GMP Compliance Strategy

GMP compliance can be complex, some of the questions we get asked include:

  • Which regulations do we have to comply with?
  • What’s the interpretation of a particular aspect of a GMP code?
  • What classification category does our product(s) fall into?
  • Where does GMP start in an API facility?
  • When should GMP start during an engineering project?
  • What should be validated in our facility?
  • We are building a new plant and one of the codes of GMP we comply with is changing – what should we do to make sure we still comply?

Our GMP consultants can help you with:

  • General GMP compliance advice that is based on cost-effective and practical compliance, not just compliance without regard to business demands.
  • Establishing a robust, cost effective quality management system that will support your GMP compliance objectives.
  • Troubleshooting and solving specific GMP compliance issues. This may include conducting a mock audit or reviewing the findings from a regulatory audit to determine the best course of action.

Regardless if your company is just starting off or well established, our experienced professional GMP experts have years of practice experience to share with you.