Fill & finish lines for sterile dosage forms have already been increasingly in demand on the market in recent years.
In order to conserve internal resources at the pharmaceutical operators, it is possible to purchase qualification packages from the suppliers of the associated machines and systems; even if the responsibility for carrying out the qualification in order to meet the high regulatory requirements remains with the client.
This presentation uses a current Fill&Finish project to provide practical examples of the points to be considered when integrating such a supplier qualification package and the corresponding documents into an overall qualification concept of the operator and how this can be designed efficiently and describes the greatest challenges for all project participants in the qualification process.
In addition, the advantages and disadvantages of different qualification approaches, (partial) qualification already at the supplier compared to the more traditional sequence (FAT / delivery / SAT / IQ / OQ) are presented.