NHP Regulatory Consulting – Supplier Qualification

See also Acquisition Due Diligence

Supplier Qualification

Ingredient Supplier Qualification is a poorly understood concept, yet a critical component in ensuring the quality of finished products that go to market. Natural health products manufacturers should qualify their raw material suppliers so that there is a high level of confidence in the Certificate’s of Analysis (C of A’s) provided by the Supplier. Proper ingredient supplier qualification is essential for avoiding supply chain problems and maintaining product traceability. As raw material Supplier’s are not covered by the GMPs, the onus is on the manufacturer to ensure that the Suppliers they do business with are qualified – this can be an arduous, complicated and expensive task.

Our services in Supplier Qualification include:

  • 3rd Party Audits of raw material Suppliers
  • Developing Audit plans and checklists to assess raw material Suppliers
  • Development of Supplier qualification Standard Operating Procedures (SOPs)
  • Development of SOPs for raw material lots that fail testing
  • Requalification of existing Suppliers
  • Classification of Suppliers by risk (e.g. high risk vs. low risk Suppliers)
  • Certificate of Analysis (COA) content and format recommendations and verification
  • Review of Supplier quality systems and testing methods for GMP compliance
  • Creation of GMP contracts

At dicentra we have a team of experts qualified to assess your Suppliers and ensure they meet GMP requirements, offering you peace of mind so that you can focus on your day to day business activities.