Medentech:

1. Medentech manufactures NSF certified tablets using exclusively NSF  and US EPA registered active ingredient.
2. Is a pharmaceutical manufacturer using Good Manufacturing Practice (GMP)
3. Audited by the Irish Medicines Board (IMB) to EU directives.
4. ISO 9001:2008.
5. Audited Plant-wide by SGS.
6. Audits all raw materials and packaging suppliers to GMP standard by Medentech personnel.
7. Has a team of highly qualified technical personnel to PhD standard.

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.

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)

Quality Policy and Statement