Prescription & Formulation Management
The ratios of active ingredients (API), excipients, solvents and other auxiliary substances used in pharmaceutical production are determined in accordance with GMP and FDA regulations. Recipe management and formulation controls are systematically carried out in order to maintain quality and ensure traceability of processes in production processes. Formulation changes are recorded and version tracking is ensured, and production recipes are integrated into processes to ensure consistency and quality in production.
Features
- Master Batch Record (MBR) Management
- Recipe & Formulation Identification and Version Tracking
- Critical Process Parameters (CPP) Identification
- Material & Quantity Calculation (BOM - Bill of Materials)
- Manufacturing Standards & Process Approvals
- Formulation Cost Analysis & Optimization
- Transaction History & Automatic Notifications
Master Batch Record (MBR) Management
All recipe details, raw material ratios and production steps of the production process are defined in the MBR (Master Batch Record) system. Thus, production processes are standardized and full traceability is ensured.
Recipe & Formulation Definition and Version Tracking
Formulation information is recorded for each product and past changes can be tracked with version management. Changes made are recorded in the system to ensure that the correct recipes are used in production.
Critical Process Parameters (CPP) Identification
Critical process parameters such as temperature, pressure, humidity, which directly affect quality in production, are determined and defined in the system. The determined CPP values are monitored throughout the process and compliance checks are provided.
Material & Quantity Calculation (BOM - Bill of Materials)
The quantities of materials to be used in production are calculated via BOM (Bill of Materials). In this way, the correct amount of raw material is allocated for each production batch and material management is optimized.
Production Standards & Process Approvals
Production standards in accordance with GMP, FDA and other regulations are defined and in-process approval mechanisms are created. Thanks to process approvals, quality control processes are carried out in an integrated manner with production.
Formulation Cost Analysis & Optimization
Cost optimization is done by calculating production costs on a recipe basis. Efficiency is increased by evaluating alternative raw materials and production processes.
Transaction History & Automatic Notifications
All formulation changes and recipe processes are recorded in the system, making past transactions traceable. Relevant teams are informed of updates with automatic notifications.