Master Batch Record: A Guide to Pharma Compliance Records

Manufacturers in the life sciences industry are under strict supervision by various regulators and governing bodies to ensure the drugs and medicines they produce are safe and effective for the end consumer.

To ensure that manufacturers abide by necessary regulations and their products meet the proper health and safety standards, businesses are required to document every aspect of their operations including the materials used, the personnel involved in production, and the processes that the product went through.

For example, manufacturers under the jurisdiction of the U.S. Food and Drug Administration (FDA) are required to create documentation for each drug formulation and batch they produce.

This documentation allows both internal quality management teams as well as external regulators to ensure that production processes were carried out in accordance with the manufacturer’s plan.

One of the crucial documents that guide pharmaceutical manufacturers’ efforts is the master batch record.

Historically, master batch records have been documented using pen and paper, but within the past decade, more and more manufacturers have invested in digital solutions to help centralize necessary documentation and streamline their compliance records.

In this post, we’ll review the importance of the master batch record and why more pharmaceutical manufacturers are turning to digital solutions to help improve the way they manage their compliance records.

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A master batch record (MBR), also known as a master production record (MPR) is a document that contains the approved ingredients, formulation, and instructions guiding the production of a pharmaceutical product. The document enables manufacturers to follow the necessary regulatory guidelines when manufacturing a product.

Because the master batch record governs the entirety of a pharma product’s manufacturing process, it takes on several other names. It is sometimes referred to as a manufacturing batch record, master manufacturing formula, master production record, or master formula record.

Additionally, the master record comes in handy when pharma companies parcel out production responsibilities to outside parties known as contract and developing manufacturing organizations (CDMOs). These organizations follow the master formula record to ensure that they produce quality products safely, consistently, and in compliance with regulatory standards.

Pharmaceutical production features another compliance document closely linked to the manufacturing batch record. This is known as the batch record, batch manufacturing record, or batch production record.

The similarity lies in the fact that both documents keep track of the approved ingredients and production techniques used by a pharmaceutical manufacturing and are required by regulators to enforce good manufacturing practices (cGMP).

However, there’s a crucial difference. The batch record is a copy of the master. It guides and records the formulations and techniques on the production line to manufacture a specific batch of products. So, apart from providing guidance, the batch record also offers proof that a particular product batch was manufactured according to the procedures detailed in the master formula record.

In other words, the master batch record is a template that businesses can use when creating an individual batch record during the production of a singular batch.

In accordance with 21 CFR Part 211, pharmaceutical manufacturers are required to maintain their master batch records with certain details and information. Some of the items that must be included in the MBR includes:

• Product name and identification code

• Pharma product characteristics and properties

• A Bill of Materials detailing the specific ingredients to be added to that particular product formula. This also includes the various sizes and amounts of said ingredients.

• Size of the entire batch

• Bill of Process showing production line setup, equipment and tools required to make the product

• Work instructions for personnel at each stage of the production line

• Expected batch yield

• Health and safety information to be observed during the production process

• Quality assurance and control procedures and acceptable test benchmarks

• Approved packaging and storage

These details help ensure that the entire product lifecycle is documented and accounted for, providing evidence that the drugs produced meet the necessary health and safety standards.

Even today, it’s not uncommon for pharmaceutical manufacturers to use paper-based records for their documentation and compliance.

However, the evolution of manufacturing techniques has led to more complex requirements for pharmaceutical production, necessitating more robust compliance document management.

Additionally, manufacturers now have a wide variety of different solutions to choose from when it comes to digitizing their compliance documentation. Some of the key benefits of going digital include:

Integration with ERP systems: Master batch records contain material and process information pertinent to core manufacturing efforts. Integrating the documents with enterprise resource planning systems allows pharma manufacturers to coordinate and manage materials more effectively.

Reduced human errors: Digital solutions eliminate the need for manual data entry, significantly improving data integrity. This ensures that accurate data is collected and documented across every single step of the production process.

Furthermore, some solutions can leverage the master batch record to provide operators with interactive work instructions, allowing personnel to execute their roles more competently and accurately.

Simplified compliance with ALCOA+ principles: In addition to reducing errors associated with human data entry, digital solutions help ensure that documents are aligned with ALCOA as outlined by the FDA.

Not only does implementing a digital compliance solution ensure the data is accurate, but it also ensures legibility, attribution, consistency, and availability to all necessary stakeholders and regulators.

Accountability: Manufacturing batch record software keeps track of all changes made to the document. Not only does this negate the need for double entries across documents, but it also ensures that edits are attributed to the responsible personnel.

Faster information access and retrieval: Compliance audits are significantly more manageable when officers can access documents quickly. Additionally, production personnel can easily retrieve the master record for reference.

If you’re working in pharma or biotech, paperwork is evidence that the process is under control. And nowhere is that scrutiny sharper than with Master Batch Records (MBRs).

An MBR is more than a template, it’s the production map that defines exactly how a batch should be made, checked, and released. Regulators expect those records to be airtight. Gaps such as missing signatures, incomplete instructions, or using an unvalidated electronic system don’t just create headaches; they show up in inspection reports, warning letters, and sometimes product holds.

U.S. FDA: 21 CFR Part 211.186–211.192

FDA’s CGMP rules lay out clear expectations:

• §211.186 requires a written master production and control record for each product. That includes the formula, step-by-step manufacturing instructions, sampling, and control procedures. It has to be drafted, reviewed, and signed off by quality.

• §211.188 describes what must appear in batch production records, actual component weights, dates, equipment identifiers, in-process test results, and operator and supervisor signatures at key stages.

• §211.192 requires full investigation and documentation of any discrepancy or failure, without exceptions.
  

Across all three sections, FDA is looking for records that are complete, contemporaneous, and attributable and these stand as pillars of their data integrity stance.

EU GMP: Annex 11 and ICH Q7

In Europe, two standards are especially relevant.

• Annex 11 covers computerized systems. Any digital platform used for MBRs must be validated, secure, and equipped with audit trails. User permissions, version control, and data retention practices all fall under this expectation.

• ICH Q7 (for APIs) reinforces that MBRs must be defined, reviewed, approved, and controlled. Only current versions should be in circulation, and historical records must be retrievable and intact.
  

Where Manufacturers Get Caught

Even though the rules are clear, inspectors keep flagging the same issues:

• Records missing signatures, dates, or quantities

• Use of electronic systems without proper validation

• Operators following outdated instructions because of poor version control

• Gaps in traceability which means no clear record of who performed each step

• Late entries that weaken data integrity

In fact, FDA’s 2023 inspection data showed that documentation gaps, including problems with batch records were cited in more than one out of every five 483s issued to drug manufacturers.

You may already be familiar with the difference between a Master Batch Record and a Batch Record. One is the approved template, the other is the completed record for a specific lot. But there’s a third term worth knowing, especially if you work across multiple regulated industries: the Master Production Record.

Here’s how the three compare:

Paper Master Batch Records have served the industry for decades, but they no longer fit today’s regulatory or operational realities. Instead of supporting compliance, they often slow teams down and expose manufacturers to unnecessary risk.

1. Manual Entry Brings Manual Errors
On paper, every number, signature, and note depends entirely on human accuracy. That leaves plenty of room for mistakes that can stall production or invite regulatory findings.

Take a simple example: an operator writes “25.0 g” instead of “2.50 g” for an active ingredient. The discrepancy isn’t caught until QA review. Now the release is delayed, a deviation is opened, and the investigation consumes resources that should be focused on production.

These aren’t isolated events. FDA inspection data shows documentation errors remain one of the most common reasons for 483 observations. Paper doesn’t provide any built-in checks to prevent them.

2. Reviews Take Longer Than They Should
Approving a paper record is a slow, manual grind. QA has to flip through pages, chase down missing initials, and try to interpret unclear handwriting.

If a field is blank or a deviation needs follow-up, the whole batch release is put on hold. And because paper isn’t searchable, root cause investigations often sprawl across binders, spreadsheets, and scanned copies instead of being contained in a single system.

3. Audit Readiness Suffers
Paper makes inspections harder than they need to be. When regulators ask for a specific record, it can mean digging through cabinets or warehouses of archived boxes.

Problems like missing pages, poor legibility, or incomplete fields only add to the risk. And when records are purely paper, it’s almost impossible to show that production data is being controlled in real time which is a point inspectors are increasingly focused on.

Master Batch Records are more than documentation—they’re proof of control in highly regulated environments. By moving beyond paper, manufacturers reduce errors, speed up reviews, and strengthen their audit position from day one.

As we’ve outlined, the importance of documentation in pharmaceutical manufacturing can not be overstated.

By implementing a solution like Tulip, businesses are able to streamline their documentation and make regulatory compliance a seamless part of their operations.

If you’re interested in learning more about how Tulip can help you manage your master batch records, reach out to a member of our team today!