In this guide 6 sections
An electronic batch record for a tablet line needs a header, dispensing, granulation and drying, blending, compression, coating, blister packing, reconciliation and a release block. Each section has its own checks, equipment links, limits that warn on entry, and signatures, and the sections run in a fixed order.
Start with the header and dispensing
The header fixes the identity of the batch: product, strength, batch number, batch size, master record version, manufacturing date and planned lines. It pulls from the master record. Nobody can type over it. Think of the header as a contract between the master record and this batch, because every later section reads its limits and its materials from here.
Dispensing comes next. For each material the record shows the required weight, the lot drawn, the balance used and the actual weight. A second person verifies, and an out-of-range weight should stop the step.
A raw material lot that is expired or not yet released should be refused here. Not found later.
- Master record version and approval date
- Material, lot, required and actual weight
- Balance ID with calibration status
- Dispensed by and verified by
Granulation, drying and blending
Wet granulation brings many parameters. Record binder preparation, mixer speed, impeller and chopper settings, mixing time and the end point. For a fluid bed dryer capture inlet temperature, air flow and the loss on drying at exit.
Blending needs less. It records the blender ID, load quantity, speed and time. Lubricant addition is a separate step with its own timer.
Each step links to an equipment record, so if the dryer’s calibration lapsed last week, the record says so before the operator starts. No one has to remember.
Compression and in-process checks
Compression is the most data heavy stage. The record needs press ID, tooling set, turret speed, compression force and the run start and stop, plus periodic checks of weight, thickness, hardness, friability and disintegration.
Enter each check with a time, the sample result and the limit. A reading outside limits should flag at once and open a deviation, rather than sit unnoticed until the next supervisor handover.
Keep rejected tablets and sweepings as a quantity. They feed reconciliation later. A list of in-process checks at fixed intervals, with every reading marked as passing or failing, gives QA more than one summary entry at the end.
- Individual and average tablet weight
- Thickness and hardness readings
- Friability and disintegration results
- Metal detector or dedusting check
- Core yield at end of compression
Coating, blister packing and reconciliation
Coating needs suspension preparation, pan load, spray rate, inlet and exhaust temperature, weight gain and appearance. Tablets then move to blister packing, where line clearance is the key entry before anything starts.
Packing records the foil and PVC lots, printed lot and expiry codes, leak test results and a camera or visual check. Cartoning and shipper steps follow the same pattern. Print codes matter, since a mixed-up foil roll or a wrong expiry print is a recall risk and not just a rework.
Reconciliation closes each stage. Issued, used, rejected and returned quantities must balance within the limit set in the master record, and a gap blocks the next step until someone explains it.
Review by exception and release
The final block gathers all deviations, out-of-limit readings, edits to entries and unsigned steps. QA reviews that list first and opens the full record only where it points.
Release needs the reviewer’s signature, the date and the disposition. A locked record cannot change without a reasoned amendment that keeps the old value visible.
Before go-live, run the template on a trial batch, on paper and on screen together. Compare the two line by line.
Batch record section checklist
A one page template listing the nine sections of the record in order: header, dispensing, granulation, drying, blending, compression, coating, blister packing and release. For each section the rows give parameters, unit, limit, equipment link, signature roles and deviation trigger.
Open a blank worksheet to printQuestions owners ask
Can we convert our paper master record directly?
Use it as the starting point, but redesign the layout. Paper copies repeat fields and carry notes in margins, so each field should be decided again as data, a limit or a signature.
How do limits work on screen?
Each parameter carries a lower and upper limit from the master record. An entry outside the range warns the operator and, for critical parameters, blocks the step until QA decides.
What about readings from machines?
Some presses and balances can send values directly, which removes typing. Where they cannot, the operator keys the value and a second person checks the critical ones.
Who approves a change to the template?
The same people who approve a paper master record: production, QA and, where it applies, regulatory. A new version is issued and the old one stays readable.