eLN


SUPPLEMENT USING AN eLN TO CREATE


GMP COMPLIANT RECORDS FOR DRUG SUBSTANCE MANUFACTURE


John Leonard, David Fletcher, Matthew Harrison and Ian Menzies Pharmaceutical Development, AstraZeneca


We have developed a system whereby an eLN application (Symyx Notebook) is used for efficient technology transfer of processes from our R&D laboratories to our early clinical trials manufacturing facility, allowing electronic batch records to be created with improved efficiency and quality management relative to the paper system that was used previously.


In 2004, following extensive pilot studies, we introduced IntelliChem (now Symyx Notebook) as an eLN system for our process R&D chemists, replacing all our paper notebooks. The system was quickly accepted by the scientists, removing much of the tedium from experimental reporting and providing more reliable and more accessible records of our experiments. The electronic notebook had been installed and validated to be compliant with FDA 21CFR part 11 guidelines on electronic records (ER) and electronic signatures (ES), providing a secure audit trail of all activities that are recorded in the data system1


. The efficiency gains made by www.europeanpharmaceuticalreview.com


using the eLN for recording experimental work were quickly recognised and we looked for further ways to exploit the system to improve productivity. The supply of API (active pharmaceutical


ingredient) for Phase I clinical trials can be on the critical path of a drug development project, so is of the utmost importance to design and execute manufacturing processes as rapidly and effectively as possible. With the eLN in place for recording our process design experiments it became apparent that there was an opportunity to develop a more effective system for technology transfer of processes to our API


manufacturing facility and for documentation of the manufacture. The existing documentation system was recognised as being cumber- some and in particular, there were several transcriptions between different document types, each of these providing the potential for the introduction of errors (Figure 1, see page 16). It was envisaged that our eLN and its ER/ES


compliant document storage system (Symyx Vault) could be the basis for a more efficient process design and manufacturing record structure.


An iterative pilot-driven system design process An iterative pilot-driven design process was the key to developing a highly effective system that was not only accepted by the users, but also by a myriad of influential stakeholders. The


European Pharmaceutical Review 15 Volume 16 | Issue 4 | 2011


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