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.
Why supplier qualification matters
Your API supplier's quality system becomes part of your product's quality story. Authorities and your own QA will hold you responsible for it. A structured qualification protects both patient safety and your marketing authorisation.
The documentation checklist
Collect and review, at minimum:
- GMP certificate(s) and latest inspection reports/outcomes.
- CEP, DMF or EDMF/ASMF reference numbers, versions and status.
- Written Confirmation if importing into the EU from a non-equivalent country.
- CoA, specification and methods for the API you intend to buy.
- Stability data, impurity profile, and residual-solvent data.
- Change-control policy — how you will be notified of changes.
- Site master file and organisation chart.
The supplier questionnaire
Most pharma companies send a producer questionnaire covering quality management, personnel, premises, equipment, documentation, production, QC and validation. Expect questions on:
- Data integrity and audit trails.
- Cross-contamination control and dedicated lines.
- Starting-material and solvent control.
- Deviation, CAPA, OOS and complaint handling.
- Sub-contracted operations.
The on-site audit
A GMP audit verifies the paperwork against reality:
- Opening meeting → scope and agenda.
- Site tour → warehouses, synthesis, purification, QC labs, utilities.
- Document review → batch records, SOPs, validation, training.
- Data integrity checks → electronic records, audit trails.
- Closing meeting → findings and CAPA plan.
How Oriental supports your qualification
We provide full documentation packages, complete producer questionnaires, and welcome on-site audits at our Shenzhen and Shandong Weifang sites. Our team has supported qualification by multinational pharma across the EU, North America and beyond.
This checklist is general guidance; adapt it to your QMS and the target authority's expectations.
Informazioni di carattere generale; non costituiscono consulenza legale o regolatoria. I requisiti cambiano — confermare sempre con l'autorità competente.
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