A Cold Chain Process Validation Guide: Part 4: Component Qualification / Installment Qualification (CQ/IQ)
Robust test standards and test methods must be in place in your quality management...
read DetailsBiopharma 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:
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