The PAS-MBR Start-up Package is particularly suited to companies that describe their manufacturing processes with complex or a huge number of master batch records or MBR variants. With PAS-MBR, effort and cost is reduced while quality is enhanced.
PAS-MBR replaces paper-based master batch records with database-supported, electronic documents. Master batch records can be conveniently created on screen, and documents are managed by using paperless electronic workflows. Role-based processes are applied to control the electronic workflow for approval, and this ensures safe version management of your manufacturing documents. The electronically created master batch records can also be linked to order data. Batch records destined for production are then printed out on paper for further execution.
GMP-compliant descriptions of pharmaceutical production processes are based on general master batch records and derived, order-related batch records. They contain all pharmaceutically relevant data: the input material list, valid SOPs, detailed work instructions to be applied in production, process data, or process steps such as in-process controls, Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Even today, conventional word processing systems are frequently used to create and maintain master batch records. The final result is paper documentation. It really is an uphill task. Time-consuming and error-prone reconciliation and approval workflows are required to manually carry out the tasks like structuring, maintaining, and managing versions of master batch records or reconciling data with the ERP system.
By contrast, electronic master batch record management with PAS-MBR, is based on structured master batch records which are subject to automatic version management and which use libraries with reusable building blocks. The application of standardized building blocks makes it much easier for the user to create and maintain master batch records.
Parametric master batch records make it possible to create product groups that are subject to similar production procedures, but involve a number of different parameters, e.g., packing with different packing material and including different patient information leaflets.
The use of easy-to-maintain parameter lists results in shorter release times. In view of frequently changing product requirements, effective release times are a major issue in pharmaceutical marketing. In particular for complex packaging procedures, this functionality is most beneficial.
Using PAS-MBR, the user creates the required order-related manufacturing documents on the basis of orders entered in the ERP system, and then prints them for use in production. This ensures that only approved master batch records and SOPs are used.
Due to its modular structure, the PAS-MBR Start-up Package can be gradually upgraded to a functionally complete PAS-X Manufacturing Execution System. In conjunction with the PAS-X functions
WEIGHING & DISPENSING
and ELECTRONIC BATCH RECORDING , even
a complete electronic batch documentation can be achieved. With a PAS-MBR Start-up Package as first step for an incremental
MES deployment, you have a strong basis for a safe investment.
In the context of master batch record creation, PAS-MBR allows the user to create libraries using standardized, reusable building blocks. These building blocks are subject to version management.
Drag and drop functionality enables users to graphically build and design their master batch records.
The MBR structure used in PAS-X meets the requirements of the ANSI/ISA 88 / 95 standards.
Users may also model recipes for product groups. In this context, the use of parameter-based recipes minimizes the effort involved in maintaining MBRs.
When a master batch record is created, PAS-MBR carries out checks on plausibility and completeness.
It is possible to set the parameters for more than 50 different test criteria, for example, to check whether the recipe contains the set values required for the process. If any specifications are missing, the system will display a message to the user.
PAS-MBR balances accounts across entire MBRs and lists the totals of all input material quantities in a BOM. The system also accounts for yield calculations,
enabling proper account balancing and appropriate control of the entire manufacturing process.
PAS-MBR supports all workflows necessary for review and approval. For example, the system will notify all reviewers by e-mail and then deliver the required documents in electronic form directly to the relevant user's desk. Any corrections and changes to master batch records are made and documented directly in the system. Electronic signatures, which comply with 21 CFR Part 11, are used to sign approvals. PAS-MBR facilitates and simplifies workflows shortening approval cycles, and therefore drastically reducing associated documentation work.
PAS-MBR uses the order information from the ERP system to create batch records based on the respective master batch records. Batch records contain all the information relevant to the manufacture of a pharmaceutical product. It is these records that the pharmaceutical worker uses to document all issues involved in the production process. Among other things, PAS-MBR calculates production quantities and determines the BOM items required for the input material according to exact recipe specifications.
PAS-MBR includes standardized interfaces to any major ERP system and can therefore be easily integrated into existing IT system landscapes. By means of system configuration, PAS-MBR can be adjusted to various ERP systems. Depending on the ERP system, the contents will be simple bills of material or basic recipe structures. When generating orders, PAS-MBR will fill in missing information and maintain it in an FDA/GMP-compliant form.
This function thus provides an essential benefit: PAS-MBR combines all functions required for validation and can therefore be used as a master system for the creation of master batch records. It is no longer necessary to carry out additional validation for the higher-level ERP system, which is costly and time-consuming.
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Replace paper documentation
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