Form: batch journal and deviation report (GMP)
How to structure the documentation of a batch so it meets GMP requirements
A batch journal is the ongoing documentation of everything that happens to a particular batch — from raw materials to finished product. Use this form as a template for which fields a batch journal typically should contain, and how a deviation is documented if something does not go as planned.
§The batch journal's fixed fields
| Field | What it should contain |
|---|---|
| Batch number | Unambiguous identification of precisely this batch |
| Raw materials and quantities | What raw materials, which suppliers/batches and what quantities have been used |
| Process steps and timing | Each step in the process with start and end time |
| Measured values | Temperature, pressure, pH, or other parameters relevant to this particular batch |
| Performed by / checked by. | Who performed and who checked each step |
| Release decision | The final decision on whether the batch may be released |
§How to fill in as you go
- 01Fill in in real time while you perform the step—not from memory afterward.
- 02Never use an eraser or correction fluid: cross out incorrect entry with one line, write the correct information, and sign and date the correction
- 03Let no fields stand empty without an explanation — an empty field cannot be distinguished from a forgotten step
§When something deviates—the deviation report
| Field | Content |
|---|---|
| What deviated | Short factual description of what happened |
| When and where | Time and process step where the deviation occurred |
| Immediate action. | What was done immediately |
| Assessment of significance | What significance the deviation has for the batch's quality |
| Corrective/preventive action | What's done so it doesn't happen again |
| Approved by | Who assessed and closed the deviation |
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