Insights
Guides for people who sign off suppliers
Regulatory and sourcing topics explained for procurement, QA and regulatory teams, with primary sources.
- 01
APIs · Regulatory · 7 min read ·
CEP or ASMF? How API documentation works in EU generic dossiers
A CEP is an EDQM certificate confirming that the Ph. Eur. monograph controls one manufacturer's substance. An ASMF is a confidential file the authority assesses with each application. Both support Module 3. Neither replaces the buyer's own checks on GMP, impurities and import papers.
- 02
Botanicals · Food safety · India · 7 min read ·
Ethylene oxide in Indian botanicals: what EU buyers test for in 2026
Ethylene oxide residues are measured as the sum of ethylene oxide and 2-chloroethanol. EU limits sit at the limit of quantification. As of October 2026, many Indian spices and botanical food-supplement ingredients still need an official certificate and lab report at the EU border.
- 03
APIs · Regulatory · India · 7 min read ·
Buying APIs from India: the EU document checklist
An API from India needs evidence of EU GMP, a CEP or ASMF, and a written confirmation from India's regulator. Each batch needs a specification and certificate of analysis. In Poland, the importer registers with GIF and follows EU GDP for active substances.
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