Pharmaceutical plants in Karachi's Korangi and SITE, Lahore's Sundar and Kot Lakhpat areas and around Islamabad, and the chemical and cosmetics units beside them, work under a discipline most factories never see. Every raw material is tested before use, every batch has a record, every finished pack waits for QC release, and expiry dates run through the whole chain. Many plants still hold this in paper batch records, a store register and an accounts package that does not know what quarantine means.
This guide covers how software can hold your records. Regulatory requirements, including what the Drug Regulatory Authority of Pakistan expects and what your GMP inspections look for, are for your regulatory adviser and quality head to confirm.
Stock that carries a status
In a pharma ERP, stock is never just a quantity. Each lot of raw material, packing material and finished goods carries a status, and the system will not let the wrong status move.
| Status | Meaning | What the system allows |
|---|---|---|
| Quarantine | Received, not yet sampled | No issue to production; sampling only |
| Under test | Sample with QC | No issue; visible as incoming stock |
| Released | Passed QC with a release reference | Issue to production or sale, earliest expiry first |
| Rejected | Failed QC | Return to supplier or destruction, with a record |
| On hold | Released earlier, now under investigation | Blocked until QC changes the status |
Formulas and batch records
The formula, or master formula, lists each ingredient and its quantity for a standard batch size. It is versioned, and only the approved version can be used to create a batch. When planning raises a batch, the ERP scales the formula, reserves released raw materials by lot and expiry, and prints the issue sheet. Dispensing records the actual lot and quantity weighed. Production then records stages, yields and in-process checks, and packing records packs produced, so the batch record ties together who did what, with which material lot, on which date.
QC release
QC sees every lot waiting for testing. Results are entered or attached, and the QC head releases or rejects with a reference. Finished goods follow the same rule: packed stock sits on hold and cannot be sold or dispatched until released. If a complaint or recall comes in, a batch search shows which raw lots went into it and which distributors received it.
Expiry from end to end
- Raw materials and packing materials carry expiry or retest dates, and issue follows earliest expiry first.
- Finished goods carry manufacturing and expiry dates printed from the batch.
- Near-expiry reports by product and distributor, so returns are planned, not discovered.
- Retest reminders for raw materials that can be extended after testing.
Expiry and batch handling at the pharmacy end is covered in our guide to pharmacy software with batch and expiry. The manufacturer's side has to feed it correct data.
Selling through distributors
Most Pakistani pharma companies sell through distributors and medical reps. The ERP holds the distributor list, price lists, bonuses and schemes, and records each dispatch by batch. Returns come back by batch too. For the field side see our distribution software guide and the pharmacy industry page.
List your statuses
Write down every status your QC uses today and the rule for moving between them.
Load approved formulas
Enter the current approved version of each formula, with its approval reference, for products in production.
Run parallel batches
For a few batches, keep the paper record and the system record side by side and compare them.
Train dispensing and QC
Train the dispensing team and QC on the live system, on their own materials, before switching over.
Agree with your quality head
Have the quality head and regulatory adviser confirm the system records are acceptable before paper stops.
Do not try to digitise everything on day one. Most plants start with stock statuses and dispensing, because that is where paper causes the most mix-ups, then add batch records stage by stage. Packing materials such as printed cartons, foils and leaflets deserve the same care as active ingredients, because an old artwork version on a carton is a recall waiting to happen. The ERP can block issue of a packing material lot whose artwork version is no longer current.
Operix and pharma projects
Operix builds ERP software in Pakistan from Old Clifton, Karachi, with on-site discovery and training for Karachi plants and online work elsewhere. We design every screen with your production and QC heads before it is built. We are a software company, not a regulatory consultancy, and we will say so in every meeting. See manufacturing ERP in Pakistan for the wider factory picture, or book a demo.
Questions people ask
Is your ERP validated for pharma?
Validation is done for your plant with your quality team, against your procedures. We support it with documentation and test records, and your regulatory adviser confirms what is needed.
Can it handle chemical and cosmetics plants too?
Yes. The same ideas of formulas, batches, QC status and expiry apply. Hazard and labelling rules differ and should be confirmed with your adviser.
Can QC attach test reports?
Yes. Results can be entered as values or attached as files against the lot, and the release carries the QC head's reference.
Do you have an office in Lahore?
No. Operix works from Karachi. Lahore and Islamabad plants are served online, with visits when the project needs them.
