Vendor qualification and evaluation in pharmaceutical industry

Abstract

To deliver a high quality and safe medicines, it is a must to certify the vendor according to the GMP requirement. This qualification is done to prevent the adverse events, prevent the recalls or serious illness or death due to the low standard quality of manufactured medicines. Vendor qualification is the process by which a vendor is assessed to determine, if it can provide the required goods or services to the standards that the purchasing company requires. This article explains about the detailed procedure for qualifying raw material ven-dors, packaging vendors and service providers. This also explains the vendor assessment and the reassessment. Vendor re-assessment must be carried out at least once a year for each packaging material and the raw material. The manufactured part number is used for tracking. Supply Chain Management team (SCM) should request the QA department to generate Manufacturing Part Number. Explained about the vendor rating. The vendor must be disqual-ified if the batch will not adhere to specification of critical tests. For further evaluation and investigation, vendor must be once again qualified. Vendor must be informed regarding the removal and the reasons must be explained clearly. Vendor Relationship Management (SRM), is systematic planning and managing of all interactions with suppliers to maximize its value.