The “business as usual” approach to process validation has come to an end for the pharmaceutical industry with the increased pressure to adhere to revisions outlined in the FDA’s Guidance to Industry for Process Validation. As a result, companies are beginning to understand that process validation is no longer a “one and done” activity.
The pharmaceutical industry is currently undergoing a serious transformation as it slowly embraces the revised FDA Guidance to Industry for Process Validation. Introduced in January 2011, the Process Validation: General Principles and Practices is aimed at, “Increasing process understanding and control with the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality products.” As many companies are learning, the new guidance requires continuous over time as they continue to collect data and get a better understanding of the company’s process.
The Validation Lifecycle Approach
The revised guidance introduces the Validation Lifecycle Approach. This process looks at validation activities in three stages:
The Lifecycle Approach increases process understanding and control with a new emphasis on “scientific” rather than “documented” evidence. The revised guidance aligns process validation’s activities with a product lifecycle concept, as well as with existing FDA guidance to create synergy with International Conference on Harmonisation (ICH) guidance for industry, Q8 (rR2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
There are a number of key lifecycle principles that should be considered, in order to comply with the new FDA standards.
Key Lifecycle Principles:
- More emphasis on process development and defining boundaries.
- Utilize risk management as a tool to focus resources and define what is really critical to both patient and product.
- Better use of statistical tools to monitor and assess process performance.
- Establish a Community of Practices with Site SMEs throughout the division to share best practices, success stories, and make problems visible.
- Gain process knowledge and understanding throughout manufacturing until decommissioning/divestiture.
Overcoming Process Validation Staffing Challenges
While many larger companies are flourishing when it comes to the implementation of the Lifecycle Approach, it is proving problematic for small to midsize companies. Even some larger companies are struggling with it. The challenge stems from companies needing to change their existing culture and processes to meet the FDA expectations. Many companies simply cannot devote the necessary internal resources towards risk assessment, process understanding, and developing a risk-based process validation plan. In some instances, the need to outsource some or all of their process development and manufacturing activities arises and a staffing provider is needed for short-term consulting work or for longer on-going projects.
Specifically, when companies rely on old methodologies for candidate sourcing, they continue to lag behind in the development of robust systems to meet regulatory expectations. The most successful companies will be those who not only adapt with the new technologies, but invest in the right staffing solutions to fill resource needs.
It is critical to leverage the latest advancements in technologies and analytics in order to meet today’s complex staffing and workforce needs. The reality is, the validation industry should not only embrace these new technologies in its processes, but further determine how to best leverage it to source vital resources to meet changing market demands.
About the Author: Robert Wissert is a Business Development Manager at Yoh, A Day & Zimmermann Company. Robert has over 25 years within the pharmaceutical industry, and provides his clients with the resources possessing the proper skillsets to fulfill their organizational needs. He has a Six Sigma Black Belt from Villanova University and earned a bachelor’s degree from Immaculata University. Robert is currently pursuing a Master’s degree in Quality Assurance / Regulatory Affairs from Temple School of Pharmacy in Philadelphia.