5 Things to Expect from Your Cold Chain Consultant

5 Things to Expect from Your Cold Chain Consultant

A cold chain consultant is a critical element of any pharmaceutical filing and approval process, but finding the right cold chain consultant can be tricky. As reputable cold chain engineers and consultants, we’ve narrowed down the five key things you should expect from your cold chain consultant partner.

1. Expertise in creating cold chain validation plans & thermal packaging qualifications
2. Extensive knowledge of global regulatory requirements
3. Frequent interaction with regulatory agencies / clear understanding of the most up-to-date best practices regulatory agencies expect
4. Practical implementation expertise & underlying technical skills
5. A history of success with regulatory interactions, submissions, and responses to agency inquiries

1. Expertise in Cold Chain Validation Planning

Today’s pharmaceutical cold chain is increasingly complex. Pharma manufacturers face competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets, and more. A proactive approach to cold chain validation planning is increasingly critical to mitigate timeline delays, information requests, and overall cold chain risk. The biopharma cold chain requires specific expertise in order to create the most cost-effective, risk-reduced cold chain validation plan.

Cold chain consultants should be uniquely qualified to maximize your odds of a smooth filing and ensure your cold chain is optimized for the commercial market. Their in-depth expertise should focus on the three vital areas of an effective supply chain: strategy, planning, and execution. Your cold chain consultant should help you develop an integrated cold chain management system that covers seven key components:

1. Quality Systems

• Quality manual, standards, and SOPs
• Good documentation practices
• NCs and exception management
• CAPA and change control
• Management review

2. Compliance Management

• Continuous improvement
• Effectiveness monitoring
• Critical-to-quality attributes
• Quality system maturity
• Import/export
• Emerging regulations/guidance

3. Risk Management

• Assessment and mitigation planning
• Plan design and documentation
• Monitoring and controls
• Review and communication
• Product protection
• Supply chain integrity

4. Partner Management

• Selection/RFP
• Quality agreements
• Audits and inspections
• Monitoring and controls
• Key performance indicators
• Subcontractor management
• Business review

5. Qualification Validation

• Validation master planning
• Design space/characterization
• Thermal profiles
• Transport lanes
• Thermal packaging
• Active refrigeration
• Logistics process
• Validation requalification/validation)

6. Logistics Management

• Qualification and training of personnel
• Premises and equipment
• Material handling, storage and inventory control
• Transportation networks
• Reverse logistics/product returns

7. Product Stability

• Storage temperature
• Shipping & handling temperature
• Stability testing to support logistics
• Stability budgeting
• Exposure/excursion management)

Your cold chain consultant helps ensure that the pharmaceutical supply chain is ready for the rigors of FDA review and the commercial market. Regular pharmaceutical consultants are great for consultation throughout the development of biologics or therapies, but it takes specific cold chain expertise to help obtain fast approval for drug products.

2. Extensive Knowledge of Global Regulatory Requirements

As the pharmaceutical and biologic industries become global, more API, Drug Substance (DS), and drug products are being manufactured in one region and transported/imported/exported to other regions around the globe. As a result, validation reports must meet global regulatory requirements for the appropriate locations, making global expertise increasingly important when looking for the right cold chain consultant.

Cold chain consultants who excel possess in-depth knowledge of the various regulations and requirements set by different agencies and jurisdictions worldwide. They effectively navigate these regulations by identifying similarities and devising efficient solutions to meet them.

The regulations and requirements for handling and transporting temperature-sensitive goods, such as pharmaceuticals, vary widely between countries and regions. These regulations are often set by multiple agencies and jurisdictions and can be complex and challenging to navigate. Cold chain consultants with global expertise are better equipped to understand these regulations and develop effective strategies for compliance, which is essential for companies that operate or plan to operate in multiple countries.

3. Frequent Interaction with Regulatory Agencies

Cold chain consultants stay up-to-date on the latest regulatory changes and evaluate their effect on the validation process. When selecting a consultant, it’s important to look for someone with expertise in applying regulations, who can anticipate and prepare for potential regulatory responses in the validation plan.

While pharmaceutical consultants or in-house specialists might interact with regulatory agencies once in a blue moon, cold chain consultants interface with regulatory professionals multiple times per month, keeping them up to date on the latest preferences and trends from the regulatory perspective. They know what questions to anticipate, mitigating potential questions and warnings before they occur.

Cold chain consultants gain diverse experience through regular interaction with regulatory agencies, including knowledge of various modes of transport, temperature ranges, and supply chain networks. This experience is valuable as it provides a unique understanding of regulatory agencies’ current perspectives and expectations regarding compliance with cold chain regulation.

4. Practical Implementation Expertise & Underlying Technical Skills

Utilizing a cold chain consultant who only consults is outdated and also risky. The most impactful cold chain consultants use analytical, scientific, engineering, and mathematical skills to solve complex cold chain challenges. (PS – that’s why Modality Solutions consultants are multi-disciplinary engineers.) Cold chain consultants should have a unique combination of technical writing and communication skills, which are essential to working with pharmaceutical companies, drafting regulatory responses, training supply chain professionals, and more. Hands-on experience, from thermal packaging to transport simulation to working with regulatory agencies, enables them to provide practical recommendations and see them through to implementation.

A cold chain consultant with underlying engineer expertise benefits the client by providing a more comprehensive service, as they not only give recommendations but also assist with testing and implementation. Their mathematical and scientific edge ensures that their recommendations are based on solid models and proven experience, ensuring that the cold chain is optimal, efficient, and compliant. Consulting Engineers also have the tools and skill sets to work with various pharmaceutical companies, whether it is a small emerging biopharmaceutical company or a large one with niche requirements.

Furthermore, cold chain consultants should have the resources and tools to test recommendations (like our Advanced Transport Simulation Lab™). A data-driven approach is necessary to validate the cold chain and ensure it meets regulatory standards and can handle the demands of the commercial supply chain.

>> Read Similar: What is a Cold Chain Consultant (+ why do you need a Cold Chain Engineer)?

5. A History of Successful Regulatory Interactions

As you search for a cold chain consultant, finding a partner with a track record of successful regulatory submissions, responses, and approvals is critical. The right cold chain consultant won’t just have experience across modalities, countries, and supply chain networks but will also have experience across the lifecycle of therapy approval. You should expect your consultant to have 15+ years of deep industry experience, not only consulting but with technical and engineering expertise – hopefully, a full team with access to their own simulation equipment and facilities.

About Modality Solutions

Since our founding, Modality Solutions has put a mark on the industry in a big way, with an exceptional record of success across a diverse group of therapies. For instance:

• 125+ biologics, advanced therapies, and drug-device combination products supported
• 80% of supported therapies are FDA Accelerated/Fast Track pathway drugs with rigorous cold chain demands
• 75+ drug approvals since 2018
• Global regulatory experience including US, EMEA, NMPA, and ANVISA
• 300+ successful thermal packaging qualifications
• 8 key cold chain regulatory guidance documents

Get in Touch with Modality Solutions