Training description: Monitoring of the conditions of the manufacturing environment is one of the key aspects of the Good Manufacturing Practice (GMP). The monitoring covers installations and systems which are critical for product quality, including air conditioning, purified water / water for injection / clean vapour, compressed air and protective gases systems as well as device, facility and staff spaces. The data collected during monitoring are subjected to a periodical review and analysis in order to show that the manufacturing environment conditions are stable and compliant with the acceptance criteria adopted.
In order to organise and present the monitoring data, statistical methods are used. They allow for the development of a correct model of the system’s operation and for the determination of control limits, which may indicate appearance of adverse trends and signal irregularities in the process/system, when they are exceeded. The methods of calculating control limits should be standardised, free from arbitrariness and applied consequently, together with a correct description of corrective and preventive measures to be taken when the limits are exceeded.
The course is intended for persons who analyse data collected during periodical environmental review of air and water quality and other utilities. During the course, requirements concerning monitoring of a manufacturing environment will be presented together with data analysis methods which can be applied for assessment of trends, seasonality, outliers, process modelling and for determination of control limits (alarm and action) for on-going monitoring of the manufacturing environment. Apart from typical statistical methods, various graphic methods will be presented, which can help establish whether there are any trends and if there are, to establish their nature. 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 monitoring of the manufacturing environment conditions of air, water and other utilities.
Requirements: ability to work with a computer in the Windows environment.
- What are the basic GMP regulations concerning monitoring of air, water and other utilities
- Which installation/system parameters should be included in an installation/system monitoring programme
- What are the criteria for acceptance of installation/system parameters for sterile and non-sterile drug forms
- How to define sampling points and frequency for particular installations/systems/li>
- Which risk analysis methods should be applied to define sampling points and frequency
- How to document and report test studies for particular installation/system
- What is the scope of a periodical installation/system review
- What are the typical elements of a periodical installation/system review report
- Which statistical methods should be applied in an installation/system monitoring data analysis
- Which conditions must be complied with in order for statistical methods and a data analysis to be reliable
- How to define alarm / action limits in installation / system monitoring
- When corrective / preventive measures should be taken
- Which corrective / preventive measures should be taken after control limits are exceeded
- How to identify the influence of seasonality on the stability of installation/system operation
- When it is possible to deem an installation/system as stable and able to reach specific limits
- How to cope with difficult cases of a non-standard behaviour
- How to use methods of statistical data and risk analysis to justify analysis reduction
- Examples of an installation/system monitoring plan and of a periodical environmental monitoring report
- Graphic methods of showing environmental monitoring trends / results
- Methods of evaluation of autocorrelation, steady trends, seasonality, outliners
- Parametric / non-parametric methods for establishing control limits
- Control sheets applied in installation / system monitoring
- Development of a change dependence model and its correctness