Risk Management in Validation

Creating a Risk Priority Number (RPN) Matrix Template

Creating a Risk Priority Number (RPN) Matrix Template Creating a Risk Priority Number (RPN) Matrix Template The validation lifecycle in the pharmaceutical industry is a complex and detailed process governed by stringent regulatory requirements. Understanding and implementing a Risk Priority…

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…

How to Apply FTA in Utility and HVAC Risk Scenarios

How to Apply FTA in Utility and HVAC Risk Scenarios How to Apply FTA in Utility and HVAC Risk Scenarios In the pharmaceutical industry, validating processes is a critical step to ensure quality and compliance with regulatory requirements. One essential…

Regulatory Expectations for Using Risk Tools in Validation

Regulatory Expectations for Using Risk Tools in Validation Regulatory Expectations for Using Risk Tools in Validation Validation in the pharmaceutical and biopharmaceutical industries is essential to ensure product quality, efficacy, and safety. A robust validation process adheres to established guidelines…

Risk Assessment Formats Accepted by FDA and EMA

Risk Assessment Formats Accepted by FDA and EMA Risk Assessment Formats Accepted by FDA and EMA Step 1: Understanding the Context of Risk Assessment in Validation Risk assessment is an essential component of the pharmaceutical validation lifecycle, particularly in relation…

Writing SOPs for FMEA and HACCP in Pharma Facilities

Writing SOPs for FMEA and HACCP in Pharma Facilities Writing SOPs for FMEA and HACCP in Pharma Facilities This article provides a comprehensive step-by-step validation tutorial focusing on the essential aspects of SOP development for Failure Modes and Effects Analysis…

Linking Risk Assessment Outputs to Validation Protocols

Linking Risk Assessment Outputs to Validation Protocols Linking Risk Assessment Outputs to Validation Protocols Linking Risk Assessment Outputs to Validation Protocols – Practical guide for pharma professionals on iq oq and pq validation with GMP, FDA and EMA compliance. Step…

Common Mistakes in FMEA Risk Scoring and How to Fix Them

Common Mistakes in FMEA Risk Scoring and How to Fix Them Common Mistakes in FMEA Risk Scoring and How to Fix Them In the pharmaceutical industry, ensuring the quality and safety of products is paramount. This is where the product…

FMEA for Computer System Validation (CSV) Projects

FMEA for Computer System Validation (CSV) Projects FMEA for Computer System Validation (CSV) Projects: A Step-by-Step Guide Step 1: Understanding the URS and Risk Assessment Before embarking on any validation lifecycle, it is crucial to define clear User Requirements Specifications…

Risk Tools for Cleaning Validation in Multi-Product Plants

Risk Tools for Cleaning Validation in Multi-Product Plants Risk Tools for Cleaning Validation in Multi-Product Plants The pharmaceutical industry is characterized by stringent regulatory requirements that emphasize the importance of product and process validation. For multi-product plants, the challenge is…