Case studies / Pharmaceutical Manufacturing
Case studyAudit-ready batch records for a generics manufacturer
A generics manufacturer moved batch records, material control and change control onto one system across three facilities, shortening batch release and making audits far less disruptive.
Overview
A privately held manufacturer of generic tablets, capsules and oral liquids with three facilities in Central Europe, supplying wholesalers, hospital tenders and contract customers in more than twenty countries.
Scale. Around 3,200 batches a year across 250 products, with controlled substances at one site and regular inspections by national regulators and customer auditors, delivered as a phased, multi-location programme.
The challenge
Records were scattered across files. Batch records were printed, filled in by hand on the production floor and reviewed page by page by quality assurance. Supporting evidence, from weighing printouts to cleaning logs and laboratory results, sat in binders, shared drives and the laboratory system. Assembling a complete batch file for release could take days.
Each facility handled batch genealogy, controlled materials and expiry in its own way. Tracing which raw-material lots went into which finished batches, and where those batches had been shipped, meant searching paper and spreadsheets. Controlled-substance reconciliation at one site was entirely manual.
Change control and validation followed different procedures at each site. When an inspector arrived, quality teams spent weeks gathering documents, and the inspection itself pulled senior staff away from production. A minor observation at one inspection about inconsistent records had made leadership determined to fix the root cause.
The solution
Operators now complete batch records electronically at the line. Each step is checked as it is recorded: weights against limits, materials against the recipe, equipment against its cleaning status. Deviations are raised immediately rather than discovered at review, and quality assurance reviews by exception instead of page by page.
Genealogy is captured automatically. Every raw-material lot, intermediate and finished batch is linked, so a complete trace from supplier to customer takes minutes. Controlled materials are reconciled continuously, and expiry dates drive warehouse picking and alerts.
Change control and validation follow one procedure across the three facilities, with approvals, impact assessments and evidence held in one place. Shared master data for products, materials and equipment underpins it all, and group reporting shows release times, deviations and inspection readiness.
The engagement
- Eleven months
- Seven specialists, with quality assurance, production, warehouse and validation leads
- Process mapping, electronic batch records and genealogy, controlled materials and expiry, validation and change control, shared master data, pilot, validated rollout.
Integrations
- Laboratory information system
- ERP and warehouse systems
- Quality management and document control
- Secure identity and audit logging
How we delivered it
- 01
Map the work with the people who do it
Seven weeks
We walked batches through each facility with operators, quality reviewers, warehouse staff and the qualified persons who release product. Together with the quality director we agreed the scope and the measures: release time, audit preparation effort and record completeness.
- 02
Design common processes and build integrations
Fourteen weeks
Quality and production designed one electronic batch record standard, one approach to genealogy and expiry, and one change-control procedure for all sites. Integrations linked the laboratory system, warehouse and ERP, with identity and audit logging meeting electronic-records requirements.
- 03
Pilot in one facility
Nine weeks
The smallest site piloted with two product families. The pilot showed that some master recipes differed from the paper records in use, and that operators needed tablets mounted at the line rather than shared terminals. Both were fixed before validation of the wider rollout.
- 04
Roll out in waves and track results
Sixteen weeks
The remaining facilities followed under formal validation. Leadership reviewed release times, deviations, audit effort and expiry write-offs monthly.
Results
- Audits became less disruptive and quicker to prepare
- Batch release time shortened
- Complete electronic genealogy for every batch
- Teams worked from the same data across locations
Audits became less disruptive. Inspectors and customer auditors can be shown complete batch histories on screen, and preparation that used to take weeks now takes days. The most recent regulatory inspection at the largest site concluded with no observations about record keeping.
Batch release time fell substantially because quality reviewers no longer assemble files by hand. Product reaches customers sooner and less finished stock waits in quarantine.
Teams in all three facilities work from the same data and procedures, so staff can move between sites and leadership reviews results monthly from one set of reports.
Traceability has also been tested for real. When a supplier notified the company of a possible issue with one excipient lot, quality staff identified every affected batch and every customer shipment within an hour, and confirmed that no product needed to be withdrawn. Under the old system, the same exercise would have taken several days of searching binders.
Inspection week used to stop the business. Now we open the system and show them. It is the calmest audit season we have had.
What made the difference
The client moved batch records online and shortened release time. A small pilot exposed problems, such as recipes that differed from paper records, while they were cheap to fix.
