Master Production Records (MPR) give the planning department a starting point for determining the materials required for inventory, while Batch Production Records (BPR) consume the inventory during manufacturing. Cutting-edge businesses often store these documents in an Electronic Documentation Management System (EDMS). However, all cGMP manufacturers are required to have separate Master Production Records and Batch Production Records to comply with FDA requirements.
To understand how MPRs and BPRs affect inventory, it helps to have a thorough understanding of the differences between MPRs and BPRs and to understand the purpose of each.
What Are Master Production Records?
Master Production Records, also known as Master Manufacturing Records, Master Manufacturing Formula, or Master Batch Records, are a set of general manufacturing instructions. Each unique formulation and batch size of a product is required to have its own MPR. Per the FDA, MPRs must include:
- Identification of product name.
- Bill of materials detailing weight and measure (count) of each component needed to manufacture the batch.
- Equipment list.
- Component list.
- Statement of theoretical yield.
- Expected yield of the finished product.
- Specific instructions for each step of the manufacturing process.
- Sampling and testing procedures.
- Instructions for manual operations.
The MPR’s purpose is to lay out all the process requirements needed to make the product – from raw materials to equipment – and ensure that each step in the process is completed. It also provides a guarantee of uniformity from batch to batch for each batch size and unique formulation of product manufactured.
For inventory management purposes, the MPR acts like a master list for determining materials and quantities needed in inventory to produce the finished product. Consider a dietary supplement manufacturer with a new 30-count bottle of chewable vitamin C tablets. Before the new product can be manufactured, the planning department must know what materials and how much are needed.
Because the MPR lists each material needed, the planning department can use it to determine materials and quantities. Packaging materials must also be purchased, so a quick glance at the MPR details the bottles, caps, cartons, cases, and labels needed.
The ingredient list in the MPR becomes a bill of materials that ensure the purity, strength, and composition of the finished product. Knowing what materials are needed, the purchasing department can source them and ensure sufficient stock is in inventory.
What Are Batch Production Records?
The Master Batch Record is used as a template to create Batch Production Records for the manufacturing process. Every batch of product must be documented in a Batch Production Record to show that it was created in accordance with the MPR and explain any deviations that may have occurred.
Per the FDA, BPRs must include:
- Batch number.
- Identity of equipment and processing lines used in producing the batch.
- Equipment maintenance, cleaning, and sanitization records for the processing line.
- Inventory codes for all components and raw materials.
- Identity and weight of each component used.
- Actual yield and theoretical yield.
- Any monitoring or testing results and their compliance with specifications, as well as documentation at the time of performance of the processing steps, and batch record review by quality control.
The BPR’s purpose is to record when, how, by whom, with what tools, and in what environment a specific batch of product was produced. The BPR is where operators record the lot numbers and the exact weights of raw materials used, specific equipment numbers utilized to produce the batch, and the count of components used in that specific batch.
For inventory management purposes, BPRs are how inventory is consumed. Going back to the dietary supplement example, every manufactured batch of the new 30-count chewable vitamin C tablet will be documented in a BPR. This BPR provides a way for the manufacturer to have a controlled record of the process, which traces finished products to specific raw materials and components.
Any time the new product is made, inventory management will subtract materials used per the BPR. If the BPR documented 20.052 kg of citric acid was used, that exact amount must be subtracted from inventory.
Electronic Batch Record Systems
In the modern manufacturing environment, an Electronic Batch Record system (EBR), such as InstantGMP™ PRO, is a logical choice to interconnect MPRs, BPRs, and Inventory Management Systems. Instead of the cumbersome paper systems of the past, electronic systems now allow operators in any production area to view and manage BPRs in real time, while automatically checking and updating inventory levels with production.
An EBR like InstantGMP™ PRO can also provide the controls a cGMP inventory management system needs to ensure only in-spec, released materials are used in production. With a scan and a click, operators track raw material barcodes to quickly subtract materials used in production.
When materials reach minimum reorder levels, An EBR such as InstantGMP™ PRO will automatically issue reorder reports with the recommended replacement amounts already calculated.
While the names and acronyms are similar, MPRs and BPRs are two different keys to comprehensive accountability of your inventory. From defining inventory needs through the Master Production Records, to using the inventory on hand with Batch Production Records, these documents affect inventory in separate, but important ways.
If you’d like to learn more about how InstantGMP™ PRO can help you better utilize your inventory with electronic Master Production Records and Batch Production Records, contact us for a live demonstration.