New Vendor Approval Process in Pharmaceutical Industry


Vendor approval activities are a routine work for a pharmaceutical industry. Where a new vendor is added for a material with predefined specification. During the vendor approval activities a lot of sequential activities are to be performed including material quality, feasibility and regulatory assessment.


Vendor approval activities mainly start from supply chain department. Where supply chain shall consult with formulation development department for sample handover to develop a new source as well as alternative source of a material. After receiving the sample formulation department personnel shall submit the sample to analytical department for initial analysis of raw material.


After analysis of the material a formulator shall execute trial batch and initiate stability study at accelerated condition for 6M. If trial batch / stability study is not mandatory, then FD shall prepare a risk assessment / justification and communicate with QA department to go ahead for the approval of the vendor based on Analytical test report and Formulation trial report (as applicable) through the request form.


Then QA will coordinate with Supply Chain to collect the documents from the vendor as per the predefined checklist. After receiving all required documents QA will approve the vendor in system.


Document/Information require from R&D department as a part of new Vendor approval activities are mentioned below:

  • Vendor assessment report
  • Analytical report
  • Lab trial Report
  • Microbial report (if required)
  • Stability data
  • Comparative study of materials (for alternate source of API/two or more vendor)


Related: API Checklist for Vendor Assessment


Documents/ Information require from a supplier as a part of new Vendor approval activities are mentioned below:

  • cGMP Certificate
  • BSE/TSE Certification
  • Residual Solvent statement
  • Melamine free Certifications statement 
  • Iron content declaration
  • Risk assessment and control strategy/ Statement for elemental impurity 
  • Risk assessment and control strategy/ Statement for Nitrosamine impurity
  • Food grade certificate for packaging materials


Based on above assessment and documents of a material QA or Vendor approval department will decide to approve a vendor or not.


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Tags in: Vendor qualification checklist, Vendor qualification process flow chart, FDA Guideline for vendor qualification, vendor qualification questionnaire.

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