Observation:
Quality agreements missing with contract manufacturers
Site Name:
AABBCC
Company Name:
XXYYZZ
1. Context of Observation:
During the WHO-GMP inspection conducted on 24/04/2026, inspectors reviewed the pharmaceutical quality system documentation governing outsourced manufacturing activities. Although the company had established a documented Quality Manual describing its overall Quality Management System, it was observed that formal Quality Agreements with contract manufacturers were either absent, incomplete, or not approved and executed.
The absence of documented Quality Agreements creates ambiguity regarding responsibilities for GMP compliance, quality control, change management, deviation handling, complaint investigation, product release responsibilities, audit rights, regulatory communication, data integrity, documentation retention, and recall management between XXYYZZ and its contract manufacturing partners.
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-quality-agreements-missing-with-contract-manufacturers/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-quality-agreements-missing-with-contract-manufacturers/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-quality-agreements-missing-with-contract-manufacturers/
