A Quality Agreement (QA) is the written document that defines quality responsibilities between a pharmaceutical manufacturer and its customer (distributor, MAH, tender buyer). It is essential - yet often overlooked until a quality event reveals the gap.
1. What the QA Defines #
- Product scope and specifications
- Manufacturer and customer responsibilities
- Change control notification and approval
- Deviation and complaint handling
- Batch release responsibilities
- Stability commitments and data sharing
- Pharmacovigilance interface
- Recall procedures
- Audit rights
- Data integrity expectations
- Subcontractor / supplier management
- Retention period for records
2. Why It Matters #
- Clarifies who does what - preventing gaps in quality events
- Required by regulators as part of MAH / distributor oversight
- Essential for customer audits to assess scope
- Basis for commercial dispute resolution when quality issues arise
3. Key Clauses to Negotiate Carefully #
- Change notification timing - typical 30 / 60 / 90 days depending on change classification
- Complaint response time - acknowledge within defined business hours; investigation complete within defined weeks
- Audit rights - typically once per year routine + for-cause
- PV timelines - reporting to regulators within 24 hours (serious) / 15 days (non-serious)
- Recall - decision authority, mock recall participation, notification chain
4. Common Pitfalls #
- Boilerplate QA with no product-specific customisation
- Ambiguous batch-release responsibility
- Missing data-integrity / ALCOA+ clauses
- Undefined subcontractor / API-supplier oversight
- Term mismatch with Supply Agreement
5. Lifecycle Management #
The QA should be reviewed annually or at any significant event (regulatory change, product transfer, quality issue). Updates follow formal change control.
6. Taj Pharma Approach #
We sign Quality Agreements with all distributor and strategic-supply partners. Template QA is available for review under CDA.