What is Validation for Pharma 4.0?
A fundamental cGMP requirement is that systems, processes & methods which are used to manufacture medicines are validated, meaning their fitness for purpose is demonstrated. For success in Industry 4.0 in the pharma space, the manufacturers need to transition from the old ways of approaching compliance & embrace this new age of data-powered technology.
Let us discuss how can we shift our mindset for achieving Validation 4.0
Transitioning from the Traditional Ways
For Validation 4.0, we need to move on from creating historical documents of what was tested to focus instead on real-time verification of product quality by managing specification and evidence data around a process that is in a state of control throughout the life cycle. Standalone documents are clearly not suited to continuous verification, and the masses of documentation created by both suppliers and regulated companies in the name of validation are inefficient, difficult to maintain, and perhaps not auditable.
Digital artifacts managed with appropriate tools can instantaneously provide reporting and notifications on the state of control. The systems used widely today by agile software developers for cloud solution providers are a good reference point for Validation 4.0 to leverage and integrate quality management efforts into our ongoing activities of continuous verification beyond what is possible with static documented evidence.
Data – The Foundation
Data integrity has been a buzz term for years now. A whole subindustry has been built around this concept, and yet we still fail to truly embrace what it means and how to implement it. Data is the foundational element of validation and the basis for decision making. When we consider validation, we need to shift our focus to how we control the data that allows us to make GmP decisions and look at validation under a QbD lens.
The focus of validation changes from qualification testing to ongoing and constant assurance that the needed controls are in place and operating correctly. This continuous verification of the process and risk is the primary evidence that the process is in a state of control. By using real-world data to feedback into our process, data, and risk evaluation, we can be assured that our products are constantly manufactured and released based on sound data, and through this model, we can continuously reassess risk conditions and handle inherent process variability.
Majority of the pharma giants have already begun the use of data architecture which includes data warehousing, data marts, data mining for checking the effectiveness of each dosage on their patients, collecting and analyzing medical report (pathological) of person undergoing test to facilitate R &D, manufacturing, supply chain.
Transitioning from Validation to Validation 4.0
As per US FDA, “effective process validation contributes significantly to assuring drug quality”. Process validation is a series of activities that occur over the life cycle of the product.
Validation Life Cycle
While process validation covers and takes care of the following things:
- Create quality target product profile
- Identify CQAs
- Define Critical Process Parameters
- Evaluate the process to verify that it can reproduce consistent & reliable levels of quality
- Detect & resolve process drifts
Validation 4.0 covers these aspects:
- Holistic planning & design.
- Conduct process and data flow risk assessment at the design stage, incorporating criticality and vulnerability to define the control strategy, and to implement data integrity as a fundamental aspect of QbD.
- Automate to rapidly ensure that planned controls are in place / effective.
- Incorporate data from across the value chain (from raw material suppliers to patients) and product life cycle to evolve the control strategy into a holistic control strategy.
Conclusion
By moving to a process and data-centric approach to validation, and finally establishing a baseline for incorporating QbD, the pharma industry can move to continuous assurance of product quality throughout the product’s life cycle, and at every point in time.
