eLN SUPPLEMENT
system and preparation of a Process Description by the R&D chemist is the starting point. Although this could be created from a blank eLN document, it is normally based on a ’clone’ of the definitive experimental write-up. The process description is improved by consultation with developmental manufacturing chemists and contains comments, observations and hold points. Electronic approval of the Process Description by an R&D manager is the final stage of the R&D part of the workflow.
methods. The procedure section is simply annotated as the batch is manufactured, and actual amounts, deviations, and minor process excursions are updated as necessary. Once the batch is completed, comments and learning points are added to the document, which is finally checked in for review and approved by line and quality assurance managers.
The effectiveness of the Stage Notebook as a central feature of our Batch Record system was reinforced during the pilot studies. Everyone
eLN-based documents Process Description Master Batch Record Batch Records (one for each batch manufactured)
Other documents (mainly Word and Excel) Cleaning documentation (eLN or Word from Vault template)
Stage planning documents (Word from Vault template)
Reaction and Chemical Hazard information Process Risk Assessment Documents Analytical Procedures (AMD) RM release documents (ATP) Process Flow Chart Additional post manufacture batch review documentation (if required)
Figure 5 Streamlined batch document workflow and responsibilities
Master Batch Record (MBR) The Development Manufacture department are responsible for the creation of Batch Records and for the early trials these were created, separately for each batch, by cloning, scaling and adding further manufacturing instructions to the Process Description. However, our pilot studies soon revealed that creation of a Master Batch Record (MBR) is advantageous. This is created by cloning the Process Description, scaling to an approximate batch size and adding further processing instructions. A strong feature of the e-workflow is that it enables easy knowledge sharing and collaboration between the R&D and manufacturing chemists during preparing the MBR, which is the key template for manufacture.
Individual Batch Records These documents are cloned from the Master Batch Record. Material amounts are scaled to the required batch size and populated automatically by the eLN, which ensures accuracy and provides considerable time savings compared with manual
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European Pharmaceutical Review Volume 16 | Issue 4 | 2011
associated with the manufacturing campaign acknowledged that the ability to have immediate access to up-to-date documentation was advantageous and improved knowledge sharing. Most importantly, QA managers found that they were able to take a more timely and interactive role in the manufacturing process. A typical range of documents contained in
the Stage Notebook are:
Most importantly for efficiency and effectiveness, each document has its own workflow, including checking and approval as required. The documents can therefore be assembled in the Stage Notebook in parallel prior to manufacture, where they are available for viewing / checking without holding-up the overall process.
Final system refinements Metrics collected during the trial showed that the system was considerably more efficient than the previous paper-based system, with a greater than 50 per cent time savings on docu - mentation. The risk-based re-evaluation of the document requirements and the use of the single Stage Notebook document repository
Figure 6Overall workflow for manufacture
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