Quality

QUALITY ASSURANCE Our aim is to assure the quality, security and efficacy of the manufactured products.

The quality assurance system is based on :
- a clear organisational structure with defined responsibilities on every level
- qualifications and validations (premises, equipment, personnel, processes, methods, utilities),
- a documentation management system, including data traceability,
- audits (of suppliers, internal audits).

This quality assurance system is regularly audited by our clients and by authorities and thus guarantees the quality of our service in compliance with the pertinent regulations and standards.

QUALITY CONTROL LABORATORY We have our own quality control laboratory specifically equipped for all physico-chemical and microbiological analysis required for sterile and lyophilised products according to the European Pharmacopeia:

- sterility test under isolator,
- test on endotoxins,
- Karl Fischer titration,
- test on visible and sub-visible particles,
- etc.

As well as other analytical techniques such as:
- determination of Total Organic Carbon,
- HPLC,
- UV/VIS spectrophotometry,
- IR spectrometry,
- pH,
- potentiometric titration,
- etc.