The pharmaceutical industry is unique as it must apply to stringent regulations and guidelines regarding quality and safety. Most of these regulations are also 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, making compliance 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.
Compliance from the outset
To meet the many regulations in the industry, pharmaceutical manufacturers tend to ensure compliance from the outset. Equipment is validated to perform accurately and reliably from the start, taking compliance into account even from the very early stages of design. 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 rather than as an afterthought can have both short- and long-term benefits for operations in any industry.
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 is not only a useful recording exercise, but it can also allow manufacturers to respond to any errors or non-compliance at the earliest opportunity and avoid more severe repercussions, which is beneficial in a number of other industries too.
Digitalisation in pharma
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 across 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 the ways in which manufacturers ensure total compliance whilst maintaining efficiency production and consistent product quality can translate across any sector. Taking a data-driven approach and keeping quality at the heart of the full journey of a product is a lesson that all industrial sectors can benefit from.
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