cGMP compliant documentation
Deliverables comprice product and product documentation including a Certificate of Analysis.
Bioneer contract manufacturing is characterized by:
- A production facility approved by the Danish regulatory authorities for fermentation of Bio Hazard Class I and Class II microorganisms.
- A well-defined production area with restricted access to minimize the risk of cross-contamination.
- Production equipment which is fully qualified in compliance with GMP requirements.
- Well-documented cleaning and testing procedures.
- Written procedures for in-process quality control (QC) and QC testing of final product.
Bioneer quality systems