{"data":{"topics":[{"name":"Cleaning Validation","slug":"cleaning-validation","description":"A connected view of process design, qualification and continued control."},{"name":"HBEL & PDE","slug":"hbel-pde","description":"Health-based exposure limits and their role in cross-contamination risk assessment."},{"name":"MACO","slug":"maco","description":"Translating an exposure assessment into a justified carryover limit."},{"name":"Recovery","slug":"recovery","description":"Understanding what the sampling and analytical procedure can retrieve."},{"name":"Swab Sampling","slug":"swab-sampling","description":"Direct surface sampling, location selection and material compatibility."},{"name":"Rinse Sampling","slug":"rinse-sampling","description":"Sampling accessible and enclosed equipment through a justified rinse procedure."},{"name":"Worst Case","slug":"worst-case","description":"Selecting representative challenges and recording the limits of that representation."},{"name":"Visual Inspection","slug":"visual-inspection","description":"Making visual cleanliness an explicit, reproducible part of the control strategy."},{"name":"Hold Times","slug":"hold-times","description":"The intervals before cleaning and between cleaning and equipment reuse."},{"name":"Analytical Methods","slug":"analytical-methods","description":"Analytical suitability in the context of the residue and the acceptance criterion."},{"name":"Acceptance Criteria","slug":"acceptance-criteria","description":"Documented decisions about limits, measurement and acceptance."},{"name":"Shared Equipment","slug":"shared-equipment","description":"Connecting product characteristics, equipment and cross-contamination controls."},{"name":"Revalidation","slug":"revalidation","description":"Evaluating the effect of change on an established cleaning process."},{"name":"Microbial Control","slug":"microbial-control","description":"Considering microbial contamination alongside chemical residue risks."},{"name":"Detergents","slug":"detergents","description":"Cleaning-agent selection and the evidence supporting residue removal."}],"documents":[{"url":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","date":"2015-03-30","slug":"eu-gmp-annex-15","type":"GMP guideline","title":"EU GMP Annex 15: Qualification and Validation","status":"Current","version":"2015 revision","authority":"eu-gmp","effective":"2015-10-01","accessedAt":"2026-09-16","statusNote":"Provisional source status; 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