Modality Solutions cold chain experts recently published and made available its new Cold Chain Process Validation Guide.
The full-service engineering firm saw a need to address cold chain drug product process validation for the handling, storage, transportation, and global distribution for life sciences industries. The principles presented in the guide apply to the validation of a pharmaceutical, biologic or combination medical device in today’s regulatory environment.
With Modality Solutions, cold chain regulatory filing authorities, logistics network operators, and integrated expertise staffing firms combine as a single source of cold chain management engineering for the life sciences industry. Its new guide is intended to help cold chain logistics teams make sure their product supply chain handling processes are being performed appropriately for temperature, humidity, pressure, shock, vibration and other relevant environmental conditions.
The validation guide supports global cold chain regulatory requirements and addresses economic and regulatory pressures, accelerating costs, technology changes and the need to constantly adapt the business model. It provides solutions that deliver value while enhancing your regulatory reputation. It helps management see how to integrate its cold chain network to ensure all processes are working together to achieve the common goal of delivering quality medicines to the patients who need them.
The Cold Chain Process Validation Guide provides:
- An appropriate expertise and techniques to assess, control and communicate risk as part of an ongoing management review process
- A lifecycle approach to process validation including design, qualification, and verification
- Better integration of product formulation, controlled environment logistics, and packaging design
- Innovative, forward-looking quality controls, corrective and preventive action (CAPA) strategies and root cause analysis for once straightforward processes that are highly complex today
- Application of technology to achieve greater gains in all areas, including compliance, quality, and safety
Modality Solutions president Gary Hutchinson said: “Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets, these are just some of the challenges facing cold chain management professionals every day.
“The advent of more widely distributed supply chains demands greater investment in tools, expertise, and most importantly, human capital. For this reason, we pooled our expertise, knowledge and industry resources to create this important guide.”