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PAS-X Business Functions
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| MASTER BATCH RECORDS |
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| Structured Management of Master Batch Records |
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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
(DCS/SCADA) systems. 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.
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| Building-block-based Structure of the Master Batch Records |
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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.
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| Parameterization of Unit Procedures for Automation and Process Control Systems |
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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.
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| MASTER BATCH RECORDS is an intelligent Business Function |
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When master batch records are created, MASTER BATCH RECORDS carries out checks
on 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 if the recipe specifies the required process set values. If
specifications are missing at any point, the system will display a message to the user.
MASTER BATCH RECORDS calculates material balances across entire MBRs and lists totals of all
input material quantities in BOMs. Yield calculations, which permit the drawing up 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 Approval Workflows |
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MASTER BATCH RECORDS
supports all workflows necessary for review and approval. 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 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.
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| Integration with ERP Systems |
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MASTER BATCH RECORDS
provides standard interfaces to all leading ERP systems.
MASTER BATCH RECORDS can be adjusted to various ERP systems
by using system configuration features. Depending on the specific
ERP system, the contents will be simple bills of material or basic
recipe structures. When generating orders, MASTER BATCH RECORDS will
fill in missing information and maintain it in FDA/GMP-compliant
manner.
This business function thus provides an essential benefit: MASTER BATCH RECORDS includes all
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.
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