Pharmaceutical Manufacturing
Pharmaceutical Manufacturing: production orders and BOM, stock and warehouse, quality and reporting.
Challenges
- The batch manufacturing record is kept on paper, so batch release drags on for days.
- Raw material quarantine status is invisible in stock, so unapproved material can reach production.
- Expiry is tracked at product level, so batch-level expiry dates slip through.
- In recall drills, working out which batch went where is done by hand.
Workflows
From raw material receipt to production
- Raw material is placed in quarantine with its batch number and certificate of analysis.
- After quality control approval the stock moves to released status.
- The production order is tracked through dispensing, mixing and filling operations.
From quality control to shipment
- The batch file — production records and analyses — is completed.
- With the release approval the batch becomes sellable.
- Shipment is made with batch and expiry details, and a distribution record is kept.
Documents
- Raw material certificate of analysis
- Batch manufacturing record
- Batch release approval record
- Delivery note with batch and expiry details
Reports
- Quarantine and released stock status
- Expiry and shelf life by batch
- Deviation and corrective action report
- Distribution breakdown — which batch went to whom
Metrics
- Batch release lead time
- Batch rejection rate
- Share of stock nearing expiry
- Recall drill turnaround time
Compliance
- Good manufacturing practice (GMP) and marketing authorisation requirements
- Qualified person (QP) release approval records
- Medicine track-and-trace notifications and recall procedure
Glossary
- Batch file
- The batch record that brings production and quality documentation together in one place
- Quarantine
- A stock status awaiting approval and closed to use
- Batch release
- The quality approval step that makes a batch sellable
- Expiry date
- The batch-level expiry date field
FAQ
Can I keep the batch file digitally?
Yes — production records, analyses and approvals converge on the batch record and are linked to the document archive.
Can I prevent unapproved raw material from being used?
Yes — quarantined stock cannot be issued to a production order and becomes usable only after quality approval.
Can I track expiry at batch level?
Yes — the expiry date is a batch field and the approaching-expiry report raises a warning.
In a recall, can I produce the distribution list quickly?
Yes — the batch number is linked to shipment and customer records, so the list is produced instantly.
Can I record deviations?
Yes — a deviation record is linked to a corrective action task and its closure is tracked.
