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MPR stands for Master Production Record. It is an approved master template containing the instructions, formulation, material list, equipment information, production steps, quality-control points, and acceptance criteria required to manufacture a product consistently in a GMP environment.
MPR is often used for a similar purpose to MBR, or Master Batch Record. Both types of records define how the production process is carried out. However, terminology may vary depending on the regulatory region, company procedures, and product type. In Electronic Batch Record (EBR) systems, master record templates such as MPR or MBR are digitized and converted into an eMBR structure, and an EBR record is created for each actual production batch. Centra's Electronic Batch Record (EBR) solution supports the management of these master record structures in a more controlled and traceable way in a digital environment.
The Basic Structure of the MPR Concept
What is MPR?
MPR is the master production record used in the manufacturing of a product. This record defines which raw materials will be used, in what quantities, with what equipment, and through which process steps the product will be manufactured. It also includes the controls to be performed during production, the record fields to be filled in, the acceptance criteria, and the approval points.
Why is MPR considered the master record?
Because the MPR is the reference document used as the basis for preparing each production batch. The production team works according to this template, and the quality team evaluates whether the actual batch record is being kept in accordance with this template.
What information does the MPR include?
An MPR document may include fields for product name, product code, batch size, raw material and auxiliary material list, material quantities, production equipment, process steps, production instructions, critical process parameters, IPC controls, quality control tests, yield calculations, and signature.
Why should MPR content be standardized?
A standard structure ensures production consistency across different batches. If each batch is executed in a different format or with different instructions, the risk to quality increases. MPR ensures that production is repeated using the same approved method.
What is the difference between MPR and MBR?
MPR and MBR are often used for similar purposes. MPR stands for "Master Production Record," while MBR stands for "Master Batch Record." Both define the production instructions for a product. In some companies, MPR may be used to refer to a broader production record, while MBR may refer to a master batch template used for a specific batch size and product version.
Brief summary of the difference.
MPR can be thought of as the main instruction set of the production process. MBR, on the other hand, is the implementation of this instruction as a batch-based production template. However, in practice, these two concepts are often used interchangeably or with very similar meanings in many businesses.
What is the difference between MPR and BPR?
MPR is the master template; BPR, or Batch Production Record, is the actual record filled out during the production of a specific batch. While MPR answers the question "how will it be produced?", BPR records "how this batch was produced?". Therefore, MPR can be considered the blank and approved master document, while BPR is the completed record created during production.
Where does EBR fit into this relationship?
EBR is an electronic and more controlled version of BPR. This means that the actual production record, derived from the MPR or MBR template, is digitally created in the EBR system and filled in live during production.
What is the relationship between MPR and BMR?
BMR stands for "Batch Manufacturing Record" and is a record that shows the manufacturing process of a specific batch. In some companies, BMR covers only the production or manufacturing part, excluding packaging processes. MPR, on the other hand, is the master production pattern that forms the basis for creating these production records.
Are BMR and BPR the same thing?
In some businesses, they may be used interchangeably. However, in some quality systems, BMR refers to the production phase, while BPR refers to the broader batch production record, including production and packaging. This distinction must be clearly defined in company procedures.
Frequently Asked Questions about MPR, EBR, and Digital Production Records
How is MPR transferred to an electronic format?
When transferring MPR to an electronic format, the existing document is first analyzed. Production steps, data fields, material validations, critical limits, electronic signature points, quality control steps, and deviation triggers are determined. Then, this structure can be defined in the EBR system as an eMBR template.
Should MPR be converted directly to digital format?
Generally, no. The long texts, repetitive information, and manual control areas in paper MPRs must be redesigned in a digital system. Digitalization means more than just transferring paper to a screen; it means making the process more controlled.
Why is MPR version control important?
MPR version control ensures that production is carried out only according to approved and up-to-date instructions. Producing with an outdated version can pose serious risks to product quality and GMP compliance. Therefore, MPR changes should be managed in a controlled manner, and it should be monitored which version is used in which batch.
How can electronic systems strengthen version control?
In the EBR system, only active and approved eMBR/MPR versions are allowed to create new batch registrations. Older versions are archived but their association with past batches is preserved.
How should MPR changes be managed?
Changes to the MPR should be managed through a change control process. If the formulation, process parameter, equipment, quality control point, acceptance criterion, or production step changes, an impact analysis should be performed, necessary approvals obtained, and validation assessment conducted if required.
Do all MPR changes carry the same risk?
No. While correcting a typo might be low-risk, changing a critical process temperature or removing a quality control point is a high-risk change. Therefore, changes should be evaluated on a risk-based approach.
How is MPR reviewed during audits?
Auditors can examine whether the MPR is approved, up-to-date, version-controlled, and consistent with actual production records. They can also inquire whether the critical steps outlined in the MPR were actually implemented during production, whether signatures were completed, and whether deviations were properly managed.
What is the most important point in auditing?
The most important point is the consistency between the master production record and the actual batch record. The instructions defined in the MPR must be implemented in the field, and records of their implementation must be complete and traceable.
How does Centra EBR support MPR management?
Centra EBR can support the conversion of the MPR structure into electronic templates, recipe and version management, digitization of production steps, identification of electronic signature points, and the creation of actual batch records from these templates. Thus, the MPR transforms from a static document into a digital structure that guides production.
What should businesses do to start the MPR digitalization process?
Businesses should first review their existing MPR/MBR documents, determine which products or operations will be digitized on a pilot basis, and identify critical data areas. To evaluate the transition from MPR to eMBR and EBR structures, you can contact Centra via their information page.
