Tag: iso 17665

Year-over-Year Comparison of Validation Effectiveness

Year-over-Year Comparison of Validation Effectiveness Year-over-Year Comparison of Validation Effectiveness This article serves as a practical guide for pharmaceutical professionals looking to align their validation processes with regulatory standards and drive continuous improvement. The focus is particularly on ISO 17665…

Using Trend Data to Improve Validation Processes

Using Trend Data to Improve Validation Processes Using Trend Data to Improve Validation Processes This comprehensive tutorial will guide pharmaceutical professionals through the essential steps of validating processes, with a specific emphasis on utilizing trend data for continuous improvement. Our…

How to Review CPV Data: Roles of QA, QC, and Manufacturing

How to Review CPV Data: Roles of QA, QC, and Manufacturing How to Review CPV Data: Roles of QA, QC, and Manufacturing Continued Process Verification (CPV) has become an essential element of modern pharmaceutical manufacturing as it reinforces the consistent…

CPV Report Template: Sections, Graphs, and Data Requirements

CPV Report Template: Sections, Graphs, and Data Requirements CPV Report Template: Sections, Graphs, and Data Requirements Continued Process Verification (CPV) is an essential component in the lifecycle of pharmaceutical manufacturing, focusing on the ongoing monitoring of the process to ensure…

PQ of Aseptic Filling Lines: What to Include

PQ of Aseptic Filling Lines: What to Include PQ of Aseptic Filling Lines: What to Include Process qualification (PQ) of aseptic filling lines is a critical requirement for ensuring the sterility and safety of pharmaceutical products. This comprehensive article provides…

Aseptic Process Validation: Qualification Strategy Overview

Aseptic Process Validation: Qualification Strategy Overview Aseptic Process Validation: Qualification Strategy Overview Aseptic process validation is crucial for ensuring the safety and efficacy of pharmaceutical products, particularly those administered via injection or infusions. This comprehensive tutorial outlines the necessary steps…

How to Write a Revalidation Protocol After Change Control

How to Write a Revalidation Protocol After Change Control How to Write a Revalidation Protocol After Change Control In the pharmaceutical and biotechnology industries, validation is a critical process for ensuring product quality, safety, and compliance with regulatory standards. After…

QA Responsibilities in Revalidation and Change Approval

QA Responsibilities in Revalidation and Change Approval QA Responsibilities in Revalidation and Change Approval In the pharmaceutical and biologics industries, revalidation and change approval are critical components of ensuring product quality and compliance. These activities require a systematic approach that…

Designing a Risk-Based Cleaning Validation Program

Designing a Risk-Based Cleaning Validation Program Designing a Risk-Based Cleaning Validation Program In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination in manufacturing processes is of utmost importance. Cleaning validation plays a crucial role in ensuring that these processes are…

What Is a Risk-Based Validation Approach?

What Is a Risk-Based Validation Approach? What Is a Risk-Based Validation Approach? Pharmaceutical process validation is essential to ensure that products are of the required quality, safety, and efficacy. The use of a risk-based validation approach aligns with regulatory expectations,…