Quality Assurance

1. (a) Pharmaceutical manufacturer -certificate of Good Manufacturing Practice (GMP)
   (b) Audited by the Irish Medicines Board (IMB) to EU directives
2. (a) ISO 9001:2008
   (b) Plant-wide audit by SGS
3. All raw material and packaging suppliers audited to GMP standard by Medentech personnel
4. Medentech operates a fully audited batch tracking system and retains samples of all batches for shelf-life plus one year.
   1. Manufacturing processes are audited to comply with EU protocols (Annex 15 of EU guide to GMP)
   2. Manufacturing processes validated to ensure consistent active ingredient content in each tablet - uniformity of content.
5. Active ingredient (NaDCC):
   1. US EPA (US Environmental Protection Agency)approved for long term drinking water treatment. 
   2. Certified by NSF International (National Sanitation Foundation) - Collaborating centre designated by WHO (ANSI 60)
   3. NaDCC - Manufactured in compliance with published specifications and approved sources.
   4. Notified under European biocidal products directive (BPD).
6. Aquatabs are NSF certified
7. Effervescent base -- Pharmaceutical/Food grade materials
8. Aquatabs stability / shelf-life:
   1. Defined shelf-life for all tablet sizes/presentations, stability / shelf-life established through studies carried out in accordance with ICH (International Committee on Harmonisation) Standards.
   2. Aquatabs have been verified to remain stable on storage in a range of climate conditions for 5 years (foil strips) or 3 years (tubs)

Validation

1. Specifications set for all finished products:
2. Assay (NaDCC/chlorine content)
3. Uniformity of content
4. Dissolution
5. Tablet hardness/friability
6. Weight uniformity
7. Appearance
8. Identity
9. Specifications are set In accordance with published standards (e.g. Eur.Pharm)

Documented procedures are in place to ensure materials and products conform to specifications:
(a) Internal GMP audits
(b) External audits (SGS, ISO 9001:2008, IMB, GMP, ISO9002000)

Quality Policy and Statement