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From GACP to EU GMP

For producers supplying EU GMP buyers

EU buyers ask their suppliers where GMP starts in the supply chain, and EU GMP leaves that decision to the manufacturer, who has to designate the point, document it and give the reason. We map that point with you, step by step, and prepare your sites for the buyer’s audit.

What you receive

  • The GMP starting point, documented with its rationale
  • A risk assessment to ICH Q9
  • A list of what to fix before the buyer’s audit

What we do

  • GACP and GMP boundary mapping
  • Supply chain step review
  • Quality risk assessment to ICH Q9
  • Drying and trimming readiness
  • Non-EU grower qualification
  • Preparation for EU buyer audits

How it runs

  1. 01

    Supply Chain Review

    We follow your material from harvest to shipment and record what happens at each step and who does it.

  2. 02

    Boundary Mapping

    We mark where GACP ends and GMP begins, reading GACP, Annex 7 and Part II of EU GMP together.

  3. 03

    Risk Assessment

    We write the rationale for that point with the ICH Q9 risk method, in a file a buyer or an inspector can read.

  4. 04

    Drying & Trimming

    We check drying and trimming against the requirements that apply to them, since a German authority has already read drying as a critical manufacturing step.

  5. 05

    Non-EU Growers

    If you buy from growers outside the EU, we qualify them against what your EU buyer will audit.

  6. 06

    Buyer Audit Preparation

    We prepare your team and your documents for the audit of your EU buyer.