Production master document

Bioneer's deliverables include a practiced Production Master document containing and compiling the procedures and protocols developed for scale up of the process. The Production Master provides a roadmap to the management for on-time start-up of facility operations and enables clients to plan and evaluate their production process.

Bioneer secures that:

• Scale up of fermentations is performed in a specified production area using production equipment which is fully qualified in compliance with GMP requirements.
• Well-documented cleaning and testing procedures are in place.