Abstract
In the pharmaceutical industry, process validation tasks are based on the generated process raw and derived analytical results. Risks to fail in process validation, affect both, the patient’s safety as well as the economic success of the manufacturing company. Hence, data integrity is highly critical in this area. Regulatory agencies, such as the FDA, reacted to past data integrity breaches, by publishing new guidelines on data integrity for the correct handling of data in the pharmaceutical context. In this contribution, we want to show how data integrity can be improved on a technological level, removing the need for trusted third parties and centralized systems for this task. Therefore, we implemented an approach that uses existing tools, today mostly used by software developers, and combined them with a new smart contract built on top of the Ethereum blockchain. In a case study, we test how data manipulation or back-dating of results can be easily detected and how regulatory agencies can audit the complete data flow, from the regulatory report back to the original raw data. The results of this contribution outline a possible roadmap for the development of production-ready tools, like versioned database systems that natively interoperate with distributed ledgers. This will improve the trustworthiness of pharmaceutical manufacturing data by doing both, protecting the intellectual property of the industrial company and improving the safety of the patients.
- Received August 7, 2018.
- Accepted January 30, 2019.
- Copyright © 2019, Parenteral Drug Association
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
Log in using your username and password
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.