Quality Management

Our Quality System is based on the cGMPs and adheres to the relevant quality guidelines as ICH & ISPE and allows us to meet high compliance standards while implementing continuous improvement processes.

Quality Management System

The Quality Management System has been designed and implemented to fulfil the following basic objectives:

  • Ensuring market supply with a product that possesses quality characteristics that are requested by patients, regulatory authorities, and customers
  • Establishing and maintaining a state of continual control through systems for monitoring processes and quality of our products, thus guaranteeing continuous adaptations to new standards
  • Facilitating continuous improvement and supporting the use of tools to measure risk based on knowledge and scientific criteria

Our Quality Policy

The main commitment of our policy is to achieve and maintain the trust and satisfaction of our customers through the supply of best quality products.

Our facilities are regularly inspected by Health Authorities (European Authorities, FDA, PMDA…) and customers. We have more than 20 years experience with a very good inspections results.

FDA (US) Inspections: 6 FDA Inspections from 1999 to 2017, the last 4 without 483 observations.

PMDA (Japan): 9 Off site inspections.

AEMPS / Generalitat de Catalunya (Spain):  3 inspections, last one in May 2018. No major observation. GMP Certificate valid until February 2024.

Our analytical departments support the whole product lifecycle. Our capabilities are the following:

  • Development of new analytical methods
  • Optimization of existing analytical methods
  • Verification, validation and transfer of analytical methods
  • Analysis and release of raw materials, intermediates and APIs
  • Support the cleaning validation activities
  • Stability studies to define retest/expiry period of the intermediates and APIs
  • Characterization of standards and impurities
  • Elemental impurities evaluation

Our laboratories are equipped with the following main instrumentation:

  • HPLC
  • UPLC
  • GC-HS
  • GC-MS
  • RMN
  • DSC
  • Analytical Techniques for particle size measurements

Our Regulatory Affairs team has an important role in any project during all the lifecycle, in order to prepare and deliver the necessary registration documentation for the intermediates and APIs for submission to the regulatory authorities (US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA)…)

We prepare and deliver the necessary registered documentation for active pharmaceuticals ingredients (APIs) and intermediates for submission according to the guidelines:

  • Drug Master Files for the EU, USA, Japan, China as well as other worldwide markets
  • Complete CMC documentation (Module 3.2.S) for approval applications
  • EP-Certificates of Suitability (CEP)
  • Notifications of change
  • Assessment reports according to ICH Guidelines (genotoxic and mutagenic assessment, elemental impurities, residual solvents…)