Product Quality Complaints

Established Processes to Collect, Track, and Document Product Quality Complaints

Despite the fact that pharmaceutical products are manufactured in compliance with good manufacturing practices, patients and healthcare professionals may still experience the need to report a perceived product quality issue. When the time comes, do you have the procedures in place to capture all details of those complaints to support your product quality investigations? ProPharma Group’s highly trained staff follow established processes to collect, track, and document complaint information.

ProPharma Group’s product quality complaint handling support includes the capture of such critical information as:
  • Complainant contact information and date received
  • Type of complainant
  • Product name, strength, form, dose, lot number, and expiration date
  • Specific complaint details
  • Supporting information such as pharmacy, wholesaler, reporting agency, and reporter’s restitution preference
  • Cross-referencing to associated adverse event or medical information inquiry

When you partner with ProPharma Group, we provide:
  • Product complaint case records sent electronically to your QA department for their quality investigation
  • Facilitation of product return/retrieval
  • Follow-up with complainant to collect additional information
  • Results letter to complainants following investigation
  • Attachment of documents to the product complaint record allowing ProPharma Group to be the central repository for product quality complaints
  • Monthly reconciliation and a detailed monthly summary report