CaliberBRM’s Master Batch Record (MBR) is configurable for any product and batch size (fixed and variable). It facilitates API MBR, Formulation MBR, Medical devices MBR and is customizable for different industries.
CaliberBRM’s MBR offers configurable and reusable templates. These templates are available for line clearance, process instructions, deviation, dispensing along with the header, footer and index page. Different manufacturers can configure their MBRs and design their own Batch Record Templates (BRTs).
Yield reconciliation is essential at every stage of manufacturing. In order to arrive at yield reconciliation, yield templates are configured. Yield calculations can be done easily using the embedded formulae in these templates. This avoids manual intervention and facilitates complete automation of the process.
Using CaliberBRM’s MBR, different process stages such as dispensing, blending, granulation, sifting, binder preparation, compression, mixing, coating, filling, sealing, and other stages in a product manufacturing cycle can be registered. This makes master configuration more efficient.
Equipment can be easily mapped to location using our configurable Master Batch Record. This exercise involves one-time effort. Later, during the master’s preparation and execution, the availability of equipment can be traced and mapped to location accordingly.
Bill of Materials (BOM) contains the complete information of quantities of raw materials, excipients and other materials used in batch production. The BOM changes as per batch size. Manufacturers can create BOM as per material type. The different material types they can deal with are drug substances (with formulae for potency, volatility, etc.), drug products (formulations, generic, excipients), packing, etc.
CaliberBRM tracks and reports the area and equipment’s operational and non-operational usage activities in different phases of production such as production, packing, cleaning, calibration, clearance, and covers preventive maintenance areas too. The system tracks area usage, equipment usage, checklist issuance, and execution.
In-process quality controls (IPQC) during different stages of production help ensure that complete batch production is going on smoothly. It is possible to carry out these checks with or without instrument connectivity. IPQX is performed by registering test protocols, sample withdrawal scheduling, test pattern, sample analysis as per workflow and acceptance criteria defined in the system. Automatic exception approval for the failed samples and test results trends can also be done.
CaliberBRM’s MBR helps in assigning roles and privileges to access the stage-wise tasks in execution review. Only the appropriate personnel will be able to securely access templates.