Regulatory compliance in the pharmaceutical industry is notoriously difficult and the strict nature of the industry doesn’t seem to be changing. Martyn Williams explains the steps pharmaceutical manufacturers can take on the road to compliance
The pharmaceutical industry today operates in one of the world’s most heavily regulated environments. Over the past few years, the industry has experienced significant regulatory change and looking to the future, the strict nature of the industry doesn’t appear to be slacking.
The repercussions of failing to comply with industry standards can be detrimental for pharmaceutical manufacturers. It’s no secret that the integrity and reputation of pharmaceutical brands is integral to their success. As a result, even the smallest failure can be irreversibly damaging.
With industry standards surrounding crucial elements like product integrity, energy efficiency, health and safety and product testing, there is more pressure than ever to ensure manufacturers begin to take steps towards compliance. In this elaborate regulations landscape, how do manufacturers ensure production operates in an efficient and effective way?
Digitisation of processes and the emergence of Industrial Internet of Things (IIoT) has transformed the entire manufacturing industry. However, for pharmaceutical manufacturers, the benefits of IIoT have far surpassed an increase in automated productivity.
The introduction of smart devices enables real-time data reporting to central control systems. Naturally reducing manual intervention and minimising adverse events during production. Paired with validation friendly software, an IIoT enabled factory provides live monitoring of regulatory reporting, potentially reducing the validation efforts many manufacturers face with a risk-based approach. This can greatly help to maximise production agility, allowing manufactures to respond to change and ultimately increase profitably.
For example, with batch control being a key step of the validation process, the combination of a smart factory and intelligent SCADA software couldn’t be more valuable. Automatically generating a trail of reliable audits, electronic signatures and real-time reporting, complicated pharmaceutical standards like FDA 21 CFR Part 11 are not so difficult to obtain.
The cloud and compliance
As manufacturers embrace IIoT, migrating to the cloud is the obvious solution to house and manage the growing expanse of production data. However, the cloud does more than just collect and store data, it allows manufacturers to gain actionable insights, directly from it.
Predictive analysis, for example, produces an intelligent forecast of when and where industrial equipment is most likely to fail. Using this data, contingency plans can be made to ensure, regardless of equipment failure, pharmaceutical production will continue to meet regulatory standards.
In addition, cloud computing enables simplified regulatory submissions. Using data stored in the cloud, manufacturers can directly feed digitised production information to regulatory bodies. This feature can be particularly helpful speeding up the lengthy process of clinical trials as well as post drug launch.
With the ever increasing risks concerning drug counterfeiting, efficiency challenges, adaptations to modern day agile processes and the industry-wide efforts to implement serialisation, it will be interesting to witness how IIoT can continue to solve these challenges moving forward.
Getting the green light
Over the past decade, the global focus on environmental sustainability has been hard to ignore. In industry, initiatives such as the European Union’s Energy Savings Opportunity Scheme (ESOS) and the voluntary certification ISO 50001, have put pressure on manufacturers to jump on the efficiency bandwagon. Using the same IIoT and smart software combination, organisations can gather comprehensive data from the entire factory and subsequently meet these efficiency requirements.
With copious regulations to adhere to, the pharmaceutical industry is under immense pressure.
Martyn Williams is managing director of industrial automation software expert COPA-DATA UK.