Batch Records 101: What You Need to Know
Manufacturing Batch Records are essential documents that provide a detailed account of the production process for a specific batch of a product.
Batch Records are critical documents for manufacturers and license holders, especially in regulated industries like Pharmaceuticals, MedTech, Food & Beverage, Supplements, and Cosmetics.
No matter if you are making vaccines, supplements, or the world’s best cookies, all manufacturers need to keep Batch Records.
But what are Batch Records and how are they used? Companies use batch records to do everything from ensuring product quality to defending potential litigation. Most companies use manufacturing records to:
Document the specific manufacturing process for a given batch or lot
Demonstrate consistent product quality
Show compliance to regulatory requirements
Create traceability to a specific batch or lot that was manufactured
When making GMP products that are regulated by a government body (like the U.S FDA, TGA, MFDS, PMDA, etc.), it is especially important to implement Good Manufacturing Practices (GMP) and document the manufacturing process as part of an official Manufacturing Batch Record. Batch Records are also a great way to demonstrate that the company has followed the applicable GMP regulatory requirements for their product.
What’s inside a batch record? At a high level, Batch Records serve as a comprehensive record of all steps taken, materials used, equipment utilized, and quality checks performed during production. These records also document who performed, reviewed, and approved different steps in the manufacturing process.
It is important to know that there isn’t a single standard Batch Record. Batch Records will vary by industry, product type, and even manufacturing facility. There are several different types of Batch Records commonly used in different industries to document the manufacturing and testing process that culminates in product release.
Let’s learn about several different types of Batch Records; for illustrative purposes, let’s pretend that we are a cookie manufacturer!
Master Batch Record (MBR): Think of the Master Batch Record like the official recipe. The Master Batch Record is the primary document containing detailed instructions for manufacturing a specific type of product (like the recipe for your favorite chocolate chip cookie!). It outlines the entire production process including raw material specifications, equipment usage, processing steps, critical parameters or setpoints, in-process controls, and quality assurance procedures. The Master Batch Record, or MBR, is a controlled document, where only the final, approved version is released to manufacturing for use in production. This record is used as a basis to create individual Batch Production Records (BPRs). It ensures consistency and uniformity across all batches of a product. After all, we want to make sure that the first cookie is as yummy as the last cookie!
Batch Production Record (BPR): Think of the Batch Production Record as the executed recipe for that particular batch of product. (How was this specific batch of cookies made on this particular day?) The Batch Production Record is created for each individual batch produced according to the specifications outlined in the Master Batch Record (MBR). The BPR documents the actual execution of the manufacturing process, including deviations from the MBR, along with any changes made during production. The BPR should be the accurate reflection of what was actually manufactured. The Batch Production Record should also be a controlled quality record.
Packaging Batch Record (PBR): This type of Batch Record specifically focuses on the packaging process. (After you made your cookies, how did you bag them, box them, and label them?) The Packaging Batch Record, or PBR, includes instructions for packaging materials, labeling requirements, packaging equipment setup, and any quality checks performed during packaging including the results of packaging line clearance checks. The PBR records the type of packaging materials and labeling that were used on a specific batch or lot of product. Any deviations or nonconformances should be documented in this record. These files are also historical records that demonstrate that all packaging & labeling requirements were met.
Cleaning Batch Record (CBR): Cleaning Batch Records detail the cleaning procedures followed between batches to prevent cross-contamination and ensure product quality and safety. (You switch from making chocolate chip cookies to making walnut cookies. It is important to clean the manufacturing equipment and workspaces.) The Cleaning Batch Record, or CBR, documents the cleaning agents used, the concentrations, contact times (if applicable), cleaning equipment, cleaning methods, and verification of cleanliness. As with any batch record, this is a quality record and should also include any deviations or nonconformances encountered during the process.
Analytical Batch Record (ABR): Analytical Batch Records are used in laboratories to record the results of tests performed on samples taken from a batch throughout the production process. (It’s important to check the density and sugar content of our cookies!) These ABRs document the testing methods that are used, the equipment ID & calibration, the test acceptance criteria, and the final test results. This laboratory testing may be used for in-process (intermediate) testing or to test the final product prior to release.
Validation Batch Record (VBR): Validation Batch Records are generated during the validation process to demonstrate that the manufacturing process consistently produces products that meet predetermined specifications. (You want to show that your cookie manufacturing process is validated and can consistently produce cookies that meet your specification using the settings and process you have defined.) The Validation Records typically include data from multiple batches produced under controlled conditions to validate the process. Validation Batch Records, orVBRs, are commonly used to perform the initial validation, for revalidating an existing process that has undergone significant changes, or for periodic revalidation per company procedure. Any changes to the planned production process or deviations from expected results should be documented within the VBR and investigated. This includes any deviations or nonconformances that may be encountered.
Equipment Logbooks: While not strictly Batch Records, Equipment Logbooks are often used to record equipment usage, maintenance activities, calibration checks, and any deviations or incidents related to equipment performance during production. These logbooks are considered quality records and should be formally issued, reviewed, and controlled. (In our illustration, we may have Equipment Logbooks for the dough mixer or the scale used to measure ingredients.) Logbooks can be actual physical books or they can be managed electronically through electronic quality management systems (eQMS) or manufacturing execution systems (MES).
Electronic Batch Record (EBR): Electronic Batch Records simply give manufacturers a way to document the Batch Record electronically. EBRs avoid the hassle of managing paper or scanned PDF documents, and most newer Electronic Batch Record Systems are cloud-based and allow for employees to share information, trend data, and communicate directly with their vendors. EBRs can integrate with other manufacturing systems, improve data integrity, reduce errors, and streamline the review and approval process. It is important for companies to balance the cost savings and efficiency of the EBR with the implementation and licensing costs.
Remember, It’s not enough to just create the Batch Record.
Batch Records need to be updated as things change in the manufacturing process. Batch Records also need to be formally reviewed by a Quality Reviewer, and the manufactured product needs a final disposition. When the product is manufactured, Batch Record documentation is complete, and all testing is finalized, the next step is to have the documentation packet reviewed by a skilled Quality Reviewer. It is important that a Quality Reviewer check the Batch Record before the product is released for use. (The quality representative reviews the chocolate chip cookie Batch Record before any of the cookies are shipped to customers.) Quality Reviewers check to make sure that specific batch was manufactured according to the predetermined requirements and meets all the product specifications. They also check to make sure the Batch Record is compliant with FDA or other applicable regulations.
After a quality review of the Batch Record is conducted, the product will receive a final disposition. Typically the product disposition is “Released,” “Not Released,” “Scrapped,” or “Needs Additional Information.” The Batch Record should reflect this final disposition.
In Summary, each type of Batch Record plays a crucial role in ensuring product quality, compliance with regulatory requirements, and traceability throughout the manufacturing process. Many people don’t consider the fact that maintaining accurate and reliable Batch Records is also important for Company Reputation, Legal Defense, and Traceability in case of a product recall. If you have questions about your Batch Records or need assistance with Batch Record Quality Review, please contact Team@BatchWize.com.
To learn more about the Value of Manufacturing Batch Records, check out this BatchWize blog.
About the Authors
Rebecca Waterbury has a background in MedTech, Pharmaceuticals, Biologics, IVD, Combination Products, and Food. She has an extensive background in Quality, Regulatory Compliance, Operations, Supply Chain, and Product Launch. Rebecca is a co-founder of BatchWize, a company specializing in the release of high quality products for clinical and commercial use. LinkedIn
Suthi Nagar is a Quality Reviewer with experience in herbal and organic products for cosmetic and medicinal use. She is a Senior Reviewer and co-founder at BatchWize. LinkedIn
BatchWize is a company focused on Manufacturing Record Review and Product Release for medical device, drug, biologic, food, cosmetic, and wellness companies. They work with companies around the globe to release quality products to the U.S. Market. BatchWize frees up quality personnel to work on mission critical projects, while saving their clients time and money. Schedule a call with our team.