Hovione is a contract development and manufacturing company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. As part of the digital transformation conference stream at Emerson Exchange EMEA 2024, Mariana Brás, senior process automation engineer at Hovione, explained how electronic batch reporting has helped ensure the company follows good manufacturing practices (GMP), reducing batch revision time, while also eliminating paper records and the associated potential for human error.
To ensure conformance to regulatory requirements, pharmaceutical manufacturers must document manual and automated procedures throughout the production process. Brás outlined that there are a number of challenges relating to this documentation process. These include human error when taking manual records, unnecessary duplication of manual and electronic records, and greater time taken by production and quality assurance (QA) departments to revise paper batch production records (BPR) that can extend the overall batch release cycle time.
Brás posed the questions: “what is the solution to those challenges?” and “how can you take advantage of raw data generated by batch recipes?”. The answer to both questions was electronic batch reporting.
Electronic batch reports produce valuable information about a process executed in batch mode in Emerson’s DeltaV distributed control system. Starting back in 2017, Hovione went through a multi-year process of implementing electronic batch reporting. Implementation consisted of installing and qualifying an electronic batch reporting system and three batch report templates:
These reports are used to support batch revision and release by the production and quality assurance teams.
The use of electronic batch reporting has allowed Hovione to review batches by exception, reduce batch revision time and reduce manual records on paper BPR by utilizing DeltaV electronic records (process data). Brás explained that a process exception report (PER) reduced the size of the report by up to 90% and the average time to review the report decreased by up to 67%. Hovione has also been able to eliminate duplicated records (electronic in DeltaV system and manual in BPR) and human error in manual records.
Manual and electronic records taken during spray drying.
A range of benefits have been realized in terms of productivity, compliance and sustainability. Greater productivity has been achieved due to a reduction in batch revision time. Production and QA time is saved, and workers can now focus on more important activities. The use of electronic signatures, elimination of duplicate records and alignment with ALCOA principles have all aided regulatory compliance. Digitally transforming from a manual paper-based system to electronic records has also created costs savings and a reduction in use of paper BPRs.
Some important learnings were also provided to delegates by Brás, such as how it was essential to define the report template with production and QA, and implementing the technology had to coincide with a change to work practices with quality procedures and manual BPR needing to be reviewed.
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