The purpose of the prescription process study is to ensure that the product meets the quality requirements under the control of the preparation conditions and parameters. Therefore, it has an important significance to the quality control of the final product. Therefore, process evaluation has become an indispensable part in the registration and review of generic drugs, both in R&D and regulation. Based on the importance of prescription process research, the process evaluation, prescription screening, preparation process research and validation needs to be reflected in the review as an important evaluation content in the consistency evaluation of pharmacology. Alfa Chemistry provides comprehensive generic prescription process research services, and we perform the development, optimization and validation of prescription process after completing a thorough research and analysis of the prescription of the Reference Listed Drugs (RLDs). The optimal prescription process is provided when the scale-up research is finished.
Figure 1. Steps involved in the development of prescription process of a potential generic product. (Danielle, P.; et al. 2013)
Alfa Chemistry's Services
In the process of prescription process research and prescription screening of generic drugs, suitable and stable analytical methods are essential. Alfa Chemistry develops and validates a variety of analytical methods, including relevant substances, content, moisture, residual solvents, etc.
- Identify and study the process parameters of the RLDs to determine the critical process parameters that affect the product quality
- Evaluate the parameters of each production unit to ensure the effectiveness of the next operation unit
- Carry out process durability studies to determine the scope of process operation and quality standard control items
Process optimization helps to save cost and time for the subsequent product development and production. Alfa Chemistry provides drug-excipient compatibility testing and prescription screening services during the prescription process optimization process to obtain a optimized prescription process that is supported by a variety of test data.
After the process optimization is completed, we establish the production process flow and provide experimental data to support commercial production of the product by scaling up the production scale, establishing operating ranges for process parameters, determining process durability and adequate process control points.
- Critical process parameters: reproducibility testing of the production process is performed by scaling up the production equipment to determine the range of process parameters
- Quality control of formulation intermediates: moisture control of raw materials, etc.
- Operation control in the production process: environmental temperature, humidity, cleanliness requirements in production
- Evaluation of samples and data analysis to optimize the production process
Process validation is employed to demonstrate the robustness and reproducibility of product from batch-to-batch. After determining the production process through process scale-up studies, our experts provide reliable process validation services. Through process control of sample production and quality assurance of samples, we fully evaluate whether the process has good reproducibility and the stability of product quality. With years of project experience, we are able to provide test results that meet quality standards (consistency with the RLDs) and provide report sheets.
- Scale of process validation: pilot or above
- Batch of process validation: provide at least three batches of samples of continuous production to meet the quality requirements
- Process control and confirmation of critical process parameters in process validation
- Delivery of SOPs of production engineering
Reference
- Danielle, P.; et al. How Generic Drugs Are Made. US Pharm.2013. 38(6).
