eLN SUPPLEMENT


Notebook technical expert. We also had a strong line of communication with technical staff at Symyx, who could advise on current system capabilities as well as the potential for future developments. The relationship we built with Symyx was mutually beneficial, as learning passed in both directions. Based on feedback


including documentation, checking, witnessing and approvals. In-line with ICH-Q9, we took a risk-assessment-based approach to all our quality management procedures and we instigated a ‘Planned Change’ procedure to enable the use of the electronic system in the GMP environment. We continued with an


Figure 3 Simple early model for e-Tech Transfer


from the initial pilot we were convinced that we could demonstrate to the stakeholders far- reaching benefits that they had not conceived of, by moving from paper to electronic record systems. However, GMP compliance within an electronic system requires a change of mindset because the established approaches to judging the validity of paper-based systems cannot and should not always be applied directly in the electronic world. We made bold promises to the stakeholders


when we started to devise ways that we could work in a GMP environment:  To improve effectiveness and efficiency  Faster and more accurate tech transfer and process scale-up


 Better communication between the R&D chemist and manufacturing chemist


 To create a better Quality Management System!


 Providing transparency of process information


 Immediate accessibility of key information for QA managers


To make these objectives credible we began the next phase of the project by taking a holistic view of our development manufacturing procedures. We found distinctly different ways of working in each of our manufacturing facilities, including different approaches to GMP compliance. For the e-Batch record pilot studies all aspects of the system were re-evaluated,


www.europeanpharmaceuticalreview.com Figure 4 Simple flat folder structure showing key Stage Notebooks


The Stage Notebook: a repository for manufacturing records One approach that we tried was to create a single eLN document and attach all the other relevant manufacturing documentation, such as safety assessments, analytical procedure etc., The idea was that once the document was assembled there would be a single ’container’ for all aspects of manufacturing documentation


trials over a one-year period, covering the manufacture of a significant number clinical trials API batches, mainly for Phase I studies. Through an iterative learning process we refined the manufacturing documents and workflow, including the approvals and checking regimes.


 The Process Description eLN-based documents are at the core of the


European Pharmaceutical Review 17 Volume 16 | Issue 4 | 2011


iterative approach: testing concepts, collecting feedback and making refinements. It was this approach that enabled us to break away from a mindset that had been moulded by requirements of paper-based documentation systems and instead redefine a more effective business process.


and that this could be approved as a whole. However, it soon became apparent that this way of thinking was a legacy of paper-based approaches and was inappropriate in the electronic world. The problem was that the ’Method of Manufacture’ document created a bottleneck in the workflow. Understanding this triggered an important breakthrough in our thinking! What we required was a workspace where all manufacturing documents could be stored and approved in parallel and instead of creating a single document we decided that the most effective approach would be to create a single Symyx Notebook (a virtual e-folder) for every stage of the manufacturing process, held within a campaign folder. This was a major step forward – for the first time we had created a single repository for all documentation associated with manufacturing in a version controlled ER/ES compliant data system (Symyx Vault). This was something that QA colleagues really appreciated as all the relevant documents were easy to find, either by searching the system or simply browsing in the simple flat folder structure.


Learning through pilot studies With the principles of our holistic e-batch record system in place we conducted extensive GMP


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