The conventional approach for pharmaceutical manufacturing long-cantered on batch processing with laboratory testing conducted on collected samples to evaluate quality. This is mostly based upon agreeing how a process will be conducted in advance and then evaluating the success or failure of this through end product testing. In contrast, the Process Analytical Technology (PAT) concept enables pharmaceutical manufacturing to develop a system for designing, analysing, and controlling manufacturing through timely measurements (that is, during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.
PAT can assist with
- Improving the scientific basis for establishing regulatory specifications,
- Promoting continuous improvement,
- Improving manufacturing while maintaining or improving the current level of product quality.
An example of ‘real time’ monitoring is with on-line total organic carbon measurements to assess the quality of a Water-for-Injections system. A further example is with capacitance radio frequency to assess cell culture biomass in real-time. Related to this is the concept of bringing parts of the Quality Control laboratory to the process floor. This can be achieved by having equipment that is portable, continuous, miniature, and modular.
Real-time monitoring allows for:
- Making timely measurements during processing,
- Measuring critical quality parameters,
- Measuring performance attributes,
- Assuring acceptable end product quality,
- Using designed sensors, probes, and other devices or equipment to obtain real-time data
- Conducting data collection and measurements in-line or on-line,
- Monitors or controls individual operations or all operation in a process.
Parameters include:
- Critical quality attributes are the physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution in order to ensure appropriate quality.
- Critical process parameters are parameters where the variability can impact upon the critical quality attribute. Therefore, monitoring these, as identified through risk assessment, can help to ensure that process control is achieved.
Studying the process in real time further allows for greater product and process understanding.