Using CPV Outcomes to Trigger Revalidation or Tech Transfers Using CPV Outcomes to Trigger Revalidation or Tech Transfers Step 1: Understanding the Basics of Sterilisation Validation Sterilisation validation is a crucial aspect of the pharmaceutical manufacturing process, ensuring that products are free from viable microorganisms. The validation of sterilisation processes typically includes a thorough assessment of the sterilisation method employed, whether it be steam, dry heat, ethylene oxide, or another modality. Understanding the principles of each method is essential for QA professionals tasked with maintaining compliance with regulations set forth by organizations such as the FDA and EMA. Each sterilisation…

CPV Template and Checklist for QA Teams CPV Template and Checklist for QA Teams Continued Process Verification (CPV) is a critical component of process validation within the pharmaceutical industry. Emphasized by regulatory guidelines such as the FDA Process Validation Guidance and EU GMP Annex 15, CPV ensures that processes remain in a state of control throughout their lifecycle. This article serves as a comprehensive step-by-step tutorial to assist QA, QC, Validation, and Regulatory teams in implementing sterilization validation protocols effectively. Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The journey of any validation process begins with a clear…

How to Present CPV Data During Regulatory Audits How to Present CPV Data During Regulatory Audits In the current regulatory landscape, the pharmaceutical industry faces stringent scrutiny regarding the implementation and effectiveness of Continued Process Verification (CPV) programs. This article provides a comprehensive, step-by-step guide on how to present CPV data effectively during regulatory audits, specifically in the context of sterilization validation, ensuring compliance with guidelines from the FDA, EMA, and ICH. Step 1: Establishing User Requirement Specifications (URS) & Risk Assessment The foundation of any successful validation effort begins with a well-defined User Requirement Specification (URS). The URS defines…

CPV and OOS/OOT Events: Investigation Flow and Records CPV and OOS/OOT Events: Investigation Flow and Records In the pharmaceutical industry, Continued Process Verification (CPV) and the effective management of Out of Specification (OOS) and Out of Trend (OOT) events are integral for ensuring product quality and compliance with regulatory expectations. This comprehensive, step-by-step tutorial delves into the critical aspects of CPV, focusing on the necessary investigation flows and record management that align with FDA, EMA, and ICH guidelines. It is aimed at QA, QC, and Validation teams, ensuring a robust understanding of best practices and regulatory requirements. Step 1: Understanding…

Building Dashboards for CPV Visualization (Excel + Power BI) Building Dashboards for CPV Visualization (Excel + Power BI) Continued Process Verification (CPV) is a critical aspect of process validation that ensures that processes remain in a state of control throughout the product lifecycle. This article provides a step-by-step tutorial on how to build dashboards for CPV visualization using tools such as Excel and Power BI, aligning with regulatory requirements and expectations set forth by organizations like the FDA and EMA. Step 1: Understanding the Fundamentals of CPV Before embarking on the journey of building dashboards for CPV visualization, it is…

Handling Process Variability Identified in CPV Handling Process Variability Identified in CPV Step 1: Understanding the Role of Continued Process Verification (CPV) Continued Process Verification (CPV) is an essential aspect of process validation, ensuring that a manufacturing process remains in a state of control throughout its lifecycle. Following the guidelines outlined in FDA’s Process Validation Guidance, CPV requires the implementation of systematic monitoring of process parameters and product quality attributes, providing insight into ongoing consistency and reliability. The primary objective of CPV is to identify and manage variability that may arise during normal operations. Variability can stem from several sources,…

How to Trend Process Parameters Across Lots for CPV How to Trend Process Parameters Across Lots for CPV Continued Process Verification (CPV) is an essential component of the pharmaceutical validation lifecycle that ensures processes remain in a state of control over time. The integration of computerized systems into this process allows for efficient data management and analysis. This guide will walk validation professionals through the steps required to trend process parameters across lots effectively, ensuring that all activities comply with FDA guidelines for computer system validation (CSV), EMA, and Good Manufacturing Practices (GMP). Step 1: Understanding User Requirements Specification (URS)…

Role of LIMS and QMS in CPV Automation Role of LIMS and QMS in CPV Automation In the pharmaceutical and biologics sectors, compliance with strict regulatory standards is crucial for quality assurance and product integrity. Continued Process Verification (CPV) plays a pivotal role in ensuring that processes remain in a state of control post-licensure. This article outlines a step-by-step tutorial on the validation lifecycle, with a focus on the integration of Laboratory Information Management Systems (LIMS) and Quality Management Systems (QMS) in automating CPV. The tutorial adheres to the FDA Guidelines for Process Validation, EU GMP Annex 15, ICH Guidelines…

Linking CPV to Product Quality Complaints and Deviations Linking CPV to Product Quality Complaints and Deviations Continued Process Verification (CPV) is integral to ensuring consistent product quality throughout the product lifecycle. This tutorial provides a comprehensive, step-by-step guide on how to properly implement CPV, linking it to computer systems validation, product quality complaints and deviations. Adhering to best practices outlined by agencies such as FDA and the European Medicines Agency (EMA) is essential for pharmaceutical professionals. Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation for any validation effort lies in clearly defined user requirements specifications (URS)….

CPV Review Frequency: Monthly, Quarterly, or Annually? CPV Review Frequency: Monthly, Quarterly, or Annually? Continued Process Verification (CPV) is an essential component of a robust pharmaceutical validation strategy, ensuring the consistent quality of products in line with FDA Process Validation Guidance and EU GMP Annex 15. This article provides a comprehensive, step-by-step validation tutorial, detailing the key stages of the validation lifecycle, including process design, qualification, Performance Qualification (PQ), Continued Process Verification (CPV), and revalidation. By aligning with global regulatory standards such as ICH Q8-Q10, ICH Q9, and Part 11, this article serves as a practical guide for QA, QC,…