Quality means doing it right when no one is looking (Henry Ford)
Doing quality means to rely on a ROBUST AND INTEGRATED quality system supported by a sufficient numbers of QUALIFIED collaborators.
E-Pharma Quality Unit is supported by 45 collaborators: 35 in Quality Control, 9 in Quality Assurance and 1 manager.
Laboratory equipment is consistenly QUALIFIED AND CONTROLLED and relies on
- 10 Instruments for High Performance Liquid Chromatography (HPLC)
- 1 Instrument for Ultra Performance Liquid Chromatography (UPLC)
- 1 Instrument for Gas Chromatography
- 1 Instrument for Dissolution test (with off-line and on-line sample collection system)
- 1 Instrument for Disgregation test
- 1 Instrument for Inductively coupled plasma atomic emission spectrometry
- 1 TOC (Total Organic Carbon) analyzer
- 1 IR (Infrared) spectrophotometer
- 1 NIR (Near - Infrared) spectrophotometer
- 1 UV (Ultra Violet) spectrophotometer
- 4 Thermobalances
- 3 Rotronic Relative Humidity analyzers
- 1 Instrument for water content analyzer (Karl Fisher)
- 2 Instruments for determination of hardness, diameter and thickness
- vacuums for the leak test
- 1 Instrument for the friability test
- 1 Malvern particle size analyzer
- 2 Sieves for particle size analysis
- 1 automatic titrator
- 1 oven for loss on drying determination (test at reduced pressure possible)
- 1 muffle furnace
- analytical balances
- pH- meters
- conductivity meters
- climatic chambers for stability studies with automated continuos monitoring
- dishes incubators for microbiological analysis
- validated LIMS IT system integrated with the ERP to accept incoming samples, register analyses, manage stability studies, release raw materials and finished products, manage QC sampling files
- validated ADIUTO IT system for the management of quality documentation, in full compliance with the provisions of the GMP regulations
E-Pharma, according to the current guidelines (ICH Q10) endorses the CONTROL AND 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.
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.
To grant CROSS CONTAMINATION RISK PREVENTION, in collaboration with renowned toxicological experts, we have in place, starting from beginning 2015, the related prevention program according to the guidelines (Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities ). We therefore offer to our customers products fully in compliance with this guideline.
As well, we offer to our customers our EXPERTISE in the redaction of the Risk Assesment related to the Elementary Impurities, as ruled by the current guidelines (ICHQ3D), and to the Nitrosamine risk evaluation.
We are well in compliance with the most recent European guideline related to the SERIALIZATION AND MEDICINE ANTI-TAMPERING (EU-Directive “Falsified Medicines Directive 2011/62/EU). We have also integrated an MULTI-LEVEL AGGREGATION system for the packing, according to the Russian guideline.
Quality AUDIT 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.
During 2023 we successfully completed:
- the audit of the Italian pharmaceutical authority AIFA;
- an audit of foreign pharmaceutical authorities;
- numerous audits by customers;
- the renewal audit of the ISO FSSC22000 certification (Food Safety System Certification) which demonstrates compliance with the requirements set by the standard in terms of food safety for the headquarters located in via Provina 2;
- the ISO FSSC22000 certification audit (Food Safety System Certification) which demonstrates compliance with the requirements of the standard in terms of food safety for the new food supplement production site located in via Provina 1a;
- the Halal certification renewal audit which demonstrates compliance with the requirements established by Islamic law for the headquarters located in via Provina 2;
- the Halal certification audit which demonstrates compliance with the requirements established by Islamic law for the new food supplement production site located in via Provina 1a.
E-Pharma systematically evaluates the quality system and the compliance level of the suppliers of raw materials and services as well.
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).
The manufacturing process of our food supplements (in process controls, control and release of the finished product, stability and related documentation) is GMP alike and is in compliance with ISO FSSC22000.
For these reasons, our food supplements are safe for the consumer.