Oracle Manufacturing Execution System (MES) for Process Manufacturing provides comprehensive electronic Master Batch Record (MBR) and Control Batch Record (CBR) documents that contain critical batch information from the product recipe and each production batch respectively.
This chapter covers the following topics:
Following is a requirement that customers have for supporting electronic batch records:
Paper batch records are replaced by an electronic procedure management and recordkeeping system. The application provides a complete solution with electronic signatures and audit trails. The Electronic Batch Record (EBR) that defined by the US FDA, includes text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. The Oracle Manufacturing Execution System (MES) for Process Manufacturing application lets you store all batch-relevant data in the database for rapid retrieval and processing.
Use the Master Batch Record and Control Batch Record for Paperless Recordkeeping
The master production record is often referred to as the master batch record. This is the documented and approved set of instructions used to describe how to manufacture a specific product. The required elements of the master batch record are outlined in CFR Title 21 Part 211.186.
The OPM master batch record consists of the recipe, which includes the material requirements, equipment, resource requirements, processing instructions, sampling requirements and various notes regarding batch processing. It is the template that is used repeatedly to manufacture a consistent product.
The OPM control batch record is a journal that documents all events in the batch lifecycle. The control batch record aligns to the specifications of CFR Title 21 Part 211.188.
The U.S. Food and Drug Administration (FDA) provides guidelines for master production and control recordkeeping that meet current good manufacturing practice for finished pharmaceuticals:
Master Batch Record (MBR) Section 211.186, Code of Federal Regulations (CFR) of the US Food and Drug Administration (FDA)
Control Batch Record Section 211.188, Code of Federal Regulations (CFR) of the US Food and Drug Administration (FDA)
The intent of these records is to assure product uniformity from batch to batch. The master production and control records for each product include written procedures for batch formulation that must be followed on the shop floor, and a complete batch control record to document that each significant step in the manufacture, processing, packing, or holding of the batch is done. These records must be signed and dated by at least one individual, and independently checked, dated, and signed by a second person. Oracle Manufacturing Execution System (MES) for Process Manufacturing uses Oracle E-Records to provide a comprehensive, paperless method to comply with Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures.
The Master Batch Record (MBR) provides detailed recipe-specific information. It is a complete specification for manufacturing a specific batch size in a specific plant at a specific time. The MBR must provide:
Name and strength of the product with its description
Name and weight or measure of each active ingredient
Complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristics
Accurate statements of the weight or measure of each component, using the same weight system
Statement concerning any calculated component excesses
Statement of theoretical weight or measure at appropriate phases of production processing
Statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which an investigation is required
Description of product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the individuals responsible for label approval
Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed
The MBR contains all the key information in the product recipe, including a complete specification to manufacture the product in a given plant, batch size, and date range. The MBR contains the recipe header information, validity rule data, formula details, routing details, instructions, and material dispensing setup information with the corresponding instructions. It is available for viewing and printing after the recipe validity rule is approved for general use.
Batch control records provide a complete information set related to the production and control of each individual batch. The Control Batch Record (CBR) is updated with actual data as the batch proceeds through its lifecycle. Material usage, dispensing activities, and component weights and measure records provide batch traceability. Product output quantities, lot details, manufacturing nonconformances, and quality sampling and test results all add to this batch history. The CBR must provide:
An accurate reproduction of the appropriate MBR checked for accuracy, dated, and signed
Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:
Start date, stop date, and time stamps for each step
Identity of specific major equipment and production lines used
Identification of each batch of component or in-process material used
Weights and measures of components used in processing
In-process and laboratory control results
Inspection of the packaging and labeling area before and after use
Statement of the actual product yield
Statement of the percentage of theoretical yield appropriate phases of batch processing
Complete labeling control records, including specimens or copies of all labeling used
Description of product containers and closure systems
Quality sampling performed
Identification of the individuals who performed each task
Identification of individuals who supervised or checked each significant step in the operation
Documentation of any investigations for nonconformance
Results of examinations made for compliance
The electronic CBR is created when the production batch is created. It is updated with actual data as the batch progresses though its life cycle. The CBR contains information such as actual material usages, product output quantities and lot details, manufacturing nonconformance, quality samples and results, label images, instructions, material dispensing setup information with the corresponding instructions, changes in batch and batch step status, operator comments, and all electronic signatures captured during the processing of the batch. Configure the system to obtain e-signature approvals before closing a batch.
The final stage of the production batch lifecycle is to close the batch. Oracle Manufacturing Execution System (MES) for Process Manufacturing documents this transaction with e-signature approvals. The final CBR is secured in the e-records repository, where authorized responsibilities can view or print it.
Title III of the US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (also known as the "Bioterrorism Act") is "Protecting Safety and Security of Food and Drug Supplies." Title III requirements include "... the need to establish and maintain records by those who manufacture, process, pack, transport, distribute, receive, hold, or import food, as may be necessary to trace the source and the chain of distribution of food, its components and ingredients, and its packing in order to address threats of serious adverse health consequences or death to humans or animals.” Oracle Manufacturing Execution System (MES) for Process Manufacturing provides fully traceable recordkeeping that can be used to meet the requirements of this act. Coupled with other Oracle Process Manufacturing (OPM) applications such as Quality Management and Process Execution, build Hazard Analysis Critical Control Points (HACCPs) throughout the manufacturing supply chain. Oracle Manufacturing Execution System (MES) for Process Manufacturing helps meet the requirements for this important requirement for food and drug safety.
The CBR captures the major events of the batch including dates of the event and name of the person who made the transaction for:
New Material Added
Material Removed
Step Added
Step Removed
Additional Resource Requirements
Deletion of Resource
Activity Added
Activity Update
Resource Details Updated
Batch Update (Header)
Batch Step Update
Process Parameter
Oracle Manufacturing Execution System (MES) for Process Manufacturing modifies the output of several events, including:
Batch Release
Material Allocation
Step Release
Step Reopen
Batch Reopen
Step Complete
Step Close
Batch Complete
Batch Close
Batch Termination
Revert to Work in Process
View and print the Master Batch Record (MBR) from Recipe and Recipe Validity Rules windows. The Master Batch Record (MBR) consists the recipe hierarchy:
Recipe Summary Information such as Recipe and Recipe Validity Rule
Material Requirements such as Formula
Sample
Instructions with Standard Operating Procedure (SOP) Reference
Dispensing Setup
Detailed Routing Information, that is, Routing Steps
Instructions with SOP Reference
Activities
Resource Requirements and Instructions with SOP Reference
Refer to "Recipes" in the Oracle Process Manufacturing Product Development User’s Guide for detailed information on recipes and recipe validity rules.:
To view and print the MBR from a recipe
Create or query a recipe. Enter as many parameters as needed to complete the search:
Select Recipe, Description, Formula, Routing, or Product with appropriate Version for Recipe, Formula, or Routing. Select Organization, Customer, From Date, To Date, Status, and Recipe Use.
Select View Master Batch Record from Actions.
Print the draft version of Master Batch Record.
To view and print the MBR from the recipe validity rule
Create or query a recipe. Enter as many parameters as needed to complete the search.
Select View Master Batch Record from Actions.
Print the Master Batch Record.
View current production status for multiple batches at a time. Navigate to the Production Status window from the MES for Process Manufacturing Administrator responsibility.
View detail batch progression details for a specific production batch.
Navigate to the Production Status window.
Create or query batches. Enter as many parameters as needed to complete the search.
Select Organization, Batch, Product, Status, From Date, and To Date.
Click a batch number.
View current production status for multiple batches at a time and also view detail batch progression details for a specific production batch.
To view and print the Control Batch Record
Navigate to the Batch Progression window.
Click View Control Batch Record.
View or print the CBR from the Batch Details window using the Operator Workbench.
Control Batch Record (CBR) consists of:
Material Details
Instructions
Samples
Nonconformance
Dispensing
Material Transactions
Routing Steps with Overrides
Instructions
Nonconformance
Operations
Nonconformance
Instructions
Activities
Nonconformance
Instructions
Resource Requirements
Instructions
Process Parameters
Resource Transactions