Quality Assurance

QUALITY ASSURANCE

Our commitment to our work and to our customers continually drives us to ensure the highest quality levels.

We exceed all of the most demanding standards, providing an excellent service that has been recognized by numerous European certificates.

Our Quality Department

The Alcaliber Quality Department is the key to ensuring compliance with the highest standards of quality, not only in accordance with the latest regulations in force, but with the aim of achieving excellence in the manufacture of all our products.

Each stage of the production chain is studied and analyzed exhaustively, ranging from the receipt of auxiliary materials, validation of analytical methods, validation and analysis of processes, gauging, laboratory tests during processes, etc. The quality control laboratory is equipped with the latest analytical lab equipment, featuring various HPLC, GC, IR, stability cabinets for ICH studies, as well as highly qualified personnel.

Thanks to our commitment, dedication, high personal standards and passion for what we do, we are proud of our results and the recognition we receive from our customers.

We adapt to the different needs of our customers.

The fundamental work of the Quality Department is divided into:

Quality Assurance and Regulatory Affairs

1

Development of dossiers for the Spanish Drug Agency (AEM) and EDQM.

2

Development of ASMF’s and CEP’s. Update of documentation and monitoring of deadlines and records with the EDQM.

3

Implementation of the latest regulations in force.

4

Preparation and monitoring of Alcaliber internal audits.

5

Customer and official authority audits: identification of corrective measures, implementation of measures, change monitoring…

6

Monitoring with customers of required documentation and preparation of quality certificates.

7

Stability studies according to ICH standards, monitoring and reporting.

Quality Assurance Laboratory

Quality Assurance Laboratory

1

Development and review of documentation for compliance with the Pharmacopoeia and the most demanding specifications.

2

PQR (Product Quality Review).

3

Qualification of equipment and instrumentation, and compliance with established production parameters.

4

Equipment Calibrations.

5

Analysis during production at different stages and process validation.

6

Validation of analytical methods.

7

Analysis and validation of processes in development and R&D+Innovation.

8

Impurity profiles / identification / characterization.

This has led the company to been granted ASMF’s and Certificates of Compliance with the European, USP, BP, IP Pharmacopoeia, for the main products derived from poppies and their Active Pharmaceutical Ingredients derivates.

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