Points to be Considered for Pharmaceutical Supplier Validation


Supplier validation or verification, also known as vendor validation, is the process of confirming that a supplier/vendor of your company agree to contract with continuous quality supply maintaining GMP and GDP.



Global sourcing and supply of Active Pharmaceutical Ingredients (APIs) and finished medicinal products, from source to end customer, MUST have robust systems in place for physical and electronic traceability of product.


Validation is KEY to ensuring this and will impact on the below points -

  • Logistics
  • Quality
  • People
  • Management
  • Security
  • Resources
  • Data


Enterprise Resource Planning (ERP) systems are critical electronic systems which MUST be validated where they handle medicinal product related information, such as BOMs, SKUs, inventory levels, inventory status, lot traceability, access rights, storage conditions, supplier & customer details to name a few.


Remember, an ERP system can be used at a manufacturing facility, a stand alone warehouse or at an office of the Marketing Authorisation Holder, where medicines are purchased and sold.


As per FDA Guideline,

Supplier qualification is part of FDA 21 CFR 211 (validation process). Where discuss about the process of supplier's procedures for development, support, maintenance and distribution comply with quality regulations and GMPs.


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Resource Person: Sanjay N.

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