Tag: Risk Management in Validation

Using Risk Ranking to Prioritize Validation Projects

Using Risk Ranking to Prioritize Validation Projects Using Risk Ranking to Prioritize Validation Projects In the pharmaceutical and biopharmaceutical industries, effective validation practices are pivotal to ensuring product quality and compliance with regulatory standards. This article offers a comprehensive, step-by-step…

Defining Critical vs Non-Critical Equipment for Validation

Defining Critical vs Non-Critical Equipment for Validation Defining Critical vs Non-Critical Equipment for Validation This article serves as a comprehensive guide for pharmaceutical professionals in the realm of instrument validation, defining critical versus non-critical equipment within the context of GMP…

Risk Ranking Matrix Template for QA/QC Applications

Risk Ranking Matrix Template for QA/QC Applications Risk Ranking Matrix Template for QA/QC Applications In the pharmaceutical industry, quality assurance (QA) and quality control (QC) teams must diligently evaluate risks associated with processes, instruments, and methods. One particularly essential technique…

How to Perform Criticality Assessment in Pharma Validation

How to Perform Criticality Assessment in Pharma Validation How to Perform Criticality Assessment in Pharma Validation The pharmaceutical industry is governed by a strict regulatory framework that ensures product quality and patient safety. One critical aspect of this framework is…

How to Present Risk Analysis During Regulatory Inspections

How to Present Risk Analysis During Regulatory Inspections How to Present Risk Analysis During Regulatory Inspections Step 1: Understanding User Requirements Specification (URS) and Risk Assessment Before initiating any validation project, it is crucial to establish a comprehensive User Requirements…

Real-World Deviations Traced Back Through FTA Models

Real-World Deviations Traced Back Through FTA Models Real-World Deviations Traced Back Through FTA Models In the pharmaceutical industry, ensuring consistent quality of products is paramount. Understanding the complexities of validation processes, especially within the context of deviations, is critical. This…

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…

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…

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…

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…