THE CLEANING VALIDATION KNOWLEDGE PLATFORM
Regulatory intelligence, structured references and visual guidance. Built around the questions you face in pharmaceutical manufacturing.
Recovery should be demonstrated for sampled contact materials and methods.
Follow the requirement from its primary source to sampling methods, audit questions and related guidance.
THREE WAYS TO FIND CLARITY
Find the requirement. Understand the context.
Make the connection to your work.
Know what deserves your attention. Selected developments, with their cleaning-validation relevance explained.
Follow developments →02Find requirements by authority, topic and source. Trace every entry back to the original document.
Search the Reference →03See how the concepts connect. Clear, practical explanations for learning and team discussions.
Explore the guides →REGULATORY WATCH
Regulatory Watch
PIC/S PI 058-1 interprets the revised EU GMP Annex 1 (2022). For cleaning validation the key points are chemical residue control in isolators and RABS, the separation of cleaning from bio-decontamination, and why VHP surface bio-decontamination is not automatically sterilisation.
Read the analysis
Deep Analysis
Two years of regulatory revision, enforcement, new standards, tighter analytics and a first serious statistics stack have moved cleaning validation out of the appendix and into the centre of GMP. Five developments define where the field stands in September 2026 — and each one changes something a programme owner has to decide.
Read the briefingDeep Analysis
At-line TOC, in-line UV and automated process capability monitoring are moving cleaning data from a laboratory result reported days later to a signal produced during the cycle. A close reading of what is proven, what standards actually require, and what remains a promising research proposal.
Read the briefing
Deep Analysis
Biologics degrade under cleaning, ADCs split one residue into antibody, linker, payload and conjugate, and peptide APIs combine high potency with methods already under strain. A synthesis of the local evidence on why toxicology, cleaning and detectability now move together.
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Deep Analysis
Visual inspection was present in every one of the cleaning findings FDA issued between 2024 and 2026 — never as the accused technique, always as the whole of the evidence. The distinction between a qualified visual method and a visual-only release decision is the difference between a control and an assumption.
Read the briefingREGULATORY REFERENCE
Recovery should be demonstrated for sampled contact materials and methods.
Sampling materials and extraction solvents can influence analytical results.
Rinse testing must meaningfully represent residues on equipment surfaces.
Analytical sensitivity and attainable recovery should support residue evaluation.
PRACTICAL GUIDANCE
VISUAL GUIDES
See how development, qualification and monitoring connect—and where change sends you back.
Connect the toxicological concept to a product-pair carryover assessment without confusing the values.
Choose a method for the question and the surface—not simply the easiest sample to collect.
A SPECIALIST PERSPECTIVE
Clean Validated is the English-language sister platform to the German cleaning-validation project sauber-validiert.de. A focused home for regulatory knowledge, practical education and the specialist book project.
About the platform ↗Explore the book project ↗
