Quality Management Systems for the BioPharma Cold Chain – Round Up

Andrea Charles

Globalisation and complex distribution channels raises concern over the quality of medicinal products as excursion may affect the safety, efficacy and potency of the product," Dr. Mary Mazur-Melnyk, Chief Scientific Officer, Innovalinks .

Understanding global regulatory expectations and defining the distribution supply chain and critical points is key for a successful biopharma cold chain.

Last week I attended my first virtual cold chain online training course led by Dr. Mazur-Melnyk, on Quality Management Systems for the BioPharma Cold Chain.

We all learn online every day, absorbing pages of relevant and sometimes irrelevant information from the Internet, but one of the advantages of the webinar platform is that it allows the participant, to do just that participate.

Quality Management Systems for the BioPharma Cold Chain was designed to help those involved in the process of manufacturing, storage, distribution and customer service to understand the complexity of the supply chain and importance of critical control points in ensuring quality product is delivered to the end user. The training course focused on the 3 Supportive Pillars of an Effective Cold Chain Management Process:

  • Quality Management System
  • Transportation /Storage Controls and Validation
  • Risk Management & Mitigation

In the first module Mary discussed what constitutes cold chain management and gave a brief overview of various definitions. She also covered the all important question "why companies need to manage their cold chain process?" As the session progressed we looked at general principles ofthe distribution supply chain and critical control points and finally the Quality Management System approach and how to identify compliance gaps.

There were some great takeaway slides but my favourites from the Quality Management Systems for the BioPharma Cold Chain course I wanted to share, were:

Key Critical Control Points in the Distribution Supply Chain

The Bottom line of all Guidances


  • Maintain the product safety throughout the supply chain.


  • Ensuring that a pharmaceutical package stays within a specified temperature range throughout its transportation and storage.


  • Documenting the steps that were followed in above process.

This course module set the scene for the cold chain management process and the current regulatory landscape and laid the foundations for following sessions which looked at defining the quality management system, qualification and validation, global shipping qualification master plans and CAPA and risk management.

If you missed out on the course, it is available on demand at www.coldchainqms.com

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