“Quality is everyone’s responsibility
and we never have to stop getting better”

– W. Edwards Deming –

QUALITY ASSURANCE

highest quality with accurate and timely results

Our Quality Assurance department is responsible for offering our clients with services of highest quality with accurate and timely results. The Quality Assurance Department monitors the day to day operations, from the R&D department to the Quality oriented management decisions.

Our laboratories operate under strict quality procedures which meet both GMP and ISO 17025 requirements. The studies are performed by a team of experienced and highly qualified scientists (chemists and pharmacists), all experts in pharmaceutical analysis, who are aware of the latest developments through continuous training.

Our technical competence is continuously challenged. The reliability of our laboratory’s data is assessed and demonstrated by our regular participation in international Proficiency Testing Schemes (PTS) organized by EDQM.

GMP

that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” (EMA)

 

A GMP system ensures that every product is produced and controlled according to specific quality standards. The implementation of a GMP system aims to minimize in every aspect of any pharmaceutical production those risks that cannot be eliminated through testing the final product.

To achieve this, every single process must be described in detail in written procedures. The implementation of these procedures also provides documented proof that the correct procedures are followed at all times.

The principles and guidelines for GMP in the European Union are stated in two Directives for medicines for human use and for veterinary use, 2003/94/EC and 91/412/EEC, respectively. The GMP Guidelines provide interpretation of these principles and are supplemented by a series of annexes that may modify or augment the requirements for certain types of product, or provide more specific guidance on a particular topic. Compliance with these principles and guidelines is mandatory within the EEA and the national authorities of each country are responsible for their enforcement.

More information on GMP :

ema europa
european commission
eof Greece

ISO 17025

ISO 17025 is the most important international standard for testing and calibration laboratories.

ISO 17025 applies to all laboratories carrying out tests and/or calibrations, including sampling. These tests may be performed using standard, non-standard or in-house (developed by the laboratory) methods. It specifies the general requirements for the competence of a laboratory to perform the aforementioned tasks/activities.

The accreditation is granted by an accreditation body, in Greece the “Hellenic Accreditation System, E.SY.D.” and only after thorough evaluation of the laboratory’s Quality Management System as well as actual demonstration of the laboratory’s technical competence (premises, instrumentation inspection etc.) When the accreditation is granted, the Scope of Accreditation is also issued. This document is the official listing of all the activities (specific tests, types of tests, technologies, etc.) for which the laboratory has been deemed competent to perform. For chemical testing laboratories, where flexibility is required (regarding the variety of samples, testing methods applied, etc.), it is usually desirable the issuance of “Flexible Scope”. A flexible scope can only be awarded when the laboratory demonstrates a design/development process of expanding into additional areas not previously undertaken. QuamliMetriX is ISO/IEC accreditated, while “Flexible Scope“ has been granted.

Αfter the initial accreditation, the accredited laboratories, are regularly audited by the responsible Accreditation Body, in order to ensure their continued competence and compliance with the standard.

More information on ISO 17025 :

iso.org
esyd.gr

PTS - EDQM

“a form of external assessment of quality control management systems using inter-laboratory comparisons to determine the performance of individual laboratories in carrying out specific tests or measurements” (EDQM)

EDQM PTS (Proficiency Testing Scheme ) studies include basic analytical methods (physicοchemical and biological) and the laboratories participation provides an objective means of demonstrating the data reliability for these methods against the members of the General European OMCL Network (Official Medicines Control Laboratories) as well as other medicines control laboratories.

EDQM organizes about 5 PTS studies on annual basis in the physicοchemical area and 4 in the biological area. The studies planned for each year are posted on the EDQM website.

More information on PTS EDQM :

edqm.eu