Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Effective Change Control Management of Product Information Texts ***
Dr. Antje Wallstab (Abschlußjahr: 2003)
Product information texts such as SmPC (Summary on Product Characteristics), PIL (Patient Information Leaflet) and labelling, form an integral part of applications for marketing authorisation within the European Union (EU). Change control management of product information texts is a very important issue regarding the safety of medicinal products. The European and German legal framework defines obligations for the fundamental content of the SmPC, PIL and labelling. The present thesis discusses the relevant German and European legal basis for regulatory and pharmaceutical rules. Special German requirements are emphasised.
Post-marketing surveillance activities resulting from the responsibility of the Marketing Authorisation Holder (MAH) to improve product safety and their consequences on the adaptation of product information texts are summarised. A separate Chapter is dedicated to those pharmacovigilance aspects following marketing authorisation that are supervised by the competent authorities. The monitoring of the company core safety reference document and the effect on national texts is discussed.
The thesis also deals with organisational precautions of change control procedures of product information texts that are part of the granted marketing authorisation. The factors that have to be considered for an effective change management in national and international pharmaceutical companies are analysed. The present work summarises the general requirements for change control procedures and presents the basics of a Quality Assurance (QA) system covering not only the internal processes by the MAH, but also quality assurance measures by external suppliers. The criteria for the selection of suppliers and the separation of responsibilities within the QA agreement between MAH and suppliers are discussed. In particular, the correlation between the agreed duties including the definition of timelines and an effective change management is emphasised.
Essential matters of Standard Operating Procedures (SOP) related to the management and maintenance of approved product information texts including dedicated processes are presented. The definition of organisational preventive measures, including workflow, checklists and comparative figures, offer the possibility to investigate the potential for optimisation in other pharmaceutical companies. A survey of different pharmaceutical companies was performed and analysed in respect of best change control practise.
Finally, the relation between published approved texts and the amended German liability law is illustrated. It is recommended for companies to accelerate and reorganise their procedures to prevent unnecessary financial consequences of liability claims resulting from non-compliant information given to health professionals or patients.
Pages: 43,
8 Annexes