What Makes Modality Solutions Your Cold Chain Regulatory Experts?

What Makes Modality Solutions Your Cold Chain Regulatory Experts?

Staying on Top of Regulatory Trends

Modality Solutions is constantly scanning the environment for updates to regulations and guidance – assessing the changes and how they impact the validation process. By leveraging their vast expertise, the teams at Modality Solutions know the application side of the regulations and can often anticipate regulatory reactions to your validation plan and submission dossier.

Refining regulatory expertise with frequent, practical experience

On an ongoing basis, the team at Modality Solutions continues to refine their regulatory knowledge as part of their everyday interactions with regulators all over the globe in over 40 countries.

Being an engineering consulting firm working in this space, the Modality Solutions team has experience with almost every available modality, temperature range, supply chain network, and more. This practical, daily experience as regulatory experts gives the team unique insight to access to the current thinking patterns of regulatory agencies on how to meet cold chain regulations.

>>> Related Webinar: How to Respond to Cold Chain IRs

Responding to IRs Requires the Right Data and Expertise

This expertise allows Modality Solutions to strategically assemble validation master plans, protocols, and data summaries in a report that meets (or often exceeds) the regulators’ expectations in multiple jurisdictions. We approach IR responses systematically with data and analysis using multi-disciplinary engineering skills:

• Provide the necessary information and data: A transport simulation study can confirm the worst-case shipping duration has no impact on product quality (e.g., biochemical stability). Analytical studies afterward on the drug product are strongly recommended to round out a sound validation package.
• Design the right study: The evaluation of the potential impact of commercial shipment (through each intended commercial shipping lane) on product quality can be performed as part of a simulated shipping study.
• Test at the edge of your operating space: Your drug product should be exposed to potential extremes during your transport OQ, including concurrent exposure to temperature extremes and ISTA Shock and vibration methodology. This approach will simulate the hazards of your commercial lanes at the extremes.
• No need to test after real-world shipments. PQ protocols do not require additional analytical testing if the OQ includes it in the acceptance criteria. Further analytical testing after completion of real-world shipping or performance qualification studies is unnecessary because the simulation study generated exposure to transport hazards in a controlled environment more severe than any exposures in point-to-point shipments.
• Justify your shipping lanes. Protocols for the finished product distribution must include the shipping lanes’ justification and acceptance criteria for evaluating the potential impact on Drug Product quality. We recommend using the actual commercial shipping lanes and temperature control in those lanes to assess the possible effects on DP quality.