Critical parameters are parameters that affect the quality of the product. With the publication of ICH Q8(R2), CPP has become an important term in the pharmaceutical industry, which is defined as a process parameter.The main purpose of generic drug process research is to obtain a product of the same quality as the reference marketed drug (RLD) by designing a formulation process consistent with it. In the RLD prescription process research, experts conduct in-depth research and accurate identification of CPP of the RLDs to determine the appropriate process control method and quality monitoring program for the proposed generic product. Therefore, the FDA has a clear requirement that CPP should be accurately identified and properly controlled to ensure the process consistency. At Alfa Chemistry, through the collection and analysis of information on the prescription and production process of the RLDs, combined with a variety of analysis strategies and tools, our scientist can accurately confirm the CPP of the RLDs to help optimize the production process of your generic drug products, and provide strong evidence for the consistency declaration of your generic drug.
Figure 1. CMA, CPP, and CQAs of pharmaceuticals. (Alejandro, B.; et al. 2020)
Alfa Chemistry's Capabilities of Prescription Analysis
- Expert knowledge of risk assessment methodologies
- Expert subject knowledge of the processes involved
- Knowledge of related regulations and quality policies
- Deep understanding of quality risk prioritization
Our Services
Evaluation of Potential CPPs
At Alfa Chemistry, our experts mainly refer to the information of development and commercial production process of the RLDs. The information of the RLD prescription is investigated and obtained through the US FDA instructions, chemistry, manufacturing and controls (chemistry, manufacturing and controls, CMC) reports, and the US Patent and Trademark Office (USPTO).
Identification of CPPs
- Design of experiments (DoEs)
DoE method is used to isolate prescription factors and process factors, and analyze the influence of them on key responses related to the drug substance or product. - Risk assessment
We identify the CPP by determining whether the variation of the process parameter has a significant impact on the product quality. Here is our standard workflow of the risk assessment: - Determination of primary factors, secondary factors, non-primary factors via performing some simple experiments
- We provide a risk assessment matrix to analysis the risk assessment results:
If a CPP is identified as having a medium (M) or high (H) risk during the assessment process, this parameter can be identified as a CPP.
Why Choose Alfa Chemistry
- Standard Laboratory
- Fast Turnaround with short cycle times
- Competitive service charges
- Customer Satisfaction Rate above 99.4%
References
- Alejandro, B.; et al. Formulation and Evaluation of Loperamide HCl Oro Dispersible Tablets. Pharmaceuticals. 2020. 13. 100.
- Critical parameters in manufacturing process validation of different forms of pharmaceutical injectable products - to assess products' risk framework. Master degree in Pharmaceutical Engineering. University of Lisbon. 2014.
