Selecting the Right Pharma Packaging Provider

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.

1. Ensuring Patient Safety and Preventing Loss of Efficacy of Medication

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.

2. Regulatory Compliance

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.

3. Providing Compliance Documentation for Regulatory and Accreditation Audits
   Maintaining a compliant cold chain operation is a critical priority for pharmacies and drug manufacturers, but it comes with a significant documentation challenge. Detailed records, reports, and forms documenting adherence to strict regulatory requirements are essential to remaining compliant.
   
   ISTA uses ISTA 7E to test and validate the performance of packaging systems used for temperature-sensitive products. Relying on real world data, the ISTA 7E certification proves your packaging can maintain required temperature ranges during shipping and distribution. Choose a provider who offers packaging solutions that comply with industry regulations and accreditations when packed out properly. Your provider should be able to answer your questions about regulatory compliance and standards.

4. Completing Performance Qualification Studies

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.

5. Temperature Excursions

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.

6. Human Experience

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.

7. Learning About Thermal Packaging
   
   There is a wide range of thermal packaging companies, technologies, packaging, monitoring, and support options. It can be extremely challenging to know who to trust and how to get started learning about the shipping solutions you need. Choose a provider who can offer you qualified shipping solutions. 

Cold Chain Requirements

 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:

1. Economical, dependable, and user-friendly cold chain solutions
2. Experienced pharmaceutical partner
3. Convenient product and solution ordering
4. Quick delivery on all orders
5. Reliable, available, trusted, and in stock pharma packaging
6. Accessible testing documentation
7. Training information, documentation, videos, and ongoing support

 How well does your partner help meet these requirements?

Key Questions to ask a Pharma Packaging Provider

 Qualifications for solutions

• Can you provide test documentation/validation for qualifying solutions? (Operational Qualification reports for shipping solutions)

Training/support

• Is ongoing support/training provided? (Should be a trusted partner not just a vendor.)
• Is engineering support provided for your modeling needs for your Specialty Pharmacy?
• Do you offer assistance with accreditation performance qualification testing?
• Will you train our staff/technicians with pack-outs?

Pack-out guidance

• Are seasonal pack-outs provided?
• Do you provide information on when to change pack-outs between seasons?
• How many different gel packs are used?
• Do you provide conditioning guidance for gel packs?

Solutions

• Do you offer a full suite of shipping solutions for Specialty Pharmacy needs?
• Do you offer a sustainable solution?
• Do you offer a longer duration shipper in addition to 36-hour 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.