CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
PRESENT / EXISTING PROCEDURE(S)
Currently, procurement of API is performed from approved vendors listed in the Approved Vendor List (AVL).
The existing vendor qualification process includes:
- Vendor Questionnaire Evaluation
- Quality Risk Assessment
- GMP Documentation Review
- Trial Material Evaluation
- Analytical Evaluation
- Commercial Evaluation
- Vendor Approval by QA
Current observations indicate:
- Dependence on limited approved vendors.
- Potential supply chain interruptions.
- Increased procurement lead time.
- Business continuity risk.
- Capacity constraints at existing suppliers.
- Market demand increase.
- Need for alternate qualified sources.
Although existing vendors are performing satisfactorily, addition of an alternate qualified API vendor is required to ensure uninterrupted material availability and business continuity.
DESCRIPTION OF CHANGE (PROPOSED CHANGE)
A new API vendor shall be added to the Approved Vendor List (AVL) after successful completion of vendor qualification activities.
The proposed change shall include:
- Vendor qualification.
- Vendor questionnaire review.
- GMP assessment.
- Vendor audit (if applicable).
- Technical document review.
- Trial material procurement.
- Analytical testing.
- Comparative evaluation.
- Regulatory assessment.
- Stability assessment (if required).
11. Risk assessment
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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https://pharmaguidehub.com/product/change-control-report-for-the-addition-of-new-api-vendor/
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
Find below the pages for the complete report:
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/change-control-report-for-the-addition-of-new-api-vendor/
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
Find below the pages for the complete report:
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
Find below the pages for the complete report:
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
Find below the pages for the complete report:
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR
Find below the pages for the complete report:
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/change-control-report-for-the-addition-of-new-api-vendor/
