Tag: FDA guidelines

Visual Inspection Criteria Specific to Shared Facility Cleaning

Visual Inspection Criteria Specific to Shared Facility Cleaning Visual Inspection Criteria Specific to Shared Facility Cleaning In the pharmaceutical and biologics industries, effective cleaning processes are crucial to ensure product quality and compliance with regulatory standards. This step-by-step validation tutorial…

Validation Strategy Based on System Criticality Assessment

Validation Strategy Based on System Criticality Assessment Validation Strategy Based on System Criticality Assessment Validation in the pharmaceutical industry is paramount to ensuring product quality and patient safety. This comprehensive guide will outline the step-by-step validation lifecycle including process design,…

Differences in Validating Non-Compendial vs Compendial Water

Differences in Validating Non-Compendial vs Compendial Water Differences in Validating Non-Compendial vs Compendial Water In the pharmaceutical industry, ensuring the quality of water systems—whether compendial or non-compendial—is critical for product safety, efficacy, and compliance with regulatory standards. This article provides…

Audit Failures Related to Shared Equipment Cleaning: Lessons Learned

Audit Failures Related to Shared Equipment Cleaning: Lessons Learned Audit Failures Related to Shared Equipment Cleaning: Lessons Learned 1. Understanding User Requirements Specification (URS) & Risk Assessment The initial step in the validation lifecycle for cleaning shared equipment in the…

GAMP 5 vs GAMP 4: Key Differences for Validation Teams

GAMP 5 vs GAMP 4: Key Differences for Validation Teams GAMP 5 vs GAMP 4: Key Differences for Validation Teams The validation lifecycle in pharmaceutical and biologics manufacturing is critical to ensuring compliance with regulatory expectations such as FDA Process…

PQ Testing Schedule for Newly Installed Water Loops

PQ Testing Schedule for Newly Installed Water Loops PQ Testing Schedule for Newly Installed Water Loops The validation lifecycle for newly installed water loops is critical to ensure compliance with regulatory standards and operational effectiveness. This article aims to provide…

Documentation Best Practices for Multi-Product Equipment Cleaning

Documentation Best Practices for Multi-Product Equipment Cleaning Documentation Best Practices for Multi-Product Equipment Cleaning In the biopharmaceutical industry, ensuring the efficacy and safety of products is paramount. A vital cog in this wheel is the process validation in manufacturing of…

How to Classify Systems Using GAMP 5 Categories

How to Classify Systems Using GAMP 5 Categories How to Classify Systems Using GAMP 5 Categories Step 1: Understanding GAMP 5 Framework The GAMP 5 framework lays the foundation for effective computer system validation (CSV) in the pharmaceutical industry. It…

Regulatory Audit Observations on Water System Validation

Regulatory Audit Observations on Water System Validation Regulatory Audit Observations on Water System Validation 1. Understanding the User Requirement Specification (URS) and Risk Assessment In the pharmaceutical industry, the development of a water system for purposes such as producing Water…

Using Multipliers for Worst-Case Selection in Shared Lines

Using Multipliers for Worst-Case Selection in Shared Lines Using Multipliers for Worst-Case Selection in Shared Lines In the pharmaceutical and biopharmaceutical manufacturing sectors, ensuring compliance with regulatory standards is paramount. One of the critical aspects of compliance includes the validation…