1. Certification Standards:
· Pharmaceutical manufacturer -certificate of Good Manufacturing Practice (GMP)
· Audited by HPRA (Health Products and Regulatory Authority of Ireland) to EU directive.
· ISO 9001:2015
· ISO 13485: 2016
· ISO 14001: 2015
· OHSAS 18001:2007
2. Raw material and packaging suppliers audited to GMP and /or ISO9001:2015 standard by
Medentech personnel.
3. Medentech operates a fully audited batch tracking system and retains samples of all batches for shelf-life plus one year.
4. Validated manufacturing processes.
5. Complete quality control analysis for all batches according to customer specifications
6. Stability studies conducted according to ICH (International Committee on Harmonisation)
7. Has a team of highly qualified technical personnel to PhD standard.
8. NSF Approved for 10mg per litre. (Not all products NSF approved)