Synthesis stages, batch records, intermediates and deviations for plants making active pharmaceutical ingredients.
Run an API plant, one that makes active pharmaceutical ingredients, from starting materials to the sealed drum. The route and stage master, batch manufacturing records, intermediate and final lot genealogy, laboratory results, equipment cleaning, deviations and retest dates sit together. Operators post charges and readings at the reactor. Analysts post results against each sample, and quality staff review the full batch before release.
- Products, routes and stages keyed in as the plant uses them
- Open batches, lots and customers migrated
- Review, deviation and release steps defined by your quality head
Plants making active pharmaceutical ingredients keep synthesis routes, batch records, intermediate genealogy, laboratory results, equipment cleaning, deviations and dispatch in API Manufacturer Management Software from GullySystem. Each final lot traces back to its starting materials. Your quality unit keeps authority over review and release.
What goes wrong before the software.
How the work flows through it, step by step.
- 1
Starting material receipt
Materials arrive against a purchase order, are sampled and are held until released by quality staff.
- 2
Stage charge and reaction
Charges, temperatures, pressures and hold times are logged against the stage and the reactor used.
- 3
Isolation and drying
Filtration, centrifuging and drying are recorded with yields and samples drawn.
- 4
Test and review
Results are posted against the specification. The batch record is reviewed with its deviations before the next stage or release.
- 5
Mill, blend and pack
The final powder is milled, blended and packed in sealed drums, each with a recorded seal number.
- 6
Release and dispatch
The lot is released, a certificate is produced and the load is shipped with the retest date visible.
What is inside.
Every module can be switched on, left out or changed to match how your team already works.
The business modules it is built from.
Each one is also available on its own, or inside a system built for you.
- Bill of Materials
Each route lists starting materials, solvents and equipment per stage, so a batch starts from the correct revision of the process.
- Batch and Serial Tracking
Final lots link back through intermediates and any reprocessed material to the supplier lots of the starting materials.
- Quality Control
Assay, impurity and solvent results are compared with the specification, and an out-of-limit sample holds the lot until quality staff decide what happens to it.
- Workflow and Approvals
A deviation is raised against a stage, routed to named reviewers and kept visible on the batch until it is closed.
- Audit Trail
Changes to routes, specifications and equipment records are logged with user and time, and take effect from a stated batch.
- Work Order Management
Each batch runs as an ordered set of stage tasks, with parameters, yields and sign-offs captured as the stage is completed.
- Goods Receipt (GRN)
Starting materials are received against purchase orders and held in quarantine until sampled and released.
- Stock Tracking and Alerts
Final lots show their retest dates, and stock past retest is flagged so dispatch holds are not applied by hand.
How we would put it in.
Setup, data migration, integrations and anything built on top.
One system, each person sees their part.
For production heads
Follow batches in progress, equipment in use, yields by stage and open deviations.
For operators
Post charges and readings at the reactor on a tablet, with the stage instructions in view. Paper stays in the office.
For analysts
Post results against the sample and compare them with the specification.
For quality staff
Review each batch record, its deviations and test results before release.
The numbers the owner asks for.
- Batches by stage and product
- Yield by stage across campaigns
- Open deviations by age and stage
- Intermediate lots and the final lots they fed
- Equipment use and cleaning between products
- Retest dates by lot
- Dispatch by customer with certificate numbers
Who this is built for.
- Makers of bulk active ingredients for finished-dose manufacturers
- Plants running multi-step synthesis in campaigns
- Producers of intermediates sold to other API makers
- Companies that supply APIs to contract and generic manufacturers
- Plants running fermentation or extraction before purification
When it is not the right choice.
- A tablet or capsule maker will find Pharmaceutical Manufacturer Management Software closer.
- A trader that only buys and resells active ingredients needs stock and invoicing, not a batch record.
Adapted to your business before it goes live.
You are not handed a login and left to it. The product is set up around your records, your people and the tools you already use.
Works alongside
- Laboratory instruments by file import
- Barcode and label printers
- Weighing scales
- Accounting export
Questions owners ask before a demo.
What does a batch record contain?
Charges, parameters, hold times, yields, samples, equipment used, deviations and each reviewer’s sign-off, for every stage of the batch.
Can a reprocessed lot be shown in the genealogy?
Yes. Rework steps are recorded with the lot and quantity. The final lot shows what was blended in.
How does it handle campaign cleaning?
Each campaign change logs a cleaning record against the equipment, with the swab or rinse results, before the next batch can start.
Is it validated?
Validation is the customer’s responsibility and is planned with your own quality staff. We provide the system and documentation to support it.
Can we trace a customer complaint to the starting material?
Yes. Start with the lot shipped and follow it back through intermediates to the supplier lot.
How are approvals recorded?
Reviews are recorded by named users with date and time. Signature rules follow what your quality head signs off.
How is the demonstration arranged?
A session using one of your routes is run first. The proposal depends on products, plants and users.
Can we export the batch data?
Batch, lot, test and deviation records export to spreadsheet and document files, in a format written into the agreement.
Wondering what it would cost? Share your requirements and an engineer will come back with a scope.
Businesses that use this.
See API Manufacturer Management Software with your own data.
Tell us how you run things today. We’ll show you the parts that matter to you and say plainly what would need changing.
- No obligation
- A reply within one business day
- Your details stay private
Start with your requirements
Seven short steps that tell us what you need. An engineer reads them before getting in touch.
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