What the New ISO 21973 Guidance Means for Cell and Gene Therapy Developers

Mon, Nov 16, 2020 | By Rob Jones, Vice President of Global BioServices

You may have heard about the release of ISO 21973:2020, but are wondering what it means. Our experts are here to break it down for you. 

Firstly, what is ISO? 

The International Organization for Standardization is made up of nearly 800 technical committees. It has published over 23,000 standards covering all aspects of technology and manufacturing. 

What is so significant about ISO 21973:2020?  

Pharmaceutical companies are required to comply with stringent national and international standards, regulations, and laws when developing and manufacturing their products. However, transportation companies – who are a critical part of distributing  cell and gene therapies—are not required to comply with those same rules, putting the product at, potentiallysignificant risk. That's why ISO 21973:2020, titled “General Requirements for Transportation of Cells for Therapeutic Use,” is important: it is a significant step forward in ensuring that these life-saving and life-changing therapies are always transported consistently, with an emphasis on compliance, validation, decontamination, traceability, and quality management.  

Who developed ISO 21973:2020? 

ISO 21973 has taken several years from initial concept to final publication, and has involved major organizations such as the FDA, NIST, the Alliance for Regenerative Medicine as well as key opinion leaders from industry and academia. Cryoport is proud to have been involved as an industry leader in the development of ISO 21973 and, as you read through the standard, you will see many references to our standard processes: 

ISO Requirement 

  • Documentation Compliance 
  • Decontamination 
  • Traceability 
  • Segregation of Human vs Animal derived products 
  • Validation & Qualification 
  • Quality Management 

 How Cryoport Meets the Requirement 

  

Our involvement in defining the standard has ensured that we meet the requirements of ISO 21973, which is something that many transportation organizations cannot claim. 

So is Cryoport ISO 21973:2020 compliant?  

Not yet. When there is an accredited body capable of performing the audit for ISO 21973:2020, we are confident we will achieve inspectional success.  

Has Cryoport achieved any other ISO accreditations 

Yes. We recently achieved ISO 9001:2015 accreditation, which evaluates the strength of an organization’s quality management system and associated processes. It assesses if all processes and systems are sufficiently robust, sustainable, and adhered to by employees at all levels of the organization. With the ISO 9001:2015 certification, Cryoport can provide a third party’s validation of our exceptional level of quality and organizational discipline. 

Get Early Access to Cryoport’s ISO 21973:2020 White Paper

Cryoport’s experts will release a white paper about the details and ramifications of ISO 21973:2020. If you’d like to be the first to get a copy delivered to your inbox, please sign up here.

Questions or comments? We welcome your feedback!

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