Critical Process Parameters (CPP)
Critical Process Parameters (CPP) as well as Critical Quality Attributes (CQA) are identified, defined and finally determined within the second phase of Process Validation according to FDA. Factors affecting patient safety or product efficacy through API are relevant for critical steps, CQAs and CPPs in order to follow FDA's science-based and risk-based regulatory approach, which also is consistent with the ICH Q7A Section 12.1.
FDA considers all thinkable parameters in its guidance (which lets recognize that FDA strives for completeness), but in practical work not all but certain values are really important. Those parameters are crucial and therefor are called critical: Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) and furthermore considered here according to EMA´s terminology.
During the Process Qualification which is according to FDA the second phase of Process Validation in a pharmaceutical environment Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) should be identified and have to be determined.
Only those factors which ultimately affect patient safety or product efficacy through API quality are relevant to critical steps, CQAs, and CPPs. By defining and focusing on criticality according to quality only, it is possible to closely follow FDA's science-based and risk-based regulatory approach, which also is consistent with the ICH Q7A Section 12.1.
Fundamental in the determination of CQAs and any resultant critical steps and CPPs is relating process variables to their potential effects on the end product, the API.
The critical parameters/attributes should normally be identified during the development stage or from historical data, and the ranges necessary for the reproducible operation should be defined. This should include:
- defining the API in terms of its critical quality attributes;
- identifying process parameters that could affect the critical quality attributes of the API
- determining the range for each critical process parameter expected to be used during routine manufacturing and process control.
According to ICH Q6A, some attributes should be considered critical, regardless of the drug product end use. Additional attributes should be considered critical, depending on the final drug product.
The first phase is to identify potential CPPs - the specific process parameters that may affect particular CQAs. The evaluation takes into account experimental knowledge as well as practical experience.
With importing process data into PANDA system which helps to monitor and evaluate them in a comfort manner Critical Process Parameters can easily be detected.
Integration and evaluation of CQA by PANDA
PANDA allows calling in production process data from different sources like e.g. EBR, MES, BDE, OSI/PI and keeping it up to date.
The PANDA system supports the applicant
- Improving, testing and ensuring data quality
- Unifying by mapping of varieties in given names
- Identifying relevant process parameter (CPP) within the multitude of information
- Analyzing single value as well as multi value data
- Surveying of attributes by analysis reports on a regular basis
- Monitoring the stability of products
Process parameters can be put in relation to quality attributes (CQA) in order to show dependencies.
Incoming data which is partially raw data will be - if nessesary - compressed and is undergoing a customer defined mapping which produces consolidated sets of data. This consolidated and standardized data from other sources can rapidly and in an easy way be visualized in user defined data grids or trending graphics. A large variety of data treatments is possible which is worthwhile in order to obtain sought results.
Because there is no standardization in data sources, it is important, that a great diversity of data sources and systems can be used via the open interfaces of PANDA. Mapping allows standardization and homogenization of until than heterogeneous data.