The preparation of a Product Quality Review is a requirement that was already included in the EU GMP guideline in 2006. In the USA, the comparable document is called the "Annual Product Review", which was already mandatory before 2006 and had to be submitted annually.
The PQR is intended to provide evidence that the current processes are suitable for meeting the set specifications and to identify trends in order to prevent negative developments at an early stage, e.g. through process improvements. The responsibility lies with the Competent Person and the marketing authorization holder, who are jointly responsible for the preparation and evaluation of the annual data.
Data to be used are often found in very heterogeneous sources, such as process validations, manufacturing documentation, analysis, stability reports. Therefore, it is usually not easy to evaluate all relevant data completely and to combine them in a specific report related to the purpose. Further, data has to be filtered, consolidated, summarized and commented. The result has to be visualized transparently and prepared ready for inspection.
Concept Heidelberg will be holding a seminar on this challenging topic on March 7 and 8, 2023. It is intended to enable the creation of a PQR in accordance with the requirements and supports this with practical examples.
Dr. Martin Melzer, Principal Consultant at gempex, explains all the relevant background information, draws parallels with the American Annual Product Review, and shows which contents are to be consolidated and dressed up in suitable reports. The concerns of the distributors are addressed, as well as those of the contract manufacturers, who may only want to prepare a subset of all batch results produced for their clients, and who may want to record this in advance in corresponding responsibility delimitation contracts.
An intensive workshop, conducted by experienced lecturers from the field, which complements what has been heard with personal experience, shows the importance of continuous data collection (electronic, paper-based or hybrid). It introduces statistical analysis and shows examples and best practices from other companies on how a PQR has been implemented there.
The inspectors' view is not missing either. After all, the PQR is often used as an introduction to an inspection, as it provides a comprehensive view of the manufacturing process. Inspection focal points, dos & don'ts, and the experience gained from inspections are discussed.
At the end, participants will be able to set up a PQR in their own company using a sample PQR and an SOP published by the BAH.
Further information and a registration option are provided in the program for the event.
The gempex expert team will be happy to answer any questions about PQR Product Quality Review via contact@gempex.com.