Data Analytics Good Practice Guide
The Pharmaceutical Manufacturing Technology Centre (PMTC), in collaboration with its industry partners has created ‘A Guide to Data Analytics for Pharmaceutical Manufacturing’
The guide aims to deliver good practice recommendations regarding the utilization of Data Analytics in the pharmaceutical manufacturing environment.
Compiled with over 400 hours of industry contribution, including the views of 14 multinationals and small to medium enterprises across surveys, focus groups and case studies, the guide has been written to support the increased implementation of data analytics across the pharma/biopharma manufacturing sector. The guide aims to encourage a range of discourse on the topic of data analytics by clarifying terminology, by highlighting and overcoming some of the business and technical challenges to implementing data analytics, and by bringing to light regulatory concerns and opportunities relating to the expanded use of data analytics across the sector.
The manufacture of safe medicines requires considerable regulatory oversight, adding complexity, which is not reflected in other sectors, and so, the guide was also reviewed in consultation with the Health Products Regulatory Authority of Ireland. There are 51 terms defined and referenced in the guide and the detailed case studies comprise almost 45% of the 80-page document.
The PMTC is seeking to continue to benchmark the use of data analytics, both within pharma and across other sectors and to support companies to navigate some of the complexities and regulatory considerations unique to the pharma/biopharma context.