Quality Control

Quality Control operates on behalf of National Organization for Medicines (E.O.F.) to third parties and pharmaceutical companies. It has licensed authority by the Institute of Pharmaceutical Research and Technology (I.F.E.T) to perform controls on vaccines and biological products.

Quality Control is certified with GMP (18469/ in conjunction with decision on extension of Controls on Imported Human and Veterinary Medicines) from National Organization for Medicines (E.O.F.) and it is ISO/IEC 17025: 2017 (516) accredited from E.S.Y.D (Hellenic Accreditation System).

It is also member of HellasLab and Eurolab the European Federation of National Associations of Measurement, Testing and Analytical Laboratories.

The scope of Quality Control of the Hellenic Pasteur Institute is to assure that vaccines and other pharmaceutical products conform to specifications in compliance with the current Greek and European pharmaceutical legislation. Quality Control provides reliable laboratory analyses based on principles of good manufacturing practice (GMP), in an independent and impartial way, so as to ensure the high quality, accuracy and reliability of the analytical results with a view to the protection of public health, the excellent service and satisfaction of the requirements of its clients and the overall effective fulfillment of its mission.

Quality Control releases vaccines distributed by the Public Sector. Within the many years of operation, it has been involved in the approval of hundreds of vaccines and pharmaceutical products and a significant number of studies have been performed on behalf of pharmaceutical companies. In addition, Quality Control provides validation services in a wide range of analytical activities as well as validation of the final product characteristics.

Quality Control is an independent unit and is comprises of 3 quality control laboratories and a clean room sterile area with grade zones B/C/D.

pH
Total Organic Carbon (TOC)
Osmolality
Detection of heavy metals

Bacterial Endotoxins – EUROPEAN PHARMACOPOEIA 2.6.14
Sterility – EUROPEAN PHARMACOPOEIA 2.6.1
Microbial enumeration tests – EUROPEAN PHARMACOPOEIA 2.6.12
Special pathogens – EUROPEAN PHARMACOPOEIA 2.6.13

Abnormal Toxicity – EUROPEAN PHARMACOPOEIA 2.6.9

1. METHOD OF STERILITY VALIDATION

The purpose of the method is to control the sterility in vaccines, in medicaments and auxiliary materials (such as filters, syringes, implants and other objects), i.e., no contaminating microorganisms are found in the sample examined under the conditions of the test, which are described in paragraph 2.6.1 (Sterility) of the European Pharmacopoeia (Ph. Eur.).

2. METHOD OF BACTERIAL ENDOTOXINS DETERMINATION

The method and the way in which samples of water for injections, injectable pharmaceutical products and other medical devices (filters, syringes, etc.) are performed to determine bacterial endotoxins based on the kinetic colorimetric method, as described in the European Pharmacopoeia (Ph. Eur.), §2.6.14, Method D.

Quality Control staff comprises highly motivated experts with PhD and MSc, experienced in chemistry, pharmacy, biology and related sciences. All experts in pharmaceutical analysis are aware of the latest developments through continuous training.