Orientación práctica para el registro de API
Notas breves y orientadas a profesionales sobre cómo se registran y califican los APIs en los principales mercados — gratuitas para formuladores, solicitantes de registro y equipos de compras.
CEP (Certificate of Suitability): what it is and why it matters
A CEP certifies that an API's quality is suitably controlled by the European Pharmacopoeia monograph. For EU formulators it can replace a full ASMF review and dramatically shorten qualification.
EDMF / ASMF: the open part and the closed part explained
The EU Active Substance Master File splits into an Applicant's Part (open) and a Restricted Part (closed). Understanding the split is key to smooth API registration in Europe.
Written Confirmation for API imports into the EU
Since 2013, APIs imported into the EU from third countries need a Written Confirmation from the exporting authority — unless the country is on the equivalence list. Here is what exporters must know.
ICH Q7: the global GMP guideline for APIs
ICH Q7 is the international good manufacturing practice guideline for active pharmaceutical ingredients. It defines the quality system every serious API maker must run.
US DMF: registering an API with the FDA
A Type II Drug Master File lets an API manufacturer submit confidential manufacturing details to the FDA, which US formulators reference in their own applications.
Qualifying an API supplier: audit and documentation checklist
A practical checklist for procurement and QA teams qualifying a new API supplier — from GMP status and DMF/CEP files to on-site audits and supplier questionnaires.
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