To ensure quality and safety in pharmaceutical production, Good Manufacturing Practices (GMP) require detailed documentation of production processes.
What is a master batch record?
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.
Difference between a batch record and the master batch record
Both documents keep track of the approved ingredients and production techniques used by a pharmaceutical manufacturing and are required by regulators to enforce 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.
What is included in a master batch record?
In accordance with 21CFR 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
- Size of the entire batch
- Bill of Process showing production line setup, equipment and tools required to make the product
- Work instructions for personnel
- 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.
What is included in a batch record?
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, including dates of completion for each step
- Initials of the person performing and verifying each step
- Health and safety information, 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, including the date and time completed
- 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
- Batch Production Record in Pharmaceutical Industry
- Pharmaceutical Finished Product Specification and Template
Resource Person: BARBARA PIROLA