Quality Control Department
LICENSED AUTHORITY/CERTIFICATION / ACCREDITATION / MEMBERSHIP
Quality control operates on behalf of National Organization for Medicines (E.O.F.) to third parties and pharmaceutical companies. The Quality Control Department has licensed authority by the Institute of Pharmaceutical Research and Technology (I.F.E.T) to perform controls on vaccines and biological products.
The department 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 has accreditation ISO 17025: 2005(516-3) from E.S.Y.D (Hellenic Accreditation System).
The Department is member of HellasLab and Eurolab the European Federation of National Associations of Measurement, Testing and Analytical Laboratories.
SCOPE / OVERVIEW
The scope of Quality Control Department of the Hellenic Pasteur Institute is to assure that vaccines and other pharmaceutical products conform to specifications in line with current Greek and European pharmaceutical legislation. The department provided reliable laboratory analyses based on principles of good professional and scientific practice, 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 Department control and release around 70% of the vaccines distributed to the Public Sector. Within the many years of operation, Quality Control Department have 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. Since 1995, tests have been carried out for the immunological response of vaccines. Up to now, 6,000 serum have been tested, mainly for protective antibodies to Tetanus, Diphtheria, and Bordetella. Quality Control Department provides validation services in a wide range of analytical activities as well as validation of the final product characteristics.
GOOD MANUFACTURING PRACTICES
Quality Control Department is an independent unit and is comprises of 3 quality control laboratories and a clean room sterile area with grade zones B/C/D. Our laboratories operate under strict quality procedures which meet GMP requirements. 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. 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. Compliance with these principles and guidelines is mandatory within the EEA and the national authorities of each country are responsible for their enforcement.
PHYSICOCHEMICAL CONTROL LABORATORY
- Total Organic Carbon (TOC)
- Atomic absorption with graphite furnace- Detection of heavy metals
MICROBIOLOGICAL CONTROL LABORATORY
- 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
BIOLOGICAL CONTROL LABORATORY
- Abnormal Toxicity – EUROPEAN PHARMACOPOEIA 2.6.9
METHOD OF VERIFICATION OF STERILITY OF VACCINES, MEDICINES AND HELPFUL MATERIALS
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., not to isolate the sample of microorganisms to be tested under the conditions of the test, which are the ones described in paragraph 2.6.1 (Sterility) of the European Pharmacopoeia.
METHOD OF DETERMINATION OF BACTERIAL ENDOTOXINS OF SAMPLES OF WATER FOR INJECTIONS, INJECTABLE PHARMACEUTICALS AND OTHER MEDICAL DEVICES
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 of bacterial endotoxin control as described in the European Pharmacopoeia, §2.6.14, Method D.
Quality Control Department staff comprise highly motivated experts-specialists 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.
State of the art technology under GMP environment. Quality Control Department yearly invest in new technology. Therefore, the available instrumentation is continuously expanding, while we increase our capacity by maintaining multiple units of the same type. All systems follow the GMP requirements, such as the annual operational and performance qualifications.
Head of Department (Qual. Control Manager:QC/Quality Person: QP/Quality Assurance Manager :QA):
Head of Animal control:
Specialist technical scientist:
Dr Dimitris Sofianos
Head of Quality Control Department