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- ERP + Quality for Pharma
- Who it's for
- Tablet manufacturing
Tablet manufacturing
A tablet manufacturer can keep each finished lot connected to its product, batch status, test results and quality review. The product record holds dosage form, strength and storage condition. The batch holds number, quantity, manufacturing and expiry dates, line and site. A reviewer can move from that lot to its specifications and exception records before deciding on release.
How ERP + Quality for Pharma is set up for you
Production
Production Manager records the lot and follows its lifecycle from Planned into manufacturing and testing.
Quality control
QC Analyst records results against the batch and the product's applicable specification, with an outcome and analyst note.
Quality assurance
QA Manager investigates deviations, checks corrective actions and reviews calibration attention.
Release
Qualified Person records the independent decision. The release posting workflow handles an approved batch and records its operation receipt.
A tablet manufacturer can keep each finished lot connected to its product, batch status, test results and quality review. The product record holds dosage form, strength and storage condition. The batch holds number, quantity, manufacturing and expiry dates, line and site. A reviewer can move from that lot to its specifications and exception records before deciding on release.
Start with one tablet product and a representative specification. Create a batch with a quantity in Tablets, a line, site and dates. Record a passing test result and an exception result. Link a deviation to the batch and carry its CAPA through an effectiveness check. Review the batch with the product specification open, then record a release decision with rationale. Record the Release decision before marking the reviewed batch Approved, then reconcile the posting receipt with the batch status.
During setup, agree who maintains product strength and storage condition, which specification version applies and what the team considers complete test evidence. Keep changes to the product or specification visible through change controls. A change marked Approved and one marked Implemented represent different moments, so the release reviewer should inspect the current state before deciding.
Features to start with
Roles on the team
- Production Manager
- Owns the batch record and follows its manufacturing status.
- QC Analyst
- Records test outcomes and reviews the applicable product specification.
- QA Manager
- Investigates quality issues, owns corrective actions and reviews controlled changes.
Set up ERP + Quality for Pharma your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.