Navigating ANVISA’s Cleaning Validation Requirements — with a Spotlight on Solubility Criteria —

If you're preparing for an ANVISA inspection—or simply raising the bar on your global GMP strategy—Brazil’s National Health Surveillance Agency (ANVISA) demands more than just a clean facility. They expect science-backed, risk-based cleaning validation that stands up to scrutiny. Here’s how to build it, step by step:

🏛️ Know Your Regulations

Start by anchoring your program in ANVISA’s key resolutions:
  • RDC 301/2019 – General GMP requirements
  • RDC 658/2022 – GMP for imported APIs & products
  • RDC 166/2017 – Analytical method validation
  • PIC/S PE 009 – Globally aligned guidance (accepted as justification)

📋 Essentials for Your Cleaning Validation File

  1. Master Validation Plan (MVP) – Scope, timelines, roles, revalidation triggers
  2. Product & Process Risk Mapping – Identify worst-case actives & solubility flags
  3. Solubility in Risk Assessment – If it won’t dissolve, it won’t be removed
  4. Solubility-Focused Cleaning Protocols – Design cleaning steps around dissolving power
  5. Swab/Rinse Method Validation – Prove recovery, especially for sticky APIs
  6. Solubility Tables – Document compound solubilities (solvent, pH, temp)
  7. Limit Justification – Use low solubility as the baseline for your thresholds
  8. Equipment & Facility Complexity – Highlight hard-to-clean zones
  9. Procedure Definition – Every step, every chemical—justify by solubility
  10. Sampling Strategy – Worst-case swab points, rinse volumes, inspection zones
  11. Analytical Documentation – Method specificity, recovery ≥ 90%, matrix precision
  12. Acceptance Criteria – µg/cm², ppm, or HBEL—tied to solubility and toxicity
  13. Execution Records – Logs, chromatograms, TOC data, deviations
  14. Supporting Docs – SOPs, detergent CoAs, calibration data
  15. Training & Change Control – Operator readiness and revalidation triggers

Final Thoughts

If your cleaning validation file isn’t talking about solubility, worst-case residues, and RDC 301/2019—you’re not inspection-ready. But if it is, you’re not just compliant… you’re benchmark-setting.

395 thoughts on “Navigating ANVISA’s Cleaning Validation Requirements — with a Spotlight on Solubility Criteria —”

  1. Estralabet, not bad at all! Lots of different games and the bonus offers are decent. Could use a little sprucing up, but overall a solid experience. See for yourself: estralabet

  2. Enter your invite code to earn your airdrop on Aster https://is.gd/ZceEI6

  3. Ryder1691 January 20, 2026

    Claim Your Exclusive Bonus on AsterDEX https://is.gd/CGTnqR

Add a Comment

Your email address will not be published.