Quality

Quality underpins everything we do at Ensign.  It is our focus on quality that enables us to ensure your brand is protected.

Ensign is audited to the PIC/S code by both the Australian TGA (Licence no. 189) and by our exacting multi-national customer base.  We maintain an APVMA license (Licence no. 2040) and accreditation to ISO 9001:2008, ISO 22716 and FSCC 2200. Ensign also has CE Certification and conforms to ISO 13485 for the manufacture of medical devices. All systems and procedures that may impact on product quality are fully validated.

Materials used in manufacture are sourced from approved suppliers and tested before release by our chemical or packaging QC group using the latest equipment.  Ensign ensures all finished product meets specification through in-process checks, including check-weighers and vision systems, validated analytical methods and comprehensive in-house microbiological testing.

Our QA group are responsible for Ensign’s change control process, CAPA system and deviation management. Post-production activities, including real time stability testing, market surveillance and annual product reviews, are also undertaken.