Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP)

The challenge

Global changes and increasing competitive pressure mean that the GMP and quality assurance structure constantly have to be adapted to current needs.

Are you facing the challenge of new regulatory requirements, the expansion of your production or, as a supplier, do you need to satisfy your customers’ GMP requirement?

The solution

Many years’ project experience in GMP consultancy to pharmaceutical manufacturers and suppliers has made us experts in translating GMP requirements into technical requirements. We will identify your improvement potential together with you, devise solutions and manage the implementation of processes.

Your benefits:

  • Inspection security
  • Due diligence & supplier audits
  • Reduce the operational risk from “non compliance”

Whether it is qualifying suppliers, machines, equipment or entire infrastructures, we will support you at every stage of the project.

As part of strategic consultancy we will work out with you how the GMP requirements can be implemented sensibly and efficiently, making it possible for you to actually save resources. We will carry out the project management for new building and conversion projects with you and will take care of the entire scope of GMP qualification and validation. In the operational implementation we will support you to produce test plans and documentation, carry out tests and everything that is necessary.

We will lend you our support with our pharmaceutical expertise, even when it comes to Due Diligence and Supplier Audits. Experienced auditors and an approved audit scheme enable us to carry out GMP audits flexibly and discreetly.