Pharmaceutical Product Development
Xybion’s Formulation Management Software module allows scientists in the product development departments in biopharmaceutical and generic drug companies to perform step-by-step online formulations based on established methods.
The laboratory inventory management system functions allows tracking of laboratory materials, including material receipt, registration of the material supplier and manufacturer and movement of the material among laboratory areas.
- Track movements of drug substances, vehicles and excipients. by container or by user and date basis
- Hazard statements and special handling instructions, often similar among classes of compounds, are easily prepared with the “master paragraph” functions
- Special functions are available for the development and execution of drug formulation work sheets based on inventoried materials
The substance management capabilities provide capability for describing laboratory materials that are to be inventoried and tracked by recording receipt, movement and use of materials.
- Labels and inventory reports may be generated immediately following the registration of a new material or new container
The extremely flexible and user-friendly interface to define standard formulation procedures.
- This concept allows clients to design and implement a workflow matching the formulation process and recording the desired details; the least of which is al of the weights performed during the formulation and additionally recording equipment, comments, pH, stir-times, etc.
Target lists define the amount of the substance and vehicle required to formulated concentrations of new substances.
- Target list calculations include direct addition (where the substance is mixed with the vehicle directly in the formulation container), stock dilutions, and serial dilutions
- Using the concept of the target list which specifies all of the calculated quantities to be used in a formulation and the method which enforces and records the work-flow, the Target List execution provides a multi-part Windows screen that provides an overview of the calculated measurements to perform, the steps that need to be performed and then a detailed, step-by-step instruction sequence
- Highly customizable to meet site-specific SOPs
- Materials Master Records
- Materials inventory management & tracking
- Materials archival and disposal records
- User-defined template formulation instructions
- Wide variety of formulation types
- Online execution of the formulation
- Built-in supervisory reviews & approvals
- Built-in bar code labeling & scanner interfaces
- Built-in bi-directional interface for balances
- Fully integrated component of the Pristima® Suite
- 21 CFR Part 11 electronic signatures and audit trail compliant