Batch and production record basics (GMP)

A batch record, also called a production record, follows one run of a product from start to finish. It shows what was made, what went into it, who did each step, and who reviewed the result. In many GMP environments it is one of the most important documents in the building, because it lets you trace what happened to a specific lot long after it left the floor.

This page is a general introduction to the paperwork. It is not legal advice, and it does not guarantee that any business meets a regulation. Your regulator, your customers and your own quality system decide what you need.

Master record and executed record

Two terms come up constantly. The master record is the approved template: the correct recipe, steps, limits and checks for the product. The executed record is a fresh copy of that template filled in during one run. Each executed record gets its own batch or lot number. The master stays under document control, and only current copies are issued to the floor.

What a batch record usually captures

• Product name, code and the batch or lot number.
• Date, start time and finish time.
• Planned batch size.
• Materials used, with the amount weighed, the supplier lot number and who weighed it.
• Equipment used and confirmation that it was clean and ready.
• Each processing step, with initials and a time or reading where needed.
• In-process checks, such as weights, temperatures or visual inspections.
• Final yield, and a comparison against the expected amount.
• Any deviation, with what happened and what was done about it.
• Review and release signatures.

A simple step layout

Notice that the target is printed next to a blank for the actual value. The person filling it in should never have to look somewhere else for the limit.

Design it for the floor

Batch records get used with gloves, in a hurry, sometimes standing up. Give each step one line and one action. Make the blanks big enough to write in. Print units next to every blank, use tick boxes for yes or no checks, and put the signature spots where the work happens. Our guide on cleaning up a messy checklist or form goes through these layout fixes with examples.

Fill it in as you go

The expectation is simple: write entries at the time the work is done, in ink, legibly, with a date and initials. If you make a mistake, put a single line through it and add your initials, the date and a short reason. Do not erase, cover or rewrite. The full set of habits is in our good documentation practice tips.

Review before release

A second person normally reviews the completed record before the product is released. They look for blank fields, missing signatures, readings outside the limits and unexplained changes. Catching a gap at that point is much easier than finding it during a customer complaint or inspection. For the wider picture of how batch records sit among procedures, forms and training records, see our GMP documentation basics.

Common mistakes to avoid

• Using an old version of the master record.
• Instructions that are long paragraphs instead of single steps.
• No space to write the actual value next to the target.
• Filling in the record after the fact from memory.
• Deviations that are noticed but never written down.

Quick test: Pick a batch number. If you can open one record and see what went in, who did each step and who signed off, the record is doing its job.