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PAS-X Start-up Packages
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Start-up Package for a Structured Management
of Master Batch Records
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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.
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| Electronic application to replace paper documentation |
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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 the 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.
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.
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| Expandability through Incremental Deployment |
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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.
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| Modular Structure of Master Batch Records |
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PAS-MBR maps master batch records as graphical structures:
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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. Master batch records
are structured and presented in graphical form.
The master batch record structure used in PAS-X meets the requirements of the
ANSI/ISA 88 / 95 standards.
It is possible to model recipesRecipes can also be modelled for product groups.
Master batch record maintenance can be minimized, since PAS-X uses Wparametrical
recipes and facilitates parameter settings.
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| PAS-MBR, an Intelligent System for the Creation of Master Batch Records |
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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 calculates material balances across entire MBRs and lists totals of all input material
quantities in BOMs. Yield calculations, which permit the drawing of material balances and consequently
the control of the entire manufacturing process, are also taken into account by the system.
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| Electronic MBR Approval Workflows |
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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.
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| Generation of Batch Records |
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Orders submitted from the ERP system initiate PAS-MBR to create Batch Records from Master
Batch Records. Batch records contain all relevant information for the manufacture of a pharmaceutical
product, and they create the basis for documentation during the production process. In this respect
PAS-MBR is responsible, among others, for calculating production quantities and input-material BOM
items exact to the recipe.
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| Integration into ERP Systems |
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PAS-MBR includes standard interfaces to any major ERP system and can therefore be
easily integrated into existing IT system landscapes.
By use of system configuration, PAS-MBR can adjust 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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