Quality

Quality means doing it right when no one is looking (cit. Henry Ford)

Doing quality means to rely on a robust integrated quality system supported by a sufficient numbers of qualified collaborators.

E-Pharma, according to the current guidelines (ICH Q10) endorses the control and the continuous improvement process; particularly, we carefully and constantly monitor the lifecycle of our processes and products in order to plan actions well in advance rather than to take heavy and expensive corrective actions afterwards.

quality

Quality audits held by Health Authorities and by our customers, together with an efficient internal inspection program, grant a constant increase of the quality level of our services and products.

audit

Our Quality System is built according to the most recent Risk Management approach (ICHQ9) which embraces all our sectors: from the product development to the suppliers management, from the building of a new production area to the cross contamination risk prevention.

RISKmanagement

In collaboration with renowned toxicological experts, we have implemented starting from beginning 2015 the cross contamination risk prevention program according to the related guidelines (Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities ). We can now offer to our customers the toxicological report of the product manufactured at our premises.

We offer as well to our customers our expertise in the redaction of the Risk Assesment related to the Elementary Impurities as ruled by the current guidelines (ICHQ3D).

We are now working hard to be in compliance with the European guideline related to the serialization and medicine anti-tampering (EU-Directive “Falsified Medicines Directive 2011/62/EU) by the deadline of the 9th February 2019.

Our Quality Policy grants that even the food supplements are being manufactured according to procedures that can be assimilated to GMP guidelines (i.e. in process controls, release of the finished product, stability, documentation on support). We do analyze all the raw materials, nutritional ingredients as well as excipients, according to pharmacopoeia (Ph.Eur., USP, BP) and alimentary guidelines (Reg. 231/2012 and updates, FCC).

Certifications

- EU GMP Certificate issued by the Italian Medicines Agency (AIFA)

- Authorization/recognition issued by the Italian Health Authorities to produce pharmaceuticals and food supplements

- E-Pharma Trento SpA inspected by the FDA as manufacturer of food supplements for the US market

- E-Pharma Trento SpA is registered by the TGA for the Australian market

- E-Pharma Trento SpA is registered by the United Arab Emirates for the market of food supplements



Health & safety policy

 

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