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Questionnaries VENDOR QUALIFICATION

The document contains 5 questions related to vendor and supplier qualification for a pharmaceutical company. It asks who is responsible for identifying and assessing vendors, the frequency of re-qualification for secondary packaging (every 2 years) and raw materials (every 3 years), and whether a trial report and quality control test report are required for approving new raw materials. It also asks if a vendor can be approved based on a certificate of analysis and test report from an external lab.

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Dharmesh Patel
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72 views1 page

Questionnaries VENDOR QUALIFICATION

The document contains 5 questions related to vendor and supplier qualification for a pharmaceutical company. It asks who is responsible for identifying and assessing vendors, the frequency of re-qualification for secondary packaging (every 2 years) and raw materials (every 3 years), and whether a trial report and quality control test report are required for approving new raw materials. It also asks if a vendor can be approved based on a certificate of analysis and test report from an external lab.

Uploaded by

Dharmesh Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Questio Question Marks

n No. obtaine
d
1. Who is responsible to identify the vendor / supplier and to arrange
vendor assessment from the respective vendor?

2. Vendor may be qualified as an approved supplier based on the COA


of pre-supplied sample and test report of RHIL Quality Control /
External analytical testing laboratory.

True / false

3. Re – Qualification of Secondary printed packing material shall be


conducted every 2 years

True / false

4. Re – Qualification of Raw materials (API and Excipients) shall be


conducted every 3 years

5. In case of New Raw Materials, approval shall be done based on


Trial/Pilot scale Report and test report from QC.

True / false

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