Implementing new technologies to reach Pharma 4.0 has become more prevalent among pharma companies. These new pieces of technology and innovations within the industry have necessitated a change in how companies validate their processes. Coined by the International Society for Pharmaceutical Engineering (ISPE), this shift in approach for validation is called Validation 4.0.

According to the ISPE, Validation 4.0 calls for developing a cohesive, harmonized, integrated, holistic, risk-based approach for process performance qualification. Validation 4.0 incorporates computer system validation that builds on the Pharma 4.0 operating model and includes a holistic control strategy, digital maturity, and data integrity by design.

An Image For The Pharma 4.0 Series Showing Validation 4.0

Pushing Toward Validation 4.0: What You Can Do Now

If your company is dedicated to reaching Pharma 4.0 and more specifically, Validation 4.0, adopting quality risk management (QRM) and quality by design (QbD) principles and practices into your validation processes is a great strategy.

Historically, we’ve seen a slow adoption rate of QRM and QbD practices within the industry. Getting your company up to speed on these practices will prepare you for innovations and ensure you’re not lagging behind.

It’s important to note that these changes should apply to all validation processes, not just your computer system validation. Companies that specialize in pharma qualification and validation like ICQ can assess your existing quality, change management, and validation policies and programs to steer you towards success. It’s vital to tailor your policies and programs to support the agility required for introducing Pharma 4.0 innovation trends and technologies.

Common Roadblocks to Innovation

While the journey to Pharma 4.0 and Validation 4.0 is undoubtedly exciting, it doesn’t come without its challenges. The path of changing the foundation of how your organization operates and adapting to new processes is bound to have roadblocks.

In our experience, we’ve seen that companies often need help developing a clear vision and encouragement to take risks. Other common pain points are the lack of technical resources, expertise, and/or the correct IT and automation infrastructure to embrace and adapt rapidly to the Validation 4.0 journey.

To avoid these pain points, companies must integrate building capabilities and a sound resources strategy into their technology strategy. In addition, internal regulatory teams must continue adjusting SOPs and guidelines towards a genuine and holistic QRM mindset rather than the traditional “check-box” approach.

Considerations to Make

Should you build upon current methodologies? Do you need to change your processes entirely to accommodate industry evolution? These are important questions to consider before making any massive overhauls.

It’s not all or nothing. Companies can implement a hybrid approach (i.e., build-on and new) by creating a multi-year technology roadmap (including capital expenditures) that integrates into their overall business strategy without losing sight of their YoY bottom line.

Whatever method your company uses to approach a shift in your validation strategy, ensure it’s a part of a holistic control strategy and that all stakeholders thoroughly assess the risks.

Your Journey to Validation 4.0

Need help navigating the journey to reach Pharma and Validation 4.0? Our commissioning, qualification, and validation experts can guide the way.