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PROCESS AUTOMATION LEARNING LESSONS FROM PHARMACEUTICALS


Alexandra Hughes, Industry Sales Manager at COPA-DATA UK, explores the lessons that other sectors can take from the pharmaceutical industry


regulatory restrictions apply to the sector. Within this, pharmaceutical and medicine manufacturing is subject to 76,000 restrictions. These stringent regulations make quality assurance, good manufacturing practice (GMP) and monitoring essential — but what can other industries learn from how pharmaceutical ensures compliance whilst maintaining productivity? Most of the quality and safety regulations are


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put in place by regulatory bodies for either the point of sale or point of use, such as the Food and Drug Administration (FDA) or the European Union (EU). The consequences of not following guidelines can be anything from warnings and fines, to ceasing production and even, in serious cases, legal action. The way these regulations are enforced is strict, so compliance is essential. Though not all other industries are subject to


such strict scrutiny, sectors such as chemical production, food and beverage, or automotive to name a few, are all regulated and have their own compliance criteria. Looking to the future, it is likely that these regulations will become more like pharmaceutical guidelines, with a more data-driven approach to compliance. Now is the time for other sectors to examine


how pharmaceutical operations manage productivity and quality whilst meeting regulatory standards. To meet the regulations, pharmaceutical


manufacturers tend to ensure compliance from


anufacturing on the whole is the most regulated industry worldwide, with RegData estimating that over 217,000


the outset. Equipment is validated to perform accurately and reliably from the start,. The need to adhere to regulations is at the forefront of the process from start to finish. The pharmaceutical industry follows Quality


by Design (QbD), a strategic process for developing and manufacturing products, to ensure that a final drug or compound is what is expected, in terms of its quality, efficacy, and purity. At the heart of this is effective risk management and well-defined objectives from the outset. This can be a lesson to other industries —


setting out objectives from the design phase and developing a process to minimise risk and to ensure the resulting product meets industry standards. Achieving this can save time, reduce costs and ensure quality. Putting these factors at the forefront of the process can have both short and long term benefits. Ongoing quality assurance is also a


significant element of compliance in the industry, including the consistent monitoring of inline critical process parameters, offline composition tests, and continuous collection and recording of data. Having thorough records allows manufacturers to respond to any errors or non-compliance at the earliest opportunity and avoid more severe repercussions. Other sectors can also follow the


pharmaceutical industry’s lead in terms of digitalisation. Having a good system in place for continuous collection and contextualisation of data on process parameters indicative of


quality can give full process transparency. Taking this approach can allow manufacturers in any industry to go back to a specific batch or product and understand exactly what occurred in production at that point, and to pinpoint any errors or production issues. This also allows an operation to go paperless, automatically collecting data and reducing the risk of missed or lost information. An effective data acquisition platform to


allow continuous automatic collection and recording is key for sectors wanting to follow this example, and the benefits can apply to any type of manufacturing operation. COPA-DATA’s zenon platform can acquire


and record data, but also generate alarms and event lists and automatically detect whether a product or parameter is out of tolerance. This flags as an alarm, which can be referred back to at a later date. It also requires authorisation to make parameter changes and generates a list of any recognised changes or events outside normal production, giving full visibility of any deviations from the standard process. The pharmaceutical industry may be


more highly regulated than most, but taking a data-driven approach, and keeping quality at the heart of a product’s journey, is a lesson that all industrial sectors can benefit from.


COPA-DATA UK www.copadata.com


JULY/AUGUST 2022 | PROCESS & CONTROL 43


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