Master Batch Record (MBR)

Master Batch Record (MBR) module is configurable for any product and batch size (fixed and variable). Different configurable MBR templates such as API MBR, formulation MBR, medical devices MBR, etc., are available to cater to various industries.

1. Reusable Templates

CaliberBRM’s MBR offers configurable and reusable templates. These templates are available for line clearance, process instructions, deviation, dispensing, and index page. Different manufacturing companies can configure their MBRs and design their own Batch Record Templates (BRTs).

2. Yield Templates

Yield reconciliation is essential at every stage of manufacturing. In order to arrive at yield reconciliation, the user configures yield templates.  The templates have embedded formulae  to calculate Yield. It avoids manual intervention and facilitates complete automation of the process.

3. Process Stages

Using CaliberBRM’s MBR, a manufacturing company can design different process stages such as dispensing, blending, granulation, sifting, binder preparation, compression, mixing, coating, filling, sealing, etc., in a process manufacturing cycle. It, thus, makes Master configuration more efficient.

4. Location and Equipment Mapping

Configurable Master Batch Record makes it possible to map equipment to location. This exercise involves one-time effort. During Master’s preparation and execution, the authority can trace the availability and map the equipment to location accordingly.

5. Bill of Materials (BOM)

Bill of Materials (BOM) contains information of quantities of raw materials like APIs, excipients, primary packing materials, secondary packing materials, and other materials required in a batch production. The user can adjust BOM as per batch size dependent on the different material types like  drug substances (with formulae for potency, volatility, etc.), drug products (formulations, generic, excipients), packing, etc. With CaliberBRM’s MBR, configure every aspect of BOM.

6. Area and Equipment Logs

CaliberBRM tracks and reports the area and equipment logbooks for operational and non-operational usage activities. It covers all the phases such as production, packing, cleaning, calibration, clearance, and also covers preventive maintenance areas. The system tracks area usage, equipment usage, checklist issuance, and execution.

7. In-process Quality Check (IPQC)

In-process quality controls (IPQC) during different stages of production ensure that complete batch production is going on smoothly. It is possible to carry out these checks with or without instrument connectivity. The user performs IPQC by designing test protocols, sample withdrawal scheduling, test patterns, sample analysis as per workflow and acceptance criteria defined in the system. The system also allows to perform automatic exception approval for the failed samples and test results trends and charts.

8. Assigning Roles and Privileges

MBR helps assign roles and privileges to access the stage-wise tasks in execution review. Only the appropriate personnel can securely access the templates.

9. Validation Workflow

The system can run a validation cycle so that the MBR doesn’t have any transcriptional errors, etc. The MBR, once approved, is moved to the production or issuance.

10. Master Batch Record Print

Take a print of the designed Master Batch Record in CaliberBRM system for reference or reviewing purpose.