Quality

Quality is one of our core values, and as such, we invest a significant amount of attention and resources into ensuring that we support our continuous improvement process and culture in this area.

Every day we work to:

  • provide high quality products and professional services to the global pharmaceutical industry through our skilled personnel and systems
  • surpass regulatory requirements and the expectations of our customers

Quality assurance system
Compliance status

Our quality systems are fully compliant with Good Manufacturing Guidelines for API (ICH Q7 and Eudralex GMP Part II), and all our Italian production sites have been successfully inspected by the US FDA and AIFA (Italian Medicines Agency).

Our successful inspection track record, established over 50 years, bears witness to our commitment and ability to maintain quality systems that meet the rigorous standards set by regulatory agencies.

In addition, our customers, which include top pharmaceutical companies, regularly visit our facilities to verify our GMP compliance.

This intensive audit program provides us with exposure to the latest industry trends, which we view as excellent drivers for constant improvement in our quality system.

An experienced and qualified quality unit team is present at each of our sites to maintain local compliance with cGMP and regulations. Each quality unit is led by the site quality assurance. Furthermore, the corporate quality assurance team ensures consistency, sharing of best practices and continuous quality system improvement at all of our sites.

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 success of our business.

Well-equipped, state-of-the-art laboratories perform complete tests according to the Pharmacopoeia (e.g. EP, USP, JP),
in-house developed analytical methods and customer requirements.
Our staff of chemists have extensive knowledge and expertise in validating analytical methods for raw materials,
intermediates, 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 terms of development and validation  of the analytical method and on-site support for all QC activities.

  • HPLC unit with UV detector
  • HPLC unit with RI detector
  • HPLC unit with Corona CAD detector
  • HPLC with mass detector
  • Ion chromatography
  • GC unit with direct injection
  • GC unit with headspace unit for residual solvents
  • UV Spectrophotometer
  • FT-IR spectrophotometer
  • X-Ray diffractometer
  • ICP Inductively coupled plasma – OES
  • Air-Jet Sieve for particle size determination
  • Vibrating sieves
  • Malvern laser granulometer
  • Polarimeter
  • Melting Point Apparatus
  • Microscope
  • Potentiometric titrator
  • Karl-Fischer (volumetric and coulometric) titrator
  • Digital Photo Documentation System
  • Stability Test Chambers
  • Lab equipment (pH-meter, conductometer, heating plates, …)

Regulatory affairs
department

Addressing regulatory matters in a timely and accurate manner
is an important factor for the success of our customers.

This is achieved through:

A thorough understanding of the expectations, requirements and regulatory filing procedures of registration dossiers in the EU, USA, China, Japan, Taiwan, Korea, Brazil, India, Russia and Ukraine.

Detailed knowledge of how to manage variations and changes in accordance with local regulations.

Continuously updating our regulatory personnel on the latest practices and policies of the appropriate authorities (MHRA, TGA, FDA, AIFA, EMA, etc.).

Authorities inspections
Fully cGMP compliant Quality System

Baranzate

 Italy

Caronno

 Italy

Mereto

Italy

Kalamazoo

USA

Authorities inspections
Fully cGMP compliant Quality System

Baranzate

 Italy

Caronno

 Italy

Mereto

Italy

Kalamazoo

USA