Simplified creation and management of MBRs

PAS-X MBR solution

Does your company’s manufacturing process involve a huge number of records or perhaps highly-complex master batch records? With PAS-X Master Batch Records, your efforts and costs will be reduced while quality is enhanced. Our solution replaces paper-based MBRs with database-supported, electronic documents. MBRs 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.

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Shawn Opatka

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Structured management

Master Batch Records (MBRs) are general manufacturing instructions. Batch Records are derived from them and refer to a specific order. Master batch records and batch records are therefore the basis for a precise and detailed description of pharmaceutical manufacturing processes. They contain all pharmaceutically relevant data: the input material list, valid SOPs, detailed work instructions to be applied in production, and also process data, or process steps, such as in-process controls (IPCs), Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

Even today, conventional word processing systems are often used to create and maintain master batch records and batch records. The final result is paper documentation. It really is an uphill struggle: Time-consuming and error-prone manual reconciliation or approval procedures are required to carry out tasks like structuring, maintaining and managing versions of master batch records for reconciling data with the ERP system.

Master Batch Records by contrast, is based on structured master batch records which are subject to automatic version management and which use libraries with reusable building blocks. The use of standardized building blocks makes it much easier for the user to create and maintain master batch records.

In particular, PAS-X also administers those recipe elements which are specific to interfaced process control systems (DCS/SCADA). An integration layer that is independent from the actual control system enables the general definition of recipes, which are then implemented in a way suiting the specific control system used.

MBR designer

MBRs structured by means of predefined building blocks

Master Batch Records maps master batch records as graphical structures:

Master Batch Records allows the user to set up libraries with standardized, reusable building blocks which can then be used to create a master batch record. These building blocks are subject to version management. Master batch records are defined and displayed using a graphical design tool.

The applied master batch record structure meets the requirements of the ANSI/ISA 88 / 95 standards.

Parameterization of unit procedures for automation and PCS systems

In fully automated production environments, the standardization of production recipes is moved to level 3 of the S95 model.

Thus, the MES becomes the leading system for the definition of recipes while these are actually executed at the level of the process control system. The relevant data tags can be managed as logical or physical tags.

Intelligent business function

When master batch records are created, the Master Batch Records business function carries out defined checks to ensure plausibility and completeness.

For this purpose, it is possible to set the parameters for more than 50 different test criteria. For instance, it can be checked whether the recipe specifies the required target values for the process. If specifications are missing at any point, the system will display a message to the user.

Master Batch Records calculates material quantities across entire MBRs and lists totals of all input material quantities in BOMs. Yield calculations are also taken into account, as they permit the drawing up of the requested "material balance sheets".

Electronic approval workflows

Master Batch Records supports all workflow necessary for review and approval. The system will notify all relevant personnel by e-mail and then deliver the required documents in electronic form directly to the user's desk. Any corrections and changes to the master batch records are made and documented within the system itself. Electronic signatures are used to sign approvals in compliance with 21 CFR Part 11.

Master Batch Records facilitates and simplifies workflows, shortening approval cycles and therefore drastically reducing associated documentation work.

Integration with ERP systems

Master Batch Records provides standard interfaces to all leading ERP systems. By means of configuration, Master Batch Records can be adjusted to the requirements for different ERP systems. Depending on the specific ERP system, the contents will be simple bills of material or routing structures. When generating orders, Master Batch Records will fill in missing information and maintain it in FDA/GMP-compliant manner.

This business function thus offers an essential benefit in the context of software system validation: Master Batch Records business function includes all software functions which are subject to validation and can therefore be validated as 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 would be costly and time-consuming.

PAS-X standard interfaces