The promises of what a digital transformation can bring are new and exciting, but also challenging and complex. For pharmaceutical and biotech companies, the use of digital technologies to accelerate drug manufacturing may be challenging and more complex due to the possible impact it could have on product quality, and ultimately patients. The industry is still looking for the best practices for its digitalization strategy and looking for a secure plan due to strict regulations and the inescapable need for ongoing GxP compliance.
Looking to the future of pharmaceutical and biotech industries, novel digital transformation technologies such as artificial intelligence, deep learning, and machine learning will absolutely play a part in their growth, success, and ability to stay competitive in the growing, competitive market. It’s no secret that the industry is facing pressure to innovate due to an increase of personalized medicine, stricter regulations from the FDA, and competition creating a need for faster time to market. So as the Pharma 4.0 shift begins to take place, GxP compliance, data integrity, and regulations are something that needs to be considered when creating a digital strategy.
Why is GxP compliance important?
Changing Regulations
Regulations, and interpretations of regulations, are not static because there are constant updates that are being made to regulations by the FDA in order to protect their first priority: patient safety. To overcome these hurdles, having scientific evidence or trustworthy data readily available of your manufacturing processes will allow you to prove your processes are compliant and medicine was produced as it was intended to.
A GxP-compliant platform can provide the evidence regulators are requesting, also when deviations occur and the need to document how true root causes were identified arises.
Early Decisions Matter
Starting with a GxP compliant platform from the outset of your digital journey will allow you to avoid the all too frequent scenario of the last 20 percent ballooning into 80 percent of the cost when GxP decisions will be made from the use of digital tools and applications (and hence require validation). Planning and designing for the end-state of fully validated solutions from the beginning will allow you to budget correctly and be ready to take advantage of the learnings that will surface with better use of digital tools. Making the choice will also help you understand your processes better and have unrestricted possibilities with a GxP platform. Imagine having to go backward in a project or not be able to take advantage of an opportunity to improve a critical manufacturing process, just because you didn’t anticipate the need of your digital platform to be GxP-compliant.
Regulators Are On Board
The industry cannot excuse any lack of digital adoption or progress with arguments based on the uncertainty around how their use of new tools will be judged by regulators. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK established a GxP Data Integrity Guidance for cloud providers including Software-as-a-Service, Platform-as-a-Service, and Infrastructure-as-a-Service. And the FDA (Food and Drugs Administration) has incorporated cloud technology into their Emerging Technology Team recognizing that it will influence how quality systems will be assessed by the FDA.
An effective and successful digital transformation can bring a magnitude of benefits, improving speed and efficiency while maintaining compliance. Ultimately, the most important goal is to provide better treatments for patients and as regulations become more strict, companies must consider GxP compliance and ensure data integrity when creating and executing their digital strategy and culture. At Bigfinite, we consider ourselves to be enablers of Pharma 4.0 and inspirers of AI in regulated environments. The Bigfinite platform was born from new digital technologies with a unique focus on life sciences and specifically pharmaceutical and biotech manufacturing.
To learn more about the importance of GxP compliance and Pharma 4.0, register for Bigfinite’s upcoming webinar.
This article was created in collaboration with the sponsoring company and the Xtalks editorial team.
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