Reliable Partnerships and Regulatory Assurance: The Backbone of Biopharma Logistics
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsThis six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and evolving demands professionals like yourself face in ensuring product integrity from manufacturing to delivery. Amidst economic, technological, and regulatory pressures, the series begins with an overview of the cold chain validation process, emphasizing the need for comprehensive strategies to navigate competing priorities, sustainability initiatives, and the globalization of supply chains.
Click the links below to navigate to each article in the series:
Biopharma supply chain excellence starts by integrating your cold chain. By integrating your cold chain, you ensure that all the processes work together to achieve a common goal – to deliver quality medicines to the patients who need them.
A compliant cold chain management system is composed of various components working in concert. An integrated cold chain management system will ensure control of the distribution chain and consequently maintain the quality and integrity of products. These processes working together can produce consistency within the transport process, which allows the transport network to be validated.
The seven components are:
1. Quality System
2. Compliance Management
3. Risk Management
4. Partner Management
5. Qualification/Validation
6. Logistics Management
7. Product Stability
The appropriate tools, expertise, and experience are critical when coordinating your activities to ensure safety, safeguard quality, and maintain regulatory compliance. These measures must also be used to prevent falsified, adulterated, and counterfeit products from entering the legal supply chain.
Modality Solutions ensures compliance with these regulations by providing the following services:
You get results by focusing on implementation, not just defining regulatory requirements. A properly integrated cold chain ensures regulatory compliance, product quality, and patient safety. This provides a multi-layered approach that combines best practices of process validation, systems qualification, and risk assessment with the most applicable monitoring and controls for qualified packaging.
The next article of the series will discuss one of the biggest challenges and most effective tools to manage a world-class cold chain logistics network.
The pharmaceutical cold chain network is complex, but Modality Solutions makes it easy to simplify and streamline your cold chain. Working as a professional in the cold chain network means facing daily challenges. Just because the pharmaceutical cold chain network is complex doesn’t mean that your management system must be. Let our focused pharmaceutical cold chain engineering firm deliver results with our advanced technology and world-class engineers.
Here’s what you can expect:
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsIn the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsAre you aware of the open data files published online by the FDA? This...
read Details