Free White Paper

The Scientific Foundation of Compliant, Profitable Shared Manufacturing

In a shared pharmaceutical facility, a single miscalculated cleaning limit can trigger an FDA 483 observation, halt production, or force the costly dedication of equipment worth millions. This white paper explains exactly how a PDE is derived — and why it matters far more than most manufacturers realise.

UKRT- & ERT-Certified Authors
Qualified toxicologists

ICH & EMA Methodology
Regulatory-grade science

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Inside the White Paper

What You Will Learn

  • PDE, ADE & ADI Defined — How PDE, ADE, and ADI differ — and which metrics regulators actually require.
  • The ICH PDE Methodology — The step-by-step ICH methodology behind a defensible PDE calculation, including the five uncertainty factors (F1–F5) and when additional Modifying Factors apply.
  • MACO & Your Cleaning Programme — How Maximum Allowable Carryover (MACO) is directly linked to your PDE — and why a poorly derived value collapses your entire cleaning validation programme.
  • The Over-Conservative Trap — How stacking unnecessary uncertainty factors produces an artificially low PDE that makes compliant manufacturing operationally impossible.
  • The Full Regulatory Landscape — EMA HBEL Guideline, ICH Q3C/Q3D, ISPE Risk-MaPP, and ICH Q9 — the standards that govern your obligations.


Who Should Read This

QA/QC managers and heads of regulatory affairs responsible for cleaning validation strategies, as well as manufacturing directors seeking to optimise shared facility operations without compromising audit readiness.

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