Vendor Qualification
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Dharmesh PatelVendor Qualification
Uploaded by
Dharmesh PatelVendor Qualification:
The primary step for Manufacturing is to ensure that API (DS) Vendor Qualification is compiled to
manufacture a FDF- Finished Dosage Form / Formulation (Drug Product) which confirms the
Product Quality.
The same funda is applicable to API for which KSM is sourced for API manufacturing.
Every company will have a different approach for Vendor Qualification / Supplier Approval
Process and the requirements may vary slightly.
But the Universal Approach / Global Outlook for VQ would be almost similar.
For the Benefit of the People who like to know and who wanted to have more about Vendor
Qualification/ Supplier Approval Process, herewith I am giving a Brief knowledge update:
For Example, to qualify a API ( Drug substance),
For Qualifying a Vendor ( Manufacturer) to procure the material , the mere requirements are as
follows:
I. Pre-shipment Sample Evaluation:
3 Consecutive / Continuous Samples submission for testing.
Three samples would be more appropriate.
Some vendors may give only 2 Samples due to the Cost of Material or for any other reason, but it
is to confirm and to ensure that the batches are passing and Manufacturer material is meeting
the requirements to qualify the Vendor.
The need is to look to that extent only. Other criteria are given below:
II. As a part of the vendor qualification procedure, the below list of documents to be provided but
not limited to:
1. Vendor Assessment Questionnaire
2. Route of Synthesis
3. Product List
4. Specification and Method of Analysis (STP)
5. Elemental Impurities Declaration / Statement / Risk assessment report
6. MSDS (Material Safety Data Sheet)
7. Residual Solvent Declaration
8. Organic Volatile Impurities
9. Allergen Declarations/ Genetically Modified Organism (GMO) declaration
10. ISO Certificate / any other GMP / Regulatory Approval Certificate (Ex. GMP Certification
MHRA, WHO, EDQM, TFDA, TGA etc.).
11. Packaging material info (Declaration of Standard Pack type)
12. Mfg. Process Flow
13.Nitrosamines impurity declaration / Nitrosamines. Risk Assessment
14. TSE / BSE Declaration
III. Onsite Audit / Physical Audit
In Case, Onsite Audit is not feasible or Viable, then Risk based audit / Remote Audit / Virtual
Audit shall be performed.
IV. Quality Agreement (As per APIC Template)
If all the above parameters are complying, then the Vendor is Qualified & Approved.
As per the Business Exigency or Material Urgency, Procurement / Purchase Team and QA / CQA
teams shall work together to qualify the vendor at a faster pace subjected to ensuring the
Compliance to meet Basic cGMP & Regulatory Requirements.
Other verifications shall be done on different criteria:
A. New Material but Existing Vendor
B. New Vendor and New Material
etc.
Again it is based on the Company's Policy or QA/ CQA Procedures and Business call with Quality
Consciousness’, decision shall be taken.
Hope it is beneficial.
