A batch manufacturing record (BMR) is an important document for chemical and process manufacturers: It tells users how to produce a batch of a given product, then records the entire production process, from start to finish. The U.S. Food and Drug Administration (FDA) requires companies to create BMRs to ensure the quality and safety of food, drug and personal care products, so it’s crucial to complete them correctly.
However, these documents are also long and complex, with specific steps and guidelines that must be followed. Completing them by hand is tedious and time-consuming — but using specialized enterprise resource planning (ERP) software with electronic batch manufacturing records makes this process simple, streamlined and accurate.
In this post, we’ll show you how to prepare a batch manufacturing record, walk you through the benefits and features to look for in a new system and even provide a sample template to get you started. Here’s what we’ll cover:
What is a batch manufacturing record (BMR)?
A batch manufacturing record is a written record that documents the entire manufacturing process and the history of a product batch. In other words, it tells you how to produce a product and records the way that happens.
A batch is a specific quantity of a chemical, food, drug or other material that, according to the FDA, “has a uniform character and quality, within specific limits, produced according to a single manufacturing order during the same cycle of manufacture.”
BMRs are used in chemical and process manufacturing to ensure health, safety and quality while meeting FDA requirements. These regulations apply to companies that make consumable products or those that go on the body, including pharmaceuticals, packaged foods, nutritional supplements and personal care products such as deodorant and shampoo.
FDA regulators use BMRs to verify that health and safety procedures have been followed correctly; quality control testing has been performed; ingredients have been handled properly; employees have the proper clearance; and dual sign-offs have been completed when necessary.
But before creating the BMR, chemical and process manufacturers must create another document: the master formula record (MFR).
What is a master formula record (MFR)?
The MFR is a set of instructions that tells you how to produce a product batch, while the BMR records what you actually produced.
Think of this process like baking a cake: The MFR is your recipe, telling you how much flour to put in, how many eggs to add, how long to cook it for and at what temperature. The BMR is a record of how that cake turned out: the amount you made, how much batter was spilled along the way and how long it took to bake. And, of course, it documents the most important test for either a baker or a manufacturer: quality control.
What should be included in a master formula record?
The MFR outlines all the materials you’ll need to produce a product batch as well as step-by-step guidelines for how to create it. This includes:
- Bill of materials: The bill of materials includes all of the ingredients and components required at each step of the manufacturing process, along with their size, weight and measure.
- Health and safety information: This includes information on the proper handling of materials, such as heating, cooling and storage temperatures, as well as any personal protective equipment (PPE) that needs to be worn during the manufacturing process.
- Maintenance, cleaning and sanitizing instructions: If maintenance, cleaning and sanitizing needs to be performed prior to manufacture, instructions for when and how to do this must be included on the MFR.
- Step-by-step instructions of the manufacturing process: The MFR outlines detailed, clear and straightforward instructions for how to complete each step of the manufacturing process, from start to finish and in the proper order.
- Estimated costs and labor for each step: The MFR may include an estimate of the cost for completing each step. This is done by multiplying the cost of any equipment used by the labor hours required. For example, a mixer that costs $100 per hour and is run for 15 minutes would result in a cost of $25 for that step.
What should be included in a batch manufacturing record?
While the MFR provides instructions for manufacturing a standard size or percentage of material, the BMR documents the process of following these instructions. This involves scaling the MFR to produce the necessary quantities: For example, if the MFR includes instructions for producing 100 pounds, but you want to make 1,000 pounds, the BMR would scale all materials by 10.
Every batch manufacturing record must include all the information that pertains to producing the product batch, including:
- Start and end dates of the manufacturing process.
- All materials and components used, including the amounts of each one.
- Step-by-step documentation of the entire manufacturing process, from start to finish — including dates of completion for each step.
- Initials of the person performing and verifying each step, including dual sign-offs where required.
- Health and safety information for each step of the manufacturing process, including any potential hazards and personal protective equipment (PPE) required.
- Lists of equipment and processing lines used.
- Results of quality control tests and status checks, including deviations from the process and any byproducts or co-products.
- Maintenance and cleaning information for equipment and processing lines, including the date and time completed, health and safety information and any PPE required.
- Actual and expected batch yields at each step.
- Packaging and labeling requirements and documentation.
- Bill of materials and bill number.
- Definitions of any abbreviations used.
- Complete change log and audit trail.
- The batch, lot or control numbers for each lot that is packaged, labeled and/or distributed from the finished product.
- Documentation proving the finished product meets established specifications.
Benefits of batch manufacturing records software
BMRs are long, complex documents. Completing them by hand or using manual methods such as spreadsheets is time-consuming, tedious and prone to human error. This also puts your company at risk of regulatory violations, which can result in costly fines. Using BMR software to create electronic batch records vastly simplifies this process — saving time, increasing accuracy and ensuring compliance while streamlining production cycles.
It’s also important that BMRs integrate with the rest of your company’s data, so inventory, sales, accounting, marketing and other key business functions are synchronized across the organization. Choosing an ERP system with batch manufacturing records functionality ensures all company data stays up-to-date while improving operations.
Here are just a few of the benefits of using specialized ERP software with batch manufacturing records functionality:
- Streamlined production workflow. By creating a bill of materials before completing the BMR, you can plan and stage materials ahead of time, ensuring a more efficient production workflow. The software also provides workflows for streamlined routing, review and approval of batch manufacturing records.
- Company-wide integration. Choosing an ERP system with BMR tools integrates and streamlines operations across departments, while making data easily accessible to the entire company.
- Improved efficiency. No more writing entries by hand, searching for documents or double-entering data. Electronic BMR software vastly improves efficiency by automating key processes, such as data entry, calculations, conversions, document retrieval and equipment readings.
- Increased accuracy and reduced waste. Automatic calculations, unit-of-measure conversions, equipment integrations and inventory adjustments increase accuracy by decreasing the risk of human error. Quality control tracking ensures recipes are properly followed and notes any deviations from the process, boosting product quality and reducing waste.
- Real-time updates. Integrated ERP systems with BMR software instantly reflect changes to MFRs, BMRs, formulas, inventory and more, so everyone in your organization always has the most current information.
- Data-backed decision-making. View batch production schedules and track quality control testing for full visibility into the manufacturing process, enabling you to make more informed decisions.
- Optimized reporting. Built-in reporting and analytics capabilities streamline batch reporting and ensure the accuracy of your results.
- Regulatory compliance. BMR software automates key aspects of compliance, such as collecting, organizing and reporting information to regulatory agencies. This helps your company avoid fines and penalties while keeping workers and consumers safe.
To learn more about the features and benefits of an integrated ERP system, check out our guide.
How to choose the right BMR software
Most BMR software is designed for discrete manufacturing, in which products such as phones or cars are assembled from parts according to a relatively simple bill of materials. These systems don’t have the functionality to handle the complex recipes, formulas and calculations that chemical and process manufacturing requires, or calculate and track the loss factors, byproducts and co-products that come along with it.
When choosing BMR software, look for a vendor with a history of serving the chemical and process manufacturing industry and offering features tailored to your market’s unique needs. Datacor, for example, has 35 years of industry expertise, and designed its ERP system specifically for chemical and process manufacturing companies.
The following features are also important for preparing batch manufacturing records in the chemical and process manufacturing industry:
Step-by-step instructions and authentications. BMR software makes a copy of the master formula record, auto-populating instructions so users are guided through the manufacturing process step by step without leaving the software interface. The system also logs sign-offs and permissions for steps that require double authentication.
Industry-specific compliance management. ERP systems with BMR software come with industry-specific tools for compliance management, automatically collecting and organizing the necessary information and documentation to meet FDA requirements. Health and safety hazards and required PPE are included at each step, and automatic software updates keep compliance information up-to-date.
Security and audit controls. Certain steps of the manufacturing process, as well as the ability to make changes to MFRs and BMRs, may be restricted to specific workers. In some cases, a second person may need to sign off on safety precautions; cleaning and sanitizing procedures; calculations; and material identifications. Security and audit controls, such as role-based permissions and double authentication, ensure that only the right people have access at the right times.
BMR software specialized for the chemical and process manufacturing industry also provides a complete audit trail and tamper-proof records for FDA compliance, automatically logging and timestamping changes along with the associated user ID.
Inventory management. By integrating with inventory and warehouse management modules, ERP systems with specialized batch manufacturing records functionality update material usage as the record is completed, enabling real-time inventory counts through instant quantities and yields.
Mobile BMRs. With mobile device capabilities, you can access batch manufacturing records from anywhere; eliminate hard copies; record formula changes instantly; and check inventory while on the go.
Quality management. Producing a quality product is essential for keeping customers happy, upholding your reputation and meeting regulatory requirements. Quality control features help users manage quality testing data; track deviations from the MFR; identify and investigate the source of any variances; and manage byproducts and co-products.
Equipment integration. Some specialized BMR systems integrate directly with chemical and process manufacturing equipment, such as scales, thermometers and pressure sensors. That means weight, temperature, pressure and other readings are automatically calculated and entered in the MFR or BMR, instead of requiring users to manually enter them in the system. This saves time and effort while vastly increasing accuracy.
Unit of measure conversions. Batch manufacturing records software specialized for the chemical and process manufacturing industry will automatically convert units of measure and packaging into the base units you need to measure your inventory. This ensures accurate quantities, prices, and sales and analytics information, while helping you manage recipes and formulas.
Dynamic fields and scaling. Connect data recorded in previous steps to the current step, and perform calculations and comparisons across steps with dynamic fields. Meanwhile, the scale up and down feature automatically changes the MFR when you need to update product yields.
Master packaging records and batch packaging records. Specialized instructions and records are required for products such as pharmaceuticals that involve taking a large amount of bulk finished good and packaging it into another form, such as tablets, pills or capsules.
BMR software for the chemical industry comes with specialized functionality for creating master packaging records (MPR) and batch packaging records (BPR) — the equivalent of MFRs and BMRs for packaged batches. Since packaging is an additional step after manufacturing the raw material, these documents are used after the MFR and BMR, outlining instructions for packaging — for example, how much raw material to press into a tablet, how many tablets go into a bottle and what kind of cap to use — and documenting the results.
Datacor is developing a Manufacturing Execution System (MES), and is launching Batch Production as its first iteration, eliminating the manual process of creating a batch manufacturing record all together. See what else is in the pipeline for 2022 here.
Batch manufacturing record template
To access all of the features and benefits outlined here, you’ll need to use an integrated ERP system with BMR functionality, such as Datacor ERP. In the meantime, we’ve included a sample of what this might look like. Note that this is only an example — your organization will need to customize its batch manufacturing records according to your unique requirements.
To learn how Datacor ERP can help your company simplify and streamline batch manufacturing records while increasing product quality, sign up for a personalized demo today.