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Quality assurance system

COMPLIANCE STATUS

Our quality systems are fully compliant with ICH guidelines (GMP guideline for APIs), and all of three production sites have been successfully inspected by the US FDA and AIFA (Italian Medicines Agency). Our successful inspection track record, established over more than 45 years, is evidence of our commitment and ability to maintain quality systems that satisfy the rigorous standards set by regulatory agencies.

In addition, our customers, including the top pharmaceutical companies, regularly visit our facilities in order to verify the GMP compliance. In 2016, our production sites underwent an average of more than two audits per month. This intensive audit program provides us with exposure to the latest industry trends, which we view as very good drivers for constant improvement in our quality system.


Quality Department

An experienced and qualified Quality Unit team is present in each of our sites to maintain local compliance with cGMP and regulations. Furthermore, the corporate quality assurance team ensures consistency, sharing of best practices, and continuous quality system improvement in all of sites.


Quality Control


Well equipped, state-of-the-art laboratories perform fully tests according to the Pharmacopoeia (e.g.: EP, USP, JP), in-house developed analytical methods, and customers requirements.
Our staff of chemists has an extensive knowledge and expertise in validating analytical methods for raw materials, API’s and cleaning procedures in compliance with the current ICH and FDA guidelines.
ICH stability studies, stress tests, and forced degradation studies are also performed to guarantee the long-term quality of our products.

Furthermore, the Corporate Quality Control team ensures DL response in term of development of analytical method, validation of analytical method and support on site to all QC activities 


Dipharma quality control equipment are
•  34 HPLCs
•  15 GC units with headspace unit for residual solvents
•  2 UV Spectrophotomer
•  3 FT-IR spectrophotometer
•  2 Alpine Jet Sieve for particle size determination
•  1 Fritsch Analysette laser light scattering granulometer
•  3 Laser Granulometer Malvern
•  4 Polarimeter
•  4 Melting Point Apparatus
•  4  Microscope
•  5 Potentiometric titrator
•  6 Karl-Fischer titrator
•  2 Jet sieve apparatus
•  2 Digital Photo Documentation System
•  6 Stability Test Chambers
•  Lab equipment (pH-meter, Conductimeter, heating plates, …)


Quality Measurements


In order to support our constant improvement process, our quality performance is internally monitored with a set of broadly based measures. These measures are collected and reviewed by the quality teams at each site and monitored by corporate management to identify and understand any trends, potential issues and most importantly, to ensure that any necessary preventive actions are taken to guarantee the quality, continuous improvement, and the success of our business.