Establishment of Cleaning Validation Acceptance Criteria

What this document is for

This procedure mandates a rigorous, science-based approach to establishing cleaning validation acceptance criteria, a critical requirement for preventing cross-contamination and ensuring patient safety in shared manufacturing environments.

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Ships as

Grounded in

FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.

Other Validation documents

• Airflow Visualization and Cleanroom Qualification
• Commissioning, Qualification, and Validation Governance
• Disinfectant and Sanitizer Efficacy Qualification
• Drug Product Component Compatibility and Qualification
• Environmental Monitoring Performance Qualification (EMPQ) of Classified Areas
• Incoming Quality Control (IQC) AQL Verification
• Periodic Product Quality Evaluation (PPQE)
• Periodic Qualification Evaluation and Requalification