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"The Essential Risk‑Based Cleaning Validation Checklist: Ensure Compliance, Strengthen Controls, and Align with Global Regulatory Expectations"

Pharmaceutical manufacturers face increasing expectations to justify cleaning programs using modern, risk-based validation principles. Regulators now expect scientifically supported decisions that align with global standards, including Annex 15 and ASTM E3106. The Risk-Based Cleaning Validation Checklist helps teams quickly assess whether their approach meets today’s requirements.

Many legacy programs rely on outdated assumptions, lack clear rationale, or fail to consider key factors like equipment risk, sampling strategy, residue hazards, or operator variability. The checklist provides a structured way to identify gaps and strengthen documentation, justification, and scientific support.

A risk-based approach not only satisfies regulators but improves consistency, reduces deviations, and ensures cleaning processes protect against contamination. It guides teams in evaluating worst-case residues, equipment design, and hardest-to-clean surfaces to build a defensible, data-driven strategy.

The checklist also reinforces cross-functional collaboration: bringing together manufacturing, quality, engineering, and analytical teams to assess facility design, equipment configuration, and analytical methods. Regulators expect analytical techniques and hold-time studies to be scientifically justified, sensitive, and well-documented.

Used proactively, the checklist strengthens audit readiness by highlighting vulnerabilities such as missing rationale, unclear sampling locations, or incomplete documentation. It

helps manufacturers modernize cleaning validation, reduce compliance risks, and build more robust, defensible programs.

Download the Checklist to Learn:

• How to determine whether your cleaning validation approach is grounded in risk-based decision-making.
• Whether limits, sampling strategies, and analytical methods align with modern regulatory expectations.
• How to assess equipment, processes, and facility design using structured risk assessments.
• How to distinguish critical vs. non-critical cleaning parameters and ensure lifecycle coverage scientifically justified.

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