GMP work instructions and batch manufacturing records, drafted from your validated process

In GMP manufacturing a work instruction is also evidence. Each line is something an operator does and a place to record that they did it, and an inspector may read the executed record years later. INKFLOW drafts GMP work instructions, master processing and packaging instructions, and batch manufacturing record templates from your process data.

Name the document type in the brief, for example 'batch manufacturing record template for tablet compression', and the writer works from guidance for GMP documentation. It asks for your site and licence, the markets you supply, the manufacturing formula, rooms and equipment, critical process parameters and in-process controls.

The limits, stated directly: the draft is written from your approved data, and a missing parameter, yield limit or hold time becomes a marked placeholder. It does not certify GMP compliance, and it must pass through your quality assurance review, change control and approval before it is used on a batch.

Start a GMP work instruction

Drafting a GMP batch record from your process data

1
State the site and the rules
Manufacturer, site, licence type and whether you supply the UK, the EU, the US or several, since that decides which GMP expectations the document should reflect.
2
Give the formula and the equipment
Every starting material with item code and quantity per batch, expected yields with their limits, and the rooms and equipment IDs with qualified operating ranges.
3
Supply the validated steps and controls
The processing sequence as validated, critical parameters with targets and limits, sampling points with acceptance limits, and the hold times your data supports.
4
Review under change control
You see the price before you pay. Production and QA then go through the draft line by line, and it is approved through your own document and change control procedures.

How GMP work instructions are written

One action, one record

Each row is a single action with space to record the result, the time and who did it, so an executed record shows exactly what happened.

Second-person checks where you require them

Steps that need verification by a second person carry that block. Which steps they are is your decision, taken from your procedures.

Limits never invented

Critical parameters, in-process limits and yields appear only as your validation gives them.

Equipment preparation by reference

Cleaning, assembly, calibration and sterilisation procedures are cited by number before the batch starts, not rewritten inside it.

Operator hazards in line

Potent, sensitising, flammable or dusty materials get their containment and PPE requirements at the step where exposure happens.

Packaging instructions

Component codes, artwork references and coding positions, with room to reconcile what was issued, used and returned.

GMP decisions that stay with your quality unit

INKFLOW does not validate processes, approve deviations, release batches or act as a Qualified Person. It cannot tell you whether a parameter is right; it can only write down the one you give it.

If your records are electronic, the text can be drafted for that system, but INKFLOW does not configure or validate a computerised system. Good documentation practice, deviation and change control are referenced by your own procedure numbers.

Questions

Which GMP rules does it write to?

The ones for the markets you name: for example the EU and UK GMP guide's chapter on documentation, or the US production record requirements in 21 CFR Part 211. The draft reflects their expectations; it does not claim your process meets them.

Is a work instruction the same as a batch record?

Not quite. A work instruction tells someone how to do a task; a master batch record is the controlled template each executed record is issued from. Say which you need, or both, and how they relate.

Can it handle packaging as well as processing?

Yes, as a packaging instruction, provided you supply the components, codes and artwork references.

Can someone with GMP experience review it?

Ask for a human reviewer when you order. A person sends a quote, and nothing is charged unless you take it up.

Do prices include VAT?

Prices include any VAT; nothing is added at checkout.

We are an organisation. How can we pay?

Single orders are paid by card at checkout. For subscriptions and repeat orders, care homes, councils and businesses can ask about paying by Direct Debit or standing order at app.inkflowstudio.org/organisations.

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