The aim of the course is to familiarise its participants with guidelines concerning product quality review and statistical data analysis methods, making it possible to identify and control variability sources, transform the obtained data into knowledge and process understanding.

Training description: The quality management model proposed in ICH Q10 was implanted to Chapter 1 of the Good Manufacturing Practice requirements. One of the basic elements of the Pharmaceutical Quality System is the development of an efficient programme for monitoring product quality and process functioning. It involves collection of data, their effective transformation into knowledge on product quality and process functioning, and constant quality improvement throughout the product life cycle. According to ICH Q10, the programme for monitoring processes and product quality should make it possible to:

• determine a strategy of control of process parameters and product attributes by applying the quality risk management rules;
• provide tools for measuring and analysing parameters and attributes identified as part of the control strategy;
• analyse process parameters and product attributes in order to verify the on-ongoing control;
• identify variability sources influencing the process functioning and the product quality in order to reduce or control the variability;
• take feedback on the product quality into consideration: complaints, withdrawals, deviations, nonconformities, disqualifications, audits, inspections;
• manage knowledge effectively in order to expand the knowledge on the process functioning, the design space and the innovative approach towards process validation

The aim of the course is to familiarise its participants with guidelines concerning product quality review with a special focus on application of statistical data analysis methods. The course combines practical knowledge on specific issues concerning the pharmaceutical industry with the knowledge of data analysis methods, presented on the basis of data from the branch

Every statistical issue will be at first discussed theoretically, and then developed during practical classes. After the course, the participants will be able to propose appropriate data visualisation and statistical evaluation techniques to be applied in a product quality review.

Requirements: ability to work with a computer in the Windows environment.

Training programme:

• Basic product quality review requirements
• Which documents and data should be reviewed and to a what extent
• Which risk analysis methods should be applied in process and product assessment
• Which product/process parameters should be included in a periodical product review
• Which statistical methods should be applied in a product/process parameters analysis
• How to interpret statistical analysis results
• How to categorise a process based on a statistical analysis results
• Which actions should be taken in case of unstable and/or incapable processes
• Which qualitative metrics should be applied in process and product assessment
• How to determine control limits for on-going process monitoring
• Which procedure should be applied after exceeding control limits
• How to integrate on-going process verification with periodical product review
• Examples of periodical product review/on-going process verification

• Statistical inference
• Methods applied in process modelling
• Methods applied in a process model analysis
• Process stability analysis with the use of control charts
• Cp, Cpk versus Pp, Ppk process capability analysis