During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that the ROLES AND RESPONSIBILITIES OF QA AND QC ARE NOT CLEARLY DEFINED. This has been received.
The compliance report along with supporting documents is to be submitted within 30 days.
Context of Observation:
During the WHO-GMP inspection, it was observed that although an SOP titled “Responsibility of Quality Unit” is available at the site, the roles and responsibilities of Quality Assurance (QA) and Quality Control (QC) personnel were not clearly defined, segregated, and effectively implemented in practice.
The inspectors noted:
- Overlap of responsibilities between QA and QC functions.
- Lack of clarity among personnel regarding decision-making authority (e.g., batch release, deviation approval).
- Absence of role-specific accountability in quality-related activities.
This indicates that while documentation exists, practical implementation and clarity of responsibilities are inadequate, which may impact the independence and effectiveness of the Quality Unit.
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/compliance-report-for-roles-and-responsibilities-of-qa-and-qc-are-not-clearly-defined/
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/compliance-report-for-roles-and-responsibilities-of-qa-and-qc-are-not-clearly-defined/
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/compliance-report-for-roles-and-responsibilities-of-qa-and-qc-are-not-clearly-defined/
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/compliance-report-for-roles-and-responsibilities-of-qa-and-qc-are-not-clearly-defined/
