Glossary
A Quality Technical Agreement (QTA) is a written agreement between parties involved in an outsourced pharmaceutical activity that defines their respective quality, GMP and/or GDP responsibilities, quality requirements and communication processes.
QTAs are commonly established between a Contract Giver and Contract Acceptor, for example between a pharmaceutical company and a contract manufacturer, laboratory, warehouse or logistics provider. EU GMP Chapter 7 requires outsourced GMP activities to be appropriately defined, agreed and controlled through a written contract specifying the responsibilities of each party.
A QTA typically covers:
- Roles and responsibilities, including testing, batch release and record retention
- Deviations, OOS investigations and CAPA
- Change control and regulatory notifications
- Complaints, recalls and quality-related communications
- Audits, inspections and subcontracting
- Documentation, records and data integrity
The QTA governs technical and quality requirements, whereas a Master Services Agreement (MSA) or Commercial Agreement generally defines the commercial and legal terms of the relationship.
A well-designed QTA helps prevent gaps in responsibility, supports regulatory compliance and strengthens control of outsourced activities throughout the product lifecycle. ICH Q10 similarly requires responsibilities and quality-related communication processes for outsourced activities to be defined in a written agreement.
Need to develop or review a Quality Technical Agreement?
Helix Life Sciences supports pharmaceutical and healthcare companies in establishing robust quality agreements for GMP, GDP, manufacturing, testing, distribution and other outsourced activities. Learn more about our Quality Management services.
