Source: Special Interest Briefing on Validation 4.0: Objectives, Working Model, and Relation to QBD

With that in mind, there is a need for a framework that assists in the transition to Validation 4.0 by showing how it maps to the PLC. A Validation 4.0 model highlighting this mapping was discussed in June of 2021 on an ISPE webinar on this topic. This model is the foundation for incorporating Validation 4.0 into the organization. It reviews the PLC stages along with the inter-dependency of some of the activities across the phases.

Product Life Cycle

PLC goes from Discovery, to Development, to Commercialization, and then to Post Market. The Validation life cycle has corresponding steps that provide data and feedback to ensure success. Quality by Design (QbD) attributes such as the Critical Quality Attributes (CQAs), the Critical Process Parameters (CPPs), the Critical Material Attributed (CMAs), and other key considerations would need to be incorporated into the PLC to provide the required visibility as well as monitoring of the overall process.

Quality By Design

Utilizing digital tools as an enabler across all stages of the validation process provides ready access to critical variables, parameters and requirements as they change throughout the process. It is important to note that QbD is not a signal step of the process but rather an iterative approach we use in order to learn more about our product and processes. With QbD, we accumulate information that assists in better understanding the products and processes so as to improve efficiency and optimization across all stages.

Planning & Control Implementation Stage

Stage 1, in the Validation 4.0 life cycle is the planning & control implementation phase. This maps to the discovery and development stage of PLC. In this stage, the organization’s user requirements are captured through process maps and data flows. This involves a digitization of the process leveraging technology. In this stage, the requirements that provide a better understanding of what the organization needs from a process and products perspective are contextualized. Additionally, a risk based assessment is applied that is associated with the process maps and data flows. This is where the risk is measured as it impacts product quality and patient safety. Criticality and vulnerability of the risk are both key considerations relative to this area.

Controls Stage

The Implementation of Controls is the next stage, Stage 2, in the Validation 4.0 Life Cycle. In this phase, we have digital tools in place to collect, report, and act on critical data in real-time.

Verify Controls Stage

The following stage, Stage 3, is the Verify Controls phase. In this stage, the critical data from the on-going process are continually monitored to provide opportunities for optimization as well as implement any changes to the system based on performance monitoring. The digital monitoring is to ensure that the design of the system to control the process and data is providing an acceptable level of risk. Data is leveraged for continuous improvement and optimization of the process. A continual feedback mechanism is required where the data is collected and analyzed in real-time so that the appropriate action on any discrepancies can be taken.

Summary

In order to successfully incorporate Validation 4.0 into the business, there needs to be an understanding of the Product Life Cycle (PLC). Additionally, the requirements associated with the processes and data need to be digitized so that they can be measured throughout the life cycle. This is required in order to ensure that the product quality and patient safety is kept at the highest level. To do this, there is a need for a Validation 4.0 model that maps to the PLC that can be leveraged to assist in ensuring the monitoring of the data and processes via controls. This model needs to incorporate the appropriate technologies that help to report, control, and improve the validation process across the life cycle. The validation process also needs to be continuously monitored to verify that standards are kept in place.

Why It Matters to You

Validation is the key to ensuring that product quality and patient safety are kept at a high standard. Validation 4.0 takes validation to the next level by ensuring that the processes are digitized and has the proper controls throughout the Product Life Cycle. In this blog we discuss:

• A Validation 4.0 model that assists in controlling product quality and patient safety.
• How the Validation Life Cycle maps to the Product Life Cycle.
• How data, processes, risk, and controls play a part in the Validation 4.0 model.
• Key elements of the Validation Life Cycle to consider to help ensure success.

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation &  staffing services for science-based businesses.  Through our proven laboratory informatics, digital quality & compliance, and scientific staffing services we deliver the highly specialized people, processes, and technology to fundamentally transform how science-based businesses operate.  Astrix was founded by scientists to solve the unique challenges which science-based businesses face in the laboratory and beyond.  We’re dedicated to helping our clients speed & improve scientific outcomes to help people everywhere.

The post Validation 4.0 Model for a Digital Transformation of the Life Sciences Industry appeared first on Astrix.

Challenges Impacting the Implementation of Pharma 4.0 and Validation 4.0

People, Culture, and Skillset Challenges

Manufacturers and regulators will need to make cultural adjustments and innovate to manage the myriad of data, computing, and automation hazards on the way to full adoption of Pharma 4.0 and Validation 4.0 guidelines and the technologies required to get there. In order to achieve optimization, knowledge and training gaps will have to be addressed in the adoption of a new paradigm and industry infrastructure based on digitized and interconnected enterprise systems that rely on computational power, communications technologies, cybersecurity, and advanced controls.

For example, to implement AI and other advanced technologies in pharmaceutical manufacturing, a variety of expertise beyond traditional biology, chemistry, and process engineering will be required. Data scientists, computational and systems engineers, IT specialists, and AI experts, for example, will most likely be needed. At least initially, regulators and business may be fighting for the same tiny pool of talent in these areas. New labor force training standards are undoubtedly on the way, and comprehensive training programs will be required.

There will also be a need to understand the operation of smart devices that will enable monitoring and operating from a distance by operators and supervisors. These technologies will simplify the changeover, setup, and maintenance and the life cycle management. There will also be a need for the workforce to operate cross functionally, integrating several disciplines.

Incorporating best practices and new technologies into the business is required. The difficult part is changing the culture and persuading individuals to accept a new way of doing business after having done things a certain way for many years. Organizational Change Management will be necessary (OCM). OCM is the “application of a systematic process and set of tools for driving the people side of change to accomplish a desired outcome,” according to Prosci, the global leader in change management best practices research. Additionally, strong communications, with a leadership team eager to drive positive experiences through technology, will be required.

Planning and Process Challenges

Because the potential for Pharma 4.0 is so great and so wide-ranging, many pharmaceutical companies are racing to implement the technology and haven’t defined their primary goals and what problems they’re seeking to solve.

If these two important questions are not answered before starting down the path to Pharma 4.0, the direction will be unclear, and many firms will lose sight of their objectives and goals. The organization’s business processes will undergo significant changes as a result of the major technologies required for digital transformation, and those changes must be acknowledged and understood before they are implemented. The company needs to have a strategy and a plan to get there.

Pharma 4.0 and Validation 4.0 require an holistic control strategy. A strategy that follows the product from research to development, to tech transfer, and then through to commercial manufacturing. With this strategy there also needs to be a synergy between digital automation and guidelines and an enhancement of the quality manufacturing focus, where Quality Target Product Profiles are required for all products. With this control strategy, the data from machines and components is immediately available without traversing various systems . The operators’ remarks can be automatically recorded making the continuous improvement process easy to implement.

Technology Challenges

Transitioning to Pharma 4.0 and leveraging Validation 4.0 guidelines requires incorporating new technologies and ensuring that everything works together to produce reliable data across the value chain. The technology needs to provide a means to integrate data and eliminate the silos that may exist throughout the organization today. These data silos can exist across process areas, applications being used, and organizational groups. A few examples are business quality data, IT quality data, product quality data, and supplier quality data. In many situations, the data is not being collected using the same method and this incongruent data has a negative impact on the decision process. Many times, this leads to inefficiencies and sometimes costly inaccuracies.

Organizations need to look at technology solutions across the value chain. From the company’s business partners and the customer perspective, the organization needs to be able to make informed decisions based on data compiled from various sources and to communicate specific aspects of that data accurately to suppliers, vendors, and customers.

Innovative technologies also necessitate new processes and more regulatory scrutiny. Manufacturers must remain nimble and able to adopt new skills in order to improve manufacturing and provide high-quality products.

To connect the essential instruments and equipment, the technology including tools, devices, and IT systems must be on an open platform with common data standards and, most likely, be cloud-based to enable data sharing. Integration and traceability, as well as automation, rely on information systems that eliminate needless manual or human interaction while also lowering regulatory scrutiny. Leveraging the right technology across the organization that is integrated and provides consistent and accurate information is imperative.

Operating within existing regulatory frameworks can be considered another challenge for Pharma 4.0 and technical innovation when it comes to regulatory restrictions. Due to a lack of regulatory precedent, the industry may continue to use old practices even though new processes will lower overall regulatory burden and improve quality in the long run.

Summary

Moving to Pharma 4.0 and incorporating Validation 4.0 guidelines impacts the entire organization. There are challenges that influence the success of an organization meeting its objectives with Pharma 4.0. These challenges are in the areas of people, processes, and technology. To move to this new approach, it will require training of the people and a cultural shift to be successful. It will also involve an understanding of the objectives of the move to Pharma 4.0 and the processes involved and an holistic control strategy. Additionally, with Pharma 4.0, there is also the technology aspect. This requires an understanding of the new technologies so that everything works together to produce reliable data across the value chain.

Why it Matters to You

Before an organization embarks on an initiative to implement Pharma 4.0 and Validation 4.0 guidelines into the business, there needs to be an understanding of the areas that could provide challenges. These challenges impact the success of the organization. In this blog, we discuss:

• The key challenges faced by organizations looking to implement this new approach.
• The impact of training and cultural on the move.
• What a Holistic Control Strategy role is in the implementation.
• Technology consideration when implementing this new approach.

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation &  staffing services for science-based businesses.  Through our proven laboratory informatics, digital quality & compliance, and scientific staffing services we deliver the highly specialized people, processes, and technology to fundamentally transform how science-based businesses operate.  Astrix was founded by scientists to solve the unique challenges which science-based businesses face in the laboratory and beyond.  We’re dedicated to helping our clients speed & improve scientific outcomes to help people everywhere.

The post Pharma 4.0 and Validation 4.0 – The Challenges of Implementing appeared first on Astrix.