What a production system has to cover in a plant making medicines, cosmetics or supplements, what inspections look at, and which questions to ask any supplier before you choose.
Pharmaceutical manufacturing
Production software for the pharmaceutical industry
Context
Why pharmaceutical manufacturing needs a different kind of software
An ordinary ERP keeps track of what comes in and what goes out. In a GMP plant that is only half the story: every batch must be able to show how it was made, who did each step, with which approved materials and on which clean, calibrated equipment. And the evidence has to stand up to an inspection years later.
Functional requirements
What it must cover, area by area
For each area, a few things to ask for at a demo. If the supplier cannot show them on screen, they most likely do not have them.
Receipt and quarantine
Raw materials stay in quarantine until the quality decision and cannot be used before it.
At the demo, ask to see:
- a container scanned before approval and refused when issued to production;
- a purchase order to a supplier not approved for that item, blocked.
Quality control
Versioned specifications, results for every requirement, verdict calculated automatically.
At the demo, ask to see:
- an out-of-specification result that opens an OOS investigation and blocks the batch;
- the QA decision per batch, separate from the laboratory role.
Electronic batch record
The master procedure becomes a record for each batch, completed step by step on a tablet. Details in the electronic batch record guide.
At the demo, ask to see:
- a skipped step or a wrong material scanned, refused;
- equipment with expired calibration, which requires a reason and becomes an exception.
Packaging and reconciliation
When the batch closes, the material balance: issued, consumed, returned, lost.
At the demo, ask to see:
- a loss above the threshold, flagged automatically;
- unused materials returned to the warehouse, with approval.
Batch release
Review starts from exceptions, not from dozens of pages, and ends with an electronic signature.
At the demo, ask to see:
- an unreleased batch that is visible in stock but cannot be shipped;
- everything affecting the batch (deviations, OOS, changes) before signing.
Quality system
Deviations, CAPA and change control start in production or in the lab and stay linked to the batch. Details in the deviations and CAPA guide.
At the demo, ask to see:
- a deviation reported from the shop floor, linked to the batch, with CAPA and an effectiveness check.
Equipment
Calibration, maintenance, cleaning and qualification, kept electronically.
At the demo, ask to see:
- the cleaning and calibration status of the equipment, visible in the batch record.
Warehouse, shipping and recalls
Batch status at every scan, allocation by batch and container, recalls started from the batch.
At the demo, ask to see:
- the list of customers who received a batch, generated on the spot.
Regulations
What inspections look at
The references below come up in almost every conversation about software in pharmaceutical manufacturing.
| Reference | What it covers, in short | Where it matters in software |
|---|---|---|
| EU GMP, Part I | good manufacturing practice for medicines | batch record, release, deviations |
| EU GMP, Annex 11 | computerised systems: validation, audit trail, security, continuity | the whole system |
| 21 CFR Part 11 | electronic records and signatures, for the US market | signatures, audit trail, access control |
| GAMP 5 | risk-based guidance for validating computerised systems | system categorisation and validation effort |
| ALCOA+ | data integrity principles | every record |
| ISO 22716 | good manufacturing practice for cosmetics | batch traceability, specifications |
| FMD (serialisation) | safety features of prescription medicines | serialisation data per batch |
What Annex 11 and 21 CFR Part 11 require for records and signatures is explained in the electronic batch record guide.
Data integrity
Questions to ask any supplier
Good answers are short and can be demonstrated
- Can anyone, including an administrator, change or switch off the audit trail?
- What happens to a signature if the signed data changes later?
- How is the requester separated from the approver? Can the administrator bypass the separation?
- Where does the system time come from, and who can change it?
- How is backup done, where is it kept, and how is restoring tested?
- How do you export the full history of a batch for an inspector, without piecing it together from several places?
- What happens to the data if you end the contract?
A “it can be configured” without a demonstration usually means “no”.
Validation
Software is not certified, it is validated
There is no GMP certificate for a program. The system is validated at each plant, on its own processes, and the supplier should give you the starting point: user requirements with a traceability matrix, risk assessment, IQ, OQ and PQ templates and operating procedures. What each part does, and how to keep the system validated after go-live, is explained in the GMP software validation guide.
Implementation
How to implement it without stopping the plant
Duration depends on the number of products, procedures and links to the ERP, and is set after the analysis, together with the validation plan.
Sectors
Cosmetics and supplements: what differs
Cosmetics
Good practice follows ISO 22716, and products must comply with Regulation (EC) No 1223/2009. Traceable batches, controlled specifications and shelf lives matter. Electronic signatures and batch records help, even if the formal requirements are lighter than for medicines.
Food supplements
The rules come from food law and HACCP principles. Raw material specifications, supplier certificates of analysis and shelf lives matter, and large customers often bring their own audits.
We built DataFlows Pharma on the requirements on this page; the product page shows what it does, module by module, and the case study shows how a medicines plant moved away from paper. If your plant is not in pharma, read about software for industrial manufacturing.
Frequently asked questions
Usually, yes. The ERP stays for purchasing, sales, invoicing and cost. GMP records (batch record, quality control, deviations) have requirements an ordinary ERP does not cover. The two are connected: items, stock and orders flow between them.
No. The GMP authorisation is granted to the plant, not to the program. Software is validated by the user, and the supplier gives you the documents validation starts from.
Inspections accept both, if they are controlled: access, backup, continuity and an assessed supplier. Many plants prefer a server inside their own network; what matters is that the choice is documented in the validation.
Yes. Many start with the warehouse and quality control, then move to the electronic batch record.
The steps, parameters and checks. What changes is where they are filled in, not the process.
Yes. GMP requirements are the same regardless of size. In a small plant the amount of configuration differs, not the principles.
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