What a batch record contains

A batch record is the written account of how one specific batch of material was made. It starts as a blank copy of an approved master document and is filled in, step by step, as the work happens. When it is complete it shows what was used, what was done, what was measured, who did each part and who checked it. A quality reviewer reads it before the batch is released, and it is kept afterward as the permanent evidence that the batch was made the way it was supposed to be.

Master record and batch record

Two documents are involved, and the distinction matters. The master record, called the master production and control record in US regulations and the manufacturing formula and processing instructions in EU GMP, describes how every batch of a product should be made. It lists the materials and quantities, the equipment, the sequence of steps, the process parameters and their limits, and the checks to be performed. It is written once, reviewed, approved and placed under document control.

The batch record is a copy of the master, issued for one batch and given that batch’s number. The operators record what actually happened against what the master says should happen. Because the batch record is issued from the current approved master, a reviewer can tell from it which version of the process was followed. A batch record written on an old or unapproved form is a finding on its own, whatever it contains.

What goes into it

The specific contents depend on the product and the process, but the requirements in 21 CFR Part 211, in Chapter 4 of the EU GMP guidelines and in ICH Q7 for active ingredients cover the same ground. A complete batch record typically includes:

• the product name, the batch number and the version of the master it was issued from;
• the dates, and where relevant the times, at which significant steps started and finished;
• the identity of the main equipment and the rooms or lines used, so that cleaning and maintenance records can be connected to the batch;
• each starting material with its own lot number and the quantity actually weighed or measured, with the identity of the person who weighed it and the person who checked;
• process readings such as temperatures, pressures, times and mixing speeds, recorded as they are taken;
• results of in-process checks and the limits they were judged against;
• yields at defined stages, compared with the expected range;
• labeling and packaging details, including specimens of the printed labels or a record of the label lot used;
• any departure from the instructions, with a reference to its investigation;
• signatures or electronic approvals for each step, and the final review.

Why the details matter

Each of those entries answers a question a reviewer may need to ask later. The starting material lot numbers connect the batch to its suppliers’ certificates and to the incoming tests. The equipment identities connect it to calibration and cleaning records, so that if a balance is later found to be out of calibration, every batch weighed on it can be found. The yield figures show whether material was lost or gained in a way that should not happen. The deviation references show that anything unexpected was noticed and dealt with, not quietly absorbed.

The second signature on a critical step, often called a verification or a check, exists because a single person can misread a scale or pick up the wrong container. A check made by a second person at the time is far more reliable than one made from the paperwork afterward.

Review and release

Before a batch is released, the quality unit reviews the completed record. The reviewer checks that every entry is present, legible and signed, that all results fall within their limits, that calculations are correct, that corrections were made properly with the original still readable, and that every deviation is closed or has an approved disposition. Laboratory test results for the finished batch are reviewed alongside it. Only when both are complete and acceptable is the batch released. In the European Union that decision is certified by a Qualified Person; in the United States it rests with the quality control unit.

A batch record with gaps cannot be completed afterward from memory. If an entry is missing, the honest course is to document that it is missing, investigate why, and decide on the batch with that knowledge, rather than fill the gap after the fact. A late entry that is dated as if it were made at the time is a data integrity failure, and usually a more serious one than the gap it was meant to cover.

Once released, the batch record is retained for a defined period, usually tied to the expiry date of the batch, so that it is available if a question arises about the batch while it is still in use and for some time after. A certificate of analysis summarizes the test results for a batch; the batch record is the fuller account behind it, and the place a reviewer goes when the certificate raises a question it cannot answer.