GMP Quality Agreements

A ready-to-use process for negotiating, approving, and maintaining Quality Agreements with your GMP and GDP vendors — plus two detailed appendices covering exactly what belongs in a strong agreement.

Who it's for: Virtual sponsors negotiating or managing Quality Agreements (QAg/QTA) with contract manufacturers, laboratories, and distribution vendors.

What's included:

• Full procedure for initiating, negotiating, and approving new Quality Agreements
• Revision, periodic review (every 3 years), breach, and termination procedures
• Appendix 1: Suggested Elements of a Quality Agreement — a comprehensive checklist covering regulatory requirements, audit provisions, production, stability, and materials management
• Appendix 2: GMP IT Vendor Quality Agreement elements, including Part 11 / Annex 11 compliance requirements

Format: Fully editable Word document (.docx).

Regulatory alignment: References ICH Q7 and 21 CFR Part 11 / EU Annex 11 requirements for electronic records and signatures.