View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Modality Solutions
20 September 2018

Modality Solutions Release Cold Chain Process Validation Guide

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.”

Click here to download the brochure

Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets - these are some of the challenges facing cold chain management professionals every day. Solutions...
Regenerative medicine is a novel biomolecular approach to exciting new clinical therapies. Generally, this grouping involves three major therapy applications: cell therapies or stem cell...
Immunomedics ( is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company headquartered in New York City that specialises in discovering, developing and delivering innovative medicines for patients with...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Pharmaceutical Technology