Tag: iso cleanroom standards

KPI Template for Cleaning, Equipment, and Process Validation

KPI Template for Cleaning, Equipment, and Process Validation KPI Template for Cleaning, Equipment, and Process Validation The pharmaceutical industry places a strong emphasis on meeting regulatory requirements and ensuring product quality. To achieve this, professionals must undertake a systematic approach…

EMA and WHO Expectations for CPV Data Review

EMA and WHO Expectations for CPV Data Review EMA and WHO Expectations for CPV Data Review In the evolving landscape of pharmaceutical manufacturing, the regulatory framework guiding validation practices necessitates a robust understanding of the lifecycle approach to process validation.…

Annex 1 (2023 Revision) – Key Changes for Aseptic Validation

Annex 1 (2023 Revision) – Key Changes for Aseptic Validation Annex 1 (2023 Revision) – Key Changes for Aseptic Validation The recent updates to Annex 1 for the manufacturing of sterile medicinal products have significant implications for aseptic validation practices.…

When to Revalidate Based on Risk, Not Time

When to Revalidate Based on Risk, Not Time When to Revalidate Based on Risk, Not Time The pharmaceutical industry operates under rigorous standards to ensure product quality and patient safety. A critical component of this quality assurance process is validation,…

Writing a Risk Control Plan for Pharma Validation Projects

Writing a Risk Control Plan for Pharma Validation Projects Writing a Risk Control Plan for Pharma Validation Projects In the evolving landscape of pharmaceutical manufacturing, risk management has emerged as a cornerstone of quality assurance and validation processes. The implementation…

Elements of a Good Analytical Method Validation Protocol

Elements of a Good Analytical Method Validation Protocol Elements of a Good Analytical Method Validation Protocol Analytical method validation is an essential process within the pharmaceutical development lifecycle. As regulatory agencies such as the FDA and EMA continue to emphasize…

Pressure Drop Testing in Utility Distribution Lines

Pressure Drop Testing in Utility Distribution Lines Pressure Drop Testing in Utility Distribution Lines Pressure drop testing in utility distribution lines is a vital component of ensuring the integrity and functionality of cleanrooms within the pharmaceutical industry. This detailed tutorial…

Process Robustness in Pharmaceutical Manufacturing: A Complete Guide

Process Robustness in Pharmaceutical Manufacturing: A Complete Guide Process Robustness in Pharmaceutical Manufacturing: A Complete Guide Step 1: Understanding the User Requirements Specification (URS) and Risk Assessment Process validation begins with a clear understanding of the User Requirements Specification (URS).…