iSpeak Blog

ISPE GAMP® Blockchain Special Interest Group

James Canterbury
Tanya Sharma
ISPE GAMP® Blockchain Special Interest Group

The ISPE GAMP® Blockchain Special Interest Group is excited to be in its 4th year! For those of you following this space I’m sure you can appreciate the roller coaster of events across crypto, blockchain, and pharma over that time. Yet despite many of the external challenges the core technology behind blockchains has remained secure, available, and immutable – just as they were designed to do.

Within pharma/biopharma there has been an outpouring of use cases – from large manufacturers to startups to newly established NPOs – who are looking to decentralized technology to solve some of our industries thorniest supply chain issues and who are looking to access new markets and business models based on inventory transparency, trust, and efficiency.

According to a report by Grand View Research, the global blockchain technology market in healthcare is expected to grow at a compound annual growth rate (CAGR) of 66.1% from 2021 to 2028. Additionally, as per a survey conducted by Pistoia Alliance, 70 percent of survey participants thought blockchain has the potential to make a real difference in patient data management and sharing.

In our bi-monthly meetings, we host speakers who are involved in blockchain projects in (or around) pharmaceutical manufacturing. There are so many diverse viewpoints about the value the technology brings and how we can go about leveraging it – the discussions never fail to engage! Below are just a few of the topics that we’ve covered recently.

  • Supply chain management: Blockchain technology can create a secure and transparent supply chain by enabling the tracking and tracing of drugs. This becomes especially important in the case of personalized medicines where each patient’s therapy is individual and unique to them. The therapy needs to be traced back to that specific patient, so time and accuracy are critical. This end-to-end solution in the supply chain can also optimize inventory management and reduce the risk of drug shortages.
  • Clinical trial data management: Clinical trials can often have challenges with data management and sharing especially where clinics and sites are geographically dispersed. Having a blockchain based solution that has a permanent audit trail can ensure the security of patient data and enable real-time data sharing amount, multiple partners.
  • Counterfeit drugs: Blockchain technology can prevent counterfeit drugs from entering the supply chain and verifies the authenticity of drugs by creating an immutable and transparent record of transactions, which can improve patient safety and reduce the risk of counterfeit drugs.

Supporting the GAMP® principals (and often referring to the Blockchain appendix in GAMP® 5 Second Edition) we engage in discussion around:

  • Intended use and organizational policies: Based on the intended use, the qualification strategy and lifecycle requirements should be developed. Procedures should cover access control, data management, audit trail review, and how blockchain integrates into existing systems.
  • Data flow: This can provide a map of how data flows across the network (on-chain, off-chain) and interfaces with various systems, which can help identify key risk areas for data integrity.
  • Smart contracts: Smart contracts are computer programs that are self-executing if predetermined variables are met. They are a key feature of blockchain technology that provides a way to create and enforce trust in a decentralized and automated way. Critical features of blockchain (such as smart contracts) should be assessed and categorized based on the risk to patient safety, product quality, and data integrity.
  • Shared responsibility model: Having well-defined roles and responsibilities between the regulated company and blockchain provider is essential.

If this sounds interesting to you – we hope you will join us. For more information on this group please contact: and include “GAMP Blockchain” in your subject line.