Bio Process Validation

Synergy Bioscience has a lot of experience in designing GMP facilities so they will be easy to keep clean, have logical product and personnel flow, and pass regulatory scrutiny.

Synergy Bioscience can support you by

  • Reviewing your current design plans
  • Helping you figure out a scientifically based remodel
  • Helping you investigate problem areas
  • Informing you of the latest industry practices
  • Determining the best room classifications
  • Iintegrating your design so it meets both FDA and EU regulations
  • Getting your facility operating smoothly, with fewer investigations and corrective actions to slow down the day to day operations

Once your facility is up and running, we can also help you validate and monitor its effectiveness, and develop the necessary documentation for the following:

  • Validation Master Plan
  • Protocols and Reports
  • Set environmental monitoring limits
  • Set up an effective, reasonable environmental monitoring program, taking into account FDA, USP, EU, and ISO considerations
  • Set up a reasonable personnel monitoring program
  • Set up a data trending system

To discuss how Synergy Bioscience can help you, please contact us