Top 5 Pharma Quality Trends and Predictions for 2018
The start of a new year is always a good to time to reflect on the past 12 months. By identifying some of the quality topics from last year, we can paint a better picture on how quality management will evolve in the coming year.
With that in mind, here are 5 key trends that we expect to carry forward into 2018:
- Data integrity
- Quality oversight and metrics
- Pharma 4.0
- Workforce transformation
- Industry cloud in life sciences
In 2016, after observing a series of violations involving data integrity, the FDA published “Data Integrity and Compliance with CGMP Guidance for Industry.” And based on similar observed failures in GLP, GCP, GMP and GDP inspections, the MHRA also published “GxP Data Integrity Definitions and Guidance for Industry” in the same year.
As a result, data integrity and addressing the regulatory requirements, were key themes at pharma quality management conferences in 2017, including the 13th Annual Quality in Pharma and Biotech Forum in Hannover. A number of presenters shared their experiences in meeting the new guidance. System security, user access, audit trails, and data were recurring discussion points, with key concerns including:
- A variety of quality systems are still in use, both paper-based and electronic, where shared logins are the norm and a full audit history may not exist.
- Applications like Microsoft Excel continue to be widely used for a number of operations, despite the lack of control over changes.
A strong indicator that achieving data integrity has been a major challenge for the entire pharmaceutical industry is also the fact that the ISPE GAMP reacted quickly and published a practical guide on “Records & Data Integrity” in March 2017.
This guide provides a great overview on procedural, behavioral, and technology aspects of data integrity and lifecycle management. A key take away is that technology may be part of the problem, but it’s also part of the solution.
Modern quality management systems built on platforms such as Veeva Vault are developed with compliance in mind, supporting adherence to 21 CFR Part 11 and Annex 11. By promoting the unification of content and data, they also help to ensure data integrity across the entire life cycle while providing users with a single source of truth for accurate GxP information and reporting.
Quality oversight and metrics
Quality metrics are considered to be an effective instrument for monitoring quality systems and driving improvements in GxP areas. However, the increased externalizing of critical operations makes it challenging to deliver accurate and comparable data.
The concern around keeping full quality oversight including CMO and 3PL activities was subject of a number of conference presentations. For example, at the Biomanufacturing Strategy Meeting, I hosted a roundtable discussion on how to ensure a strong quality and compliance focus with CMOs, partners, and suppliers. Some of the key issues highlighted were:
- There is typically no harmonized approach to CMO on-boarding, making it difficult to benchmark their performance by commonly agreed metrics.
- In many cases, externalization of GMP critical activities has resulted in unforeseen compliance risks that can only be identified at a late stage, with significant efforts for corrective actions.
- As regulators continue to focus on data integrity and common quality metrics, creation of standardized exchange of quality data will be a key imperative.
The conclusion is that sharing a single source of truth for product and batch related data by using one technological platform is the way to go. A modern and secure industry cloud, specifically intended for the use in GxP regulated areas is the key enabling technology for improving collaboration and quality metric generation in today’s pharmaceutical supply chain set-up.
For more detail on these points and more, watch our webinar on effective quality management across your global supply chain.
The concept of Pharma 4.0 continued to gain traction in 2017.
We are now seeing more pilot activities using digital technologies to help move pharmaceutical manufacturing to the next level. The ultimate benefit of Pharma 4.0 will be the transformation from automated (but inflexible) mass product supply into a highly adaptive set of manufacturing capabilities to produce individually tailored products.
Research analysts from LNS say that “quality improvement and monitoring are among the top use cases for Industry 4.0.” They propose a Quality 4.0 framework to help companies modernize and improve their existing quality management systems. Although this concept is not just about technology, LNS argues that “those that apply the technology to greatest effect will be the innovation leaders of tomorrow.”
ISPE hosted a number of conferences and workshops on the subject of Pharma 4.0 last year, including the From Industry 4.0 to Pharma 4.0 conference we attended in Verona. I predict that in 2018 we will see more traction and industry adoption on this topic, so watch this space.
Moving the pharmaceutical industry to a “4.0” maturity level will require new kinds of employee profiles and qualifications. The “Workforce of the Future” initiative introduced by ISPE, includes a variety of members from top pharmaceutical companies. It identified that in the next five to 10 years, the industry will need a highly skilled workforce with competencies that differ from the past.
The initiative is planning to work with the industry and academia to develop university curricula. During the initial phase with nine selected universities, they identified a number of potential gaps in university curricula:
- Combination products and delivering systems
- Robotics and automation
- IT data management, including data analysis, modelling, statistics, and data visualization
- Regulatory sciences, including cGMP and GMP hands-on training
- Project management, including risk management in manufacturing processes (biotech and small molecules) and related cost analysis
- Process analytical technology to achieve real-time release
ISPE promises to publish more information on their website in the near future, so expect to hear a lot more about this in the coming year.
Industry cloud for life sciences
We continue to see accelerated adoption of cloud in life sciences, with 120 Veeva Vault Quality customers including 30 Veeva Vault QMS customers. By adopting a cloud-based quality management system, companies can streamline processes by creating a single source of truth for all stakeholders. This enables quality professionals to access real-time information, creating operational efficiencies and achieving greater visibility for more informed decisions across the supply chain.
The industry cloud has the potential to modernize and unify quality management by enabling new ways of working for global teams. With the momentum we saw in 2017, I predict even greater adoption in 2018.
The hottest topics reflect the ongoing transformation of quality management in life sciences. Changing market needs and industry regulations are driving continuous change and innovation, resulting in new roles and responsibilities for quality professionals. In 2018, I expect to see more initiatives to address some of those trends. I look forward to writing a blog this time next year to see just how far we’ve come!
Want to stay up to date with the latest trends in quality management? Register to attend the Veeva R&D Summit, Europe on 12-14 June in Barcelona.