Our database manages the complexity of relationships between excipients and their valid dosage forms, functionalities, and manufacturing methods. For each valid relationship, the database associates risk factors and RPN analyses, along with references and mitigation strategies. Our decision support tool guides users through selection of valid options and produces a full risk analysis report for the chosen excipient, dosage form, functionality, manufacturing method, and grade. Click here to begin. |
* Grades that remain valid as users select excipient, dosage form, functionality and manufacturing method
* Suppliers for each grade
* Rules for the valid functionality, dosage forms and manufacturing methods for each choice of excipient
* Grade properties and measurements
User Documentation User Guide |
Instructions for using the Excipient Risk Assessment Tool |
Master Lists Excipients, Dosage Forms, Functionality, Manufacturing Methods, Grades |
Spreadsheets that list the excipients, grades, functionality categories, dosage forms and manufacturing methods that are available in the risk assessment database. In the Grades Master List, the Excipient and Supplier for each grade are also listed. |
Knowledge-based Rules Grade-Functionality, Grade-Dosage Form, Grade-Manufacturing Method, Functionality-Dosage Form, Functionality-Manufacturing Method, Manufacturing Method-Dosage Form |
Spreadsheets with rules that identify all valid relationships between grades, functionality, dosage form, and manufacturing method. The relationships determine the selections that can be made in the decision support process and the combinations that require risk assessment data. |