This QP-QP-agreement defines the formal division of responsibilities between a Qualified Person (QP) at a manufacturer located outside the EU and a Qualified Person at an EU-based importer and batch release site.
The agreement supports GMP-compliant batch certification and release into the European Union by clearly defining how responsibilities, oversight, documentation, and reliance between QPs are managed in accordance with EU GMP and EudraLex.
 
This document is professionally written and pre-filled (~95 % complete), requiring only company-specific information before execution.
Developed for companies operating third-country manufacturing models, the agreement establishes regulatory-compliant collaboration between QPs, covering manufacturing oversight, batch documentation, deviations, OOS handling, audits, and communication with EU authorities.
 
Includes:
• Clear GMP responsibility split between non-EU manufacturer and EU importer
• QP reliance principles according to EU GMP
• Batch certification and EU release requirements
• Documentation, archiving, and audit obligations
• Oversight of APIs, excipients, packaging, and finished products
• Structured appendices for products, sites, contacts, and regulatory confirmation
 
Why it matters:
When medicinal products are manufactured outside the EU and released inside the EU, regulators require a clearly defined QP-QP agreement. This template ensures inspection-ready documentation, regulatory clarity, and legally robust allocation of GMP responsibilities across borders.