Continued process verification (CPV) and annual product review (APR) practices are crucial for maintaining a state of control and identifying continuous improvement initiatives in the pharmaceutical and biological industries. Regulators also require both practices.
However, while many companies have modeled their CPV reporting on the APR reporting process, the two practices are often not fully integrated, leading to inefficiencies. For example, reporting periods are not aligned, data acquisition uses manual data-entry systems and APR workflows do not leverage information from CPV workflows.
Initial implementations may also have focused primarily on compliance rather than efficiency and CPV regulations are vaguely worded, leaving them open to interpretation. Additionally, APR practices are often well-established and firmly embedded, making it difficult to incorporate any new CPV processes.
This is why BioPhorum has published A guide to integrating CPV reporting and APR practices , which presents opportunities to improve and align the two activities. It also gives a vision for a future state incorporating elements of digital transformation, business processes, informatics, knowledge management and departmental relationships.
Digital transformation in manufacturing will ultimately leverage real-time data reviews and optimize efficiencies between APR and CPV practices. Until then, the proposals in this paper offer significant steps in the right direction.
Integration is complex because it bridges two worlds in biopharmaceuticals – CPV is usually owned by manufacturing while APR is usually managed by quality departments, leading to duplicated effort in data collection and reporting. This creates an implementation challenge, so the paper also gives recommendations for a transition path from the current to the future state by reducing the duplication of resources invested in CPV reporting and APR.
“The use of a well-designed validated informatics system that includes automated reporting has the potential to be a game-changer for CPV,” said Carly Cox, Senior Process Informatics Manager at Pfizer. “By automating the collection, organization, analysis, and reporting of manufacturing data, companies can catch issues faster and spend more time resolving those issues and improving the processes.”
Some of the recommendations for companies transitioning towards a fully digital solution include equipment automation and feedback control, implementing validated trending tools and centralizing trending reports via web-based interactive platforms.
The paper draws on the experiences of more than 20 biopharmaceutical manufacturing companies in creating CPV and APR reports. It will help reduce non-value-added reporting activities, eliminate duplicate work and inconsistencies between CPV and APR, and ensure compliance with regulatory requirements with reduced effort.
By making reporting less time-consuming, more time is available to proactively monitor processes and quickly act upon any signals found. This can lead to solving issues and improving processes more quickly, with fewer batches being negatively impacted.
“An optimal informatics system with appropriate data analysis and reporting capabilities can be a force-multiplier for both new and existing CPV business processes in streamlining and automating the timely access to validated data and analysis results,” said Sivashankar Sivakollundu, Associate Director at Bristol-Myers Squibb. “These capabilities can significantly improve the quality and business value of a CPV program. From a knowledge management standpoint, such integrated informatics systems can enhance the holistic understanding of various manufacturing processes of an organization and improve the efficiency of its fault response and continuous improvement efforts.”
This is the fifth in a series of papers focusing on CPV and builds on the foundations created in an industry position paper with an example plan, the validation of informatics systems, legacy products and signal responses in biopharmaceuticals.