Last month, the FDA approved tafasitamab-cxix (official name Monjuvi®) in combination with Lenalidomide as a...
The need for a standardized package qualification process was recognized by the International Safe Transit Association (ISTA) in April 2014. Modality Solutions partnered with ISTA and spearheaded this standardization process.
Thermal Package Design & Qualification
Modality Solutions has the thermal package design and qualification engineering coupled with operational experience to help you maintain product quality and ensuring regulatory compliance.
The US Food and Drug Administration guidance stipulates that temperature-controlled biologics be stored and transported at labelled storage conditions 2°C to 8°C unless stability data is available to support storage at other temperature ranges. Manufacturers also target 2°C to 8°C as guidance for storing temperature-sensitive products.
Since nearly all speciality drugs on the market as of late are temperature and/or shock and vibration sensitive therefore require to be transported in packaging specifically designed to mitigate the risks of excursions or events affecting drug product efficacy.
Ensure Regulatory Compliance, Quality and Safety
Modality Solutions guarantees regulatory compliance for its clients. We not only perform the ASTM D4169 package qualification testing, we also test your drug product interaction with your primary packaging to avoid regulatory approval delays.
Our thermal packaging design and qualification minimizes or eliminates transportation environmental hazards in the supply chain. Modality Solutions enhances the reputation of our clients by ensuring regulatory compliance, drug product quality, and consumer safety during development through clinical trials and into commercial distribution.
Our principals have demonstrated subject-matter expertise in International Safe Transit Association (ISTA) standards, cGDP regulations, and Parenteral Drug Association (PDA) guidance documents, along with specialised skills in pharmaceutical packaging, import / export, and controlled-environment logistics management.
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