Prescription Process Development of Generic Drug

The evaluation of quality standards is an important part of the consistency evaluation of generic drugs, and the production process and critical process parameters (CPPs) directly affect the quality of products. Therefore, it is necessary for generic drug manufacturers to identify these important parameters during the product development and process. The evaluation of the prescription process research and verification is required to provide as an important evaluation content in the review report. Currently, an effective strategy to address this issue is the small-scale research of the prescription process, where the identified critical process steps and CPPs are optimized and validated by conducting laboratory-scale experiments. In addition, the choice of production equipment and prescription methods are accurately identified and controlled.

Our Target

Alfa Chemistry provides sufficient research data to support the development of your generic drug's prescription process. And the purpose of our prescription process research is to ensure that the final products can be obtained under the control of production conditions and parameters.

• Research and optimization of the process parameters
• Identify CPPs affecting the product quality
• Establish the production process operating range
• Determine the quality standard control items

Figure 1. Product development process for generic companies. (Elnakib, I. 2012)

Alfa Chemistry's Services

Identification of Critical Process Parameter (CPP)

The main objective of consistency evaluation is to assess whether the prescription process can generate the same quality product as the target Reference Listed Drugs (RLDs). Variation in CPP will affect critical quality attributes, so they need to be monitored and controlled to ensure the quality of the products. In prescription process studies, the identification of CPPs helps to determine appropriate process control methods and quality assurance system. Our experts provide CPP identification and evaluation services for the RLDs to provide strong evidence for the consistency declaration of your generic drug.

Small-scale Research for Process Development

The prescription process is a key step that affects the quality of preparations. It mainly includes the following contents: confirmation of optimal formulation composition; evaluation of critical process parameters and confirmation of key process steps. Alfa Chemistry has equipped with the equipment and instrumentation for prescription process development of generic drug, and provides small-scale research services.

• Analyze key process flow such as granulation, tableting, coating, etc.
• Analyze the critical processes steps: determine CPPs and the appropriate operating space
• Process control: operate in the operating space, implement control strategies such as feedforward and feedback, and ensure that the critical quality attributes of the product are consistent.

Our Advantages

• Complete process description including key instrumentation and equipment
• Preliminary validation and evaluation of the prescription process
• Data to support the control of CPPs