Global perspectives on CPV requirements across FDA, EMA and MHRA Global perspectives on CPV requirements across FDA, EMA and MHRA The landscape of pharmaceuticals is continually evolving, necessitating a stringent approach to regulatory compliance. Among the key aspects in this realm is continued process verification (CPV), a crucial part of the manufacturing lifecycle of medicinal products. This regulatory explainer manual delves into CPV from a global perspective, addressing the expectations set by the FDA, EMA, and MHRA. It serves as a comprehensive guide for regulatory affairs professionals in the pharma and biotech sectors. Regulatory Affairs Context Regulatory Affairs (RA) professionals…

Digital Tools and Dashboards for CPV Evidence in eCTD Packages Digital Tools and Dashboards for Continued Process Verification Evidence in eCTD Packages Continued Process Verification (CPV) is an essential approach to ensuring continuous control of manufacturing processes and consistent quality of pharmaceutical products. With regulatory agencies such as the FDA, EMA, and MHRA increasingly emphasizing the importance of CPV and ongoing process monitoring, the adoption of digital tools and dashboards has become crucial for regulatory submissions, particularly in eCTD packages. This article serves as a comprehensive guide for regulatory affairs professionals to understand the nuances of CPV, the regulatory landscape,…

Updating CPV Strategies as Part of Post-Approval Change Filings Updating CPV Strategies as Part of Post-Approval Change Filings Continued Process Verification (CPV) plays a crucial role in the regulatory landscape surrounding pharmaceutical manufacturing and its quality assurance. As the industry embraces a Quality by Design (QbD) approach, understanding how to adapt CPV strategies post-approval is vital for ensuring therapeutic product efficacy and safety. This regulatory explainer manual provides an in-depth look into the expectations of regulatory agencies such as the FDA, EMA, and MHRA regarding CPV, especially in the context of regulatory submissions like New Drug Applications (NDAs), Abbreviated New…

Linking CPV Insights to Control Strategy Refinement in CMC Sections Linking CPV Insights to Control Strategy Refinement in CMC Sections Continued Process Verification (CPV) is a critical component in the lifecycle management of pharmaceutical products. By integrating CPV insights into control strategy refinement, regulatory affairs professionals ensure compliance with regulatory expectations while enhancing product quality and process efficiency. This article serves as a regulatory explainer manual for Kharma and regulatory professionals, focusing on the intersection of CPV with Chemistry, Manufacturing, and Controls (CMC), its implications across various jurisdictions, and practical guidelines for documentation and regulatory submissions. Regulatory Context The concept…

Audit readiness of CPV documentation for inspections and dossier review Audit readiness of CPV documentation for inspections and dossier review The field of Regulatory Affairs (RA) plays a pivotal role in ensuring that pharmaceutical and biotech products not only comply with necessary regulations but also maintain a high standard of quality throughout their lifecycle. Among the various components of RA, Continued Process Verification (CPV) and Ongoing Process Monitoring (OPM) are critical for demonstrating product consistency and quality over time. This article serves as a comprehensive regulatory explainer manual for audit readiness of CPV documentation, focusing on salient guidelines, agency expectations,…