Ideagen expert plays key role in new pharmaceutical industry software guidelines
Aug 02, 22
Ideagen’s Stephen Ferrell, contributing author on new guidelines that will affect global drugs manufacturing, says it’s the change the pharmaceutical and life-sciences industry has been crying out for.
Stephen, Vice President of IT Governance and Software Assurance at Ideagen company CompliancePath, is a member of International Society for Pharmaceutical Engineering (ISPE) GAMP 5 Steering Committee and authored parts of the revised GAMP5 guidelines which were released on 30 July 2022.
He said: “At the end of every pharmaceutical process is a patient, who expects that the software products used to drive the development of their treatment or medical device have been validated and are compliant with the regulations.
“This revision is in essence a codification of the ‘least burdensome approach’ and includes guidance on the use of elements such as blockchain, artificial intelligence and machine learning and brings it in line with the advancement of technology and the increasingly prevalent role it plays within the industry.
“The acceleration of these technologies in recent years has led to a position where they are now common practice within pharmaceutical engineering and life sciences. Equally, data security, globalisation and the integrity of software systems used to develop the medical treatments and devices that keep us safe and well, have never been more scrutinised.
“Revising the guidelines means we have global best practice which futureproofs automated manufacturing.”
GAMP5 (which stands for Good Automated Manufacturing Practice) is used globally to steer best practice for validating computer systems used within the pharmaceutical industry.
It ensures common standards to the processes that check a software product will consistently produce a result or product, meeting its predetermined specifications and this in turn provides pharmaceutical companies, and ultimately patients, with confidence in the standard and quality of the product. It adopts a risk-based approach in line with the application of both the European EMA, Chinese NMPA and US FDA regulations governing computer system validation.
The extended version expands guidance on the use of agile practices, software tools, AI and ML, blockchain and transformational digitalized pharmaceutical manufacturing (Pharma 4.0).
The latest guidelines can be found on the ISPE website.