Validant Case Study

Rapid Warning Letter Closure

Challenge

When a European cosmetics manufacturer received a Warning Letter on its sunscreen drug product, which represented less than 2% of factory throughput, the company knew installing GMP would not be economical solution. Therefore, outsourcing was needed and they turned to Validant for support.

Solution

Validant deployed a team with local language skills to:

  • Perform a holistic Quality System assessment, including for Investigations, OOS, and Complaints
  • Lead drug product outsourcing
  • Institute an Interim Control Plan for batches produced until transfer
  • Build a Quality System consistent with the new outsourcing model
Outcome

With Validant’s hands-on guidance and boots-on-the-ground execution, the European OTC manufacturer:

  • Avoided large site-wide remediation saving over $5M in costs.
  • Quickly determined CMO/CLO while minimizing client resources.
  • Demonstrated operational control in the interim resulting in Warning Letter closure.

Ready to get started? Experience the Validant Difference Firsthand.

Let’s discuss your needs today.