharmacies must adhere to URAC and/or ACHC guidelines. Complying with these regulations adds complexity to cold chain operations.
To be accredited pharmacies must adhere to URAC and/or ACHC guidelines. Complying with these regulations adds complexity to cold chain operations.
The complexity of coordinating and designing test plans and interpreting data combined with a lack of in-house expertise on PQ qualification places pressure on your staff, processes, and operations.
You need a partner who provides training, support, and assistance with your PQ testing. Their team should support you through every step of building a compliant cold chain.
Maintaining precise temperature control across the entire cold chain, from manufacturing to final delivery, is essential for preserving the quality and efficacy of your cold chain medications. Carefully regulating the environment in storage facilities, during transportation under varying weather conditions, and at every handoff point requires advanced monitoring and precision pharma packaging products and protocols.
While technological advancements have greatly improved cold chain logistics, the human factor remains a critical vulnerability. Improper handling, lack of training, and simple human error undermines even the most tested and qualified cold chain solutions.
Building a compliant cold chain is achievable, but partnering with an experienced provider makes the process easier and more effective. The right partner understands your requirements and provides the expertise, solutions, and training needed to minimize risks tied to these critical factors:
How well does your partner help meet these requirements?
Qualifications for solutions
Training/support
Pack-out guidance
Solutions
The effectiveness of your cold chain depends largely on the expertise of your thermal packaging provider and the team behind their solutions. With patient safety relying on a compliant cold chain, choosing the right packaging partner is a crucial decision.