Active Pharmaceutical Ingredients:
The API design process involves selecting the appropriate ingredients and recipients, determining the optimal dosage form (e.g., tablet, capsule, liquid), and optimizing the API to achieve the desired pharmaceutical and pharmacologic properties.
Process development:
Once the Research and Development has been done the manufacturing process must be developed and optimized to ensure consistent product quality and yield.
Stability testing:
Stability testing is an essential component of R&D, as it helps to determine the shelf life and storage conditions of the drug product.
Regulatory compliance:
R&D must be conducted in compliance with regulatory guidelines and standards, such as Current Good Manufacturing Practices (cGMP), to ensure the safety and efficacy of the drug product.
Quality control:
Quality control measures, such as in-process testing and finished product testing, are essential to ensure the consistency and quality of the drug product.
Technology transfer:
Technology transfer is the process of transferring the API and manufacturing process from R&D to commercial-scale production. This process must be carefully managed to ensure that the drug product maintains its safety, efficacy, and quality throughout the manufacturing process.
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