Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Supervisors info:
Ηλίας Κοττέας, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Γαρυφαλλιά Πουλάκου, Επίκουρη Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Ιωάννης Γκιόζος, Ακαδημαϊκός Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Ανασκόπηση πρωτοκόλλων πιστοποίησης ποιοτικού ελέγχου τελικών προϊόντων στον Ευρωπαϊκό χώρο
Translated title:
Review of final products quality control certification protocols in the European area
Summary:
To protect public health and ensure the availability of safe and effective high quality medicines for European citizens, all medicines must be approved before they can be placed on the EU market.
The final product is defined as the medicinal product which has undergone all stages of production, including packaging in the final container. Each batch of finished product must be accompanied by a batch certificate issued by the manufacturer and signed by a qualified person. The final product batch certification represents the quality release of the batch before the batch is put up for sale or distribution and will be issued after a complete qualitative and quantitative analysis of all active and other relevant items. The batch certificate will certify that the batch meets the specifications and has been manufactured in accordance with the product marketing authorisation, country of importation, detailed product specifications, analytical methods indicated, detailed results obtained and a statement that the processing batch, packaging and quality control files were reviewed and found in accordance with EU GMP principles or equivalent standards to support regulatory processess in importing countries.
The GMP, ie the Rules of Good Manufacturing Practice, concerns the production process, the quality control and the packaging of the product and ensures that the products are produced and controlled according to the quality standards. Quality control is the part of the GMP that includes all the techniques and activities applied, to check whether the conditions are met to ensure the quality of materials to be used and products to be sold or distributed based on specified specifications in accordance with applicable law. The specifications are designed to ensure product quality and must comply with GMP regulations.
Main subject category:
Health Sciences
Keywords:
European drug regulatory system, Final product batch certification, Quality control, GMP, Quality assurance, Specifications, Controls, Qualified person
File:
File access is restricted only to the intranet of UoA.
Diplwmatiki_ergasia (1) (2).pdf
1 MB
File access is restricted only to the intranet of UoA.
