This document is intended to give guidance on auditing manufacturers of registered starting materials.
Contract between Auditor and the API Compliance Institute.
Agreement on audit execution between customer, auditee, auditors and API Compliance Institute.
Secrecy Agreement between customer, auditee, auditors and API Compliance Institute.
Standardised Letter to the Manufacturing Authorisation Holder
Standardised Letter to the API Manufacturer
Standardised Letter from the API Manufacturer to his customer
Feedback form for auditee regarding audit performance
This document provides standards for audits in Excipients production sites
This document describes standards for Good Distribution Practice Audits of pharmaceutical excipients.
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