GMP compliance is challenging – whether you’re just starting up, are looking to expand on the range of services or products you provide, or have come out of a tricky audit, our experienced professional GMP experts have years of practical experience to share with you. Some of the questions you might find yourself asking are:

  • Which regulations do we have to comply with?
  • What’s the interpretation of a particular aspect of a GMP code?
  • What classification category do 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?

 

What Our GMP Consultants Can Offer:

  • GMP compliance advice that is based on cost-effective and practical compliance – not just compliance without regard to business demands!
  • We can establish a robust, cost effective quality management system (QMS) that will support your GMP compliance objectives. We can supply professional technical writers as well as document templates all aimed at delivering and effective and compliant QMS for your site
  • We can assess your current equipment and facility status and set up a comprehensive validation program to suit.
  • We can combine continuous improvement methodologies like Six Sigma, Lean manufacturing, 5S and other world class manufacturing techniques with GMP compliance.
  • We can troubleshoot and solve specific GMP compliance issues – this could include conducting a mock audit or reviewing the findings from a regulatory audit you’ve just had in order to determine the best course of action.

 

More Information

If you are worried about compliance or just want to ask a few questions, contact us to find out more about us and what we can do for you.

If you want to read more about regulatory matters and topics relating to PIC/S, the ICHFDA, TGA, MHRA or EU and EMA, click on the relevant links.