Tag: cleanroom validation

Tracking Validation Deviations and CAPAs as Metrics

Tracking Validation Deviations and CAPAs as Metrics Tracking Validation Deviations and CAPAs as Metrics Validation is a critical part of pharmaceutical quality assurance, ensuring that processes reliably produce products that meet predetermined specifications and quality attributes. This article provides a…

Building a CPV Matrix by Product, Process, and Equipment

Building a CPV Matrix by Product, Process, and Equipment Building a CPV Matrix by Product, Process, and Equipment In the pharmaceutical industry, Continued Process Verification (CPV) is critical for ensuring the ongoing quality and integrity of products throughout their lifecycle.…

Media Fill for Manual vs Automated Filling Lines

Media Fill for Manual vs Automated Filling Lines Media Fill for Manual vs Automated Filling Lines Media Fill for Manual vs Automated Filling Lines – Practical guide for pharma professionals on cleanroom validation with GMP, FDA and EMA compliance. Step…

When to Perform Full vs Partial Revalidation

When to Perform Full vs Partial Revalidation When to Perform Full vs Partial Revalidation In the pharmaceutical and biologics industries, the integrity of manufacturing processes is paramount. As part of the validation lifecycle, understanding when to perform full versus partial…

Case Studies on FMEA Implementation in Equipment Qualification

Case Studies on FMEA Implementation in Equipment Qualification Case Studies on FMEA Implementation in Equipment Qualification In the pharmaceutical industry, ensuring the integrity and effectiveness of cleanroom facilities is paramount. The implementation of Failure Modes and Effects Analysis (FMEA) during…

Linearity Range Determination Using Regression Analysis

Linearity Range Determination Using Regression Analysis Linearity Range Determination Using Regression Analysis In the pharmaceutical industry, ensuring the accuracy and reliability of analytical methods is crucial for maintaining compliance with regulatory agencies such as the FDA and EMA. This detailed…

Writing an HVAC Qualification Protocol (IQ, OQ, PQ)

Writing an HVAC Qualification Protocol (IQ, OQ, PQ) Writing an HVAC Qualification Protocol (IQ, OQ, PQ) The HVAC system in pharmaceutical manufacturing is critical to maintaining the integrity of cleanroom environments. This comprehensive guide outlines the step-by-step process for developing…

Holding Time Validation in Pharmaceutical Manufacturing: A Complete Guide

Holding Time Validation in Pharmaceutical Manufacturing: A Complete Guide Holding Time Validation in Pharmaceutical Manufacturing: A Complete Guide Step 1: Understanding the Importance of Holding Time Validation Holding time validation is a crucial aspect of pharmaceutical manufacturing that ensures the…

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy How to Validate Cleanrooms and Perform Microbiological Risk Assessment in Pharma Introduction Cleanroom validation and microbiological risk assessment are essential components of any GMP-compliant pharmaceutical facility. Cleanrooms support critical manufacturing environments…