Use of Quality Risk Management for ensuring Good Distribution Practice - Brossura

Busuttil, Adrian; Serracino-Inglott, Anthony; Azzopardi, Lilian M.

Brossura

ISBN 10: 3848493098 ISBN 13: 9783848493098

Casa editrice: LAP LAMBERT Academic Publishing, 2014

Riassunto

The European Commission introduced Quality Risk Management (QRM) for medicinal product wholesale dealers (MPWD) to ensure Good Distribution Practice (GDP), through the publication of the new EU-GDP guidelines in March 2013. This book serves as a template in the setting up of a QRM system by a MPWD. First, a Quality Management System (QMS) consisting of a number of Standard Operating Procedures (SOPs) regulating each distribution activity is set up. Then medicinal product distribution steps and risks are identified. Finally a QRM exercise is applied to the identified risks. Risks are classified as being acceptable or not acceptable. Corrective and Preventive action is proposed to mitigate unacceptable risks in the distribution of medicinal products. A model Quality Risk Management SOP and a Disaster Recovery SOP are proposed and also presented in this publication.

Su questo libro

L'autore

Adrian Busuttil graduated in 2004 and has 10 years experience working in community pharmacy, medicinal products manufacture and wholesale dealing. He completed a Master of Science degree in Pharmacy in 2013. Anthony Serracino-Inglott is Professor and Lilian M. Azzopardi is Professor and Head of Department of Pharmacy at the University of Malta.

Dettagli dell'edizione

• Editore: LAP LAMBERT Academic Publishing
• Data di pubblicazione: 2014
• Lingua: Inglese
• ISBN 10: 3848493098
• ISBN 13: 9783848493098
• Rilegatura: Copertina flessibile
• Numero di pagine: 272
• Contatto del produttore: non disponibile
• Persona responsabile: KreGa Onlinehandel GmbH; 4950000000000; info@krega-onlinehandel.de; ; Birkenweg 31; Brakel; 33034; Germania