ERP for the pharmaceutical and cosmetics industry
Electronic batch record, pharmaceutical release, status control and expiry management: the ERP built for a GMP environment where the data carries accountability.
Pharmaceuticals & cosmetics
- Electronic batch record
- Statuses and release
- Expiry and FEFO
Nothing leaves without release
On a site operating under GMP, a manufactured product is not an available product. It stays in quarantine until the release decision, taken on the strength of a complete batch record and signed by a named responsible person.
The whole information system has to follow this logic of statuses. An ERP that makes stock available as soon as production is declared organises, structurally, the issue of unreleased batches.
The batch record itself often stays on paper: several dozen pages per batch, read line by line before release. It is the main delay between the end of manufacture and availability, and the main source of documentary discrepancies at inspection.
Expiry, weighing and data integrity
Date control is a fundamental constraint: issue nearest to expiry (FEFO), calculation of the finished product date from the most constraining component, automatic blocking of an expired component. Issuing on FIFO instead of FEFO is paid for in destroyed stock.
Central weighing must be guided and recorded: expected component, tolerance, check on the status of the batch being weighed. In cosmetics, ISO 22716 sets comparable requirements, and 21 CFR Part 11 governs the electronic signature as soon as a North American market is in view.
AVIA ERP carries the quarantine and release statuses, takes the batch record off paper, applies FEFO on issue, guides the weighing sequence and logs every intervention in a non-repudiable manner.
What a GMP site expects from its ERP
- Electronic batch recordBuilt up as manufacture proceeds, with in-line checks, traced deviations and review by exception rather than page by page.
- Statuses and releaseQuarantine, blocked, released, rejected. No issue movement is possible outside released status, with the decision signed and time-stamped.
- Expiry and FEFOIssue nearest to expiry, finished product date calculated from its components, expired batches blocked.
- Guided central weighingAssisted weighing sequence, status and tolerance checks, automatic recording in the batch record.
- Data integrity and signatureNon-repudiable audit trail, electronic signature and double check on critical operations, in line with 21 CFR Part 11 expectations.
The direct benefits for your industrial company
Release in hours rather than days
Review by exception replaces the page-by-page check of a paper record.
No unreleased batch leaves the site
The prohibition is carried by the statuses in the system, not by the vigilance of a storekeeper.
Fewer destructions on expiry
FEFO applied on every issue runs the batches down in the right order, automatically.
An inspection that rests on the system
Records, deviations and signatures are produced from the tool, with nothing to reconstruct.
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Averaland
Cosmetics manufacturing.
The industries AVIA ERP covers
Every industrial sector demands its own rigour. AVIA adapts to your regulatory constraints through focused domain modules.
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