1. What is Sanal?
Sanal® is our brand for pharmaceutical salt – www.sanalsalt.com
2. What is Salt?
Sodium Chloride
3. How does pharmaceutical salt differ from our ordinary salt?
The salt is basically coming from the same source as the salt for food and for retail. The difference is that the pharmaceutical salt
- Has stricter QA procedures according to GMP guideline-ICH Q7 rulesb.
- Has a dedicated production linec.
- Complies with the monographs of the national pharmacopoeias Ph. Eur. (Europe), USP (USA), JP (Japan), KP (Korea)
- Is without anticaking agent = additive free salt
4. What is a Pharmacopoeia?
• It is a book containing directories for the identification of compound medicines
• It is published by the authority of a government or a body empowered by a government
• It contains a large number of monographs
5. What is a Monograph?
Monographs are references for pharmaceutical drug specifications
6. What does GMP mean?
Good Manufacturing Practice
7. What is GMP-ICH Q7?
GMP: Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q7: Is the latest version of the ICH quality guidelines relevant for pharmaceutical grade salt
8. What is manufacturing?
All operations of: Receipt of materials, production, packaging, labelling, quality control, release, storage and distribution of API9. Who is responsible for this guide?ICH-Q7 is a committee of USA, Japan and Europe who prepared the first GMP guide
10. What is API?
Active Pharmaceutical Ingredients – (Can also be named as “Active substance” ) Term used for medicines/drugs for direct infusion into the human body. Typical examples are drop bags, providing liquid intravenously, and PD (Peritoneal Dialysis). Eye drops and inhalation sprays also require API.
11. What is HD grade?
HD is a grade that in many ways meets the same criteria as API, but for some reason cannot be labelled API. In popular terms, HD grade is pharmaceutical quality salt, pure salt without additives, that is pure enough to be used for HD but not for direct injection into the bloodstream.
12. What is USP grade?
USP grade means a grade that meets the US pharmacopoeia in terms of chemical composition, but cannot be regarded as an API – because it cannot be approved to the same standards as an API as it also has to be manufactured under GMP. USP grade is the same as HD grade as described in point 11 and 13.
13. What is haemodialysis (HD)?
Haemodialysis is the most common type of dialysis that requires a patient to be connected to a machine for the duration of a treatment. The machine acts as a filter, where the impurities of the bloodstream are filtered out and enables the patient to sustain an almost normal life. Haemodialysis does not require API because there is an active filter protecting the bloodstream from the contents of the dialysis compounds. The working of an HD machine is similar to the concept of reverse osmosis – using concentration gradients to allow the unwanted particles to leave the bloodstream.
14. What is peritoneal dialysis (PD)?
Unlike haemodialysis, PD uses the peritoneal cavity of the human body as a filter. Where there is an artificial system in the HD machine, the system in PD is the human body itself and thus API is required for this type of dialysis.
15. Are all our Sanal products API?
Yes!
