Cleaning Validation & Regulatory Intelligence Platform
Real-time regulatory tracking, risk analysis tools and technical documentation center for GMP compliance.
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Frequently used validation resources and guides.
What is Cleaning Validation?
Basic principles and introductory information.
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Local and international legal regulations.
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ISO, ASTM and industry standards.
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Newly opened regulations for comment.
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Implementation details and technical guides.
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Frequently asked technical questions and answers.
Draft Regulation Tracker
Last Updated: 12.10.2024EMA Q&A on Cleaning Validation - Revision 4
New questions and answers added on toxicological evaluations and the use of PDE values in limit determination. This revision includes updated guidance on HBEL implementation and analytical method validation requirements.
WHO Annex 3: Cleaning Validation Guidelines
Updated cleaning validation guidelines for global manufacturing standards. Published in the Official Journal with comprehensive guidance on equipment cleaning validation for pharmaceutical manufacturers operating under WHO GMP standards.
Process Validation: General Principles and Practices
FDA's guidance on process validation with lifecycle approach covering Stage 1 (Process Design), Stage 2 (Process Qualification), and Stage 3 (Continued Process Verification) for pharmaceutical manufacturers.
ICH Q9(R1): Quality Risk Management
Revised ICH Q9 guideline providing guidance on quality risk management principles and tools applicable throughout the pharmaceutical product lifecycle.
Regulation Comparison Module
Review old and new versions of Annex 15 side by side and automatically identify differences.
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Technical Articles & Latest News
Expert insights from leading GMP professionals.
Risk-Based Approach in Cleaning Validation: Strategy 2025
A comprehensive technical review of applying risk-based approaches in validation processes for pharmaceutical manufacturing.
Visual Inspection Limits: Objective Criteria for 'Visually Clean'
Standardization of visual inspection criteria and determination of acceptable limits in pharmaceutical equipment cleaning.
Annex 15 Revisions: Impact on Qualification and Validation
Analysis of how the latest changes in EU GMP Annex 15 affect operational processes for pharmaceutical manufacturers.
Monitored Regulatory Bodies & Agencies