ProductionMaster formula and packing records, formula rules for potency and q.s., batch records checked against their master, and batch splitting.
Master records that know how pharma formulas really work, and batch records the system checks against them - so the batch on the floor is the batch that was approved.
Production, in detail
Master records
The master formula and master packing record for each product, approved before use.
- The formula kept as the record's own lines
- Alternate materials allowed per line
- The author cannot approve their own master record
Formula quantity rules
The quantities pharma actually dispenses, not just what the label says.
- Potency corrected: dispensed by the lot's potency from its approved certificate
- q.s.: the filler gives back what the active needed extra
- Evaporates: solvents that do not stay in the product
- Worked out per batch size
Batch records
Batch manufacturing and packing records drawn from the master.
- Batch record checked against its master - differences listed
- Materials dispensed by lot, with potency
- Approved by QA before release
Batch splitting
One released bulk packed as several new batches.
- Bulk divided into new batches with their own numbers
- Quantities and history carried to each batch
Hold times enforced
A bulk that has waited too long does not reach packing.
- Established hold from the hold-time study
- Past its hold, the bulk is refused at dispensing and verification
- Unless a deviation names the batch
Step by step
- MasterMFR and MPR approved
- PlanBatch created from the master
- DispenseMaterials issued by potency
- ManufactureBatch record completed
- PackWithin the established hold time
- ReleaseQA reviews and releases
Controls built in
- Two-person approval of master records
- An open deviation blocks batch release
- Every dispensed lot traceable to its receipt and certificate
Related modules
Warehouse and Stores
Gate entry to dispensing: goods receipt into quarantine, stock moved by QC status, racks and areas, and material codes by grade and manufacturer.
Learn more QMSQuality Management
Quality control and quality assurance in one place: protocols, sampling, results, deviations, CAPA, hold-time studies and water testing.
Learn more DMSDocument Management
Controlled documents and SOPs: versions, review and approval with e-signatures, editing in the browser, controlled printing and an append-only audit trail.
Learn moreSee it with your own process
Open the live demo and look around, or talk to us about your plant.