Free tool

Which Guidelines Apply to Your Operation?

A decision tree that takes you from what you make and which markets you supply to the specific ICH and GMP guidelines that actually apply — so you stop guessing which rulebook you are building to.

What’s inside

  • ·The always-on core — the ICH guidelines (Q10 quality system, Q9 risk, Q8 development) that apply to every operation
  • ·Step 1 — product class — finished drug, active substance / API (incl. cannabis extract), botanical starting material, supplement, or food/beverage → your primary GMP regime
  • ·Step 2 — your markets — US, EU/UK export, or both, and what each adds (EU GMP, the Qualified Person, GDP)
  • ·Step 3 — attribute triggers — sterile, shelf-life, in-house methods, residual solvents, heavy metals, computerized systems, accreditation, lifecycle — each switching on its guideline
  • ·A one-page flowchart plus the matrix tables, so you can collect your full applicable set in minutes

The strategy behind it is in the companion essay, “ICH Is the Bridge to EU GMP” — why building to ICH once gets you to the bar every European market enforces.

Branded PDF (decision matrix + flowchart). By Intrepid Scientific. An orientation aid, not regulatory advice.

Send it to me

We’ll email you the PDF right now and nothing else unless you ask.