Build a pharmaceutical plant system around your batch records, your lots and your release steps.
A pharmaceutical plant runs on the batch record. It lists the materials weighed, the equipment used, the steps signed and the tests passed.
Plants usually keep that record on paper, with stock in one package and quality in a folder of spreadsheets. Reconciling a batch means walking between three places.
A system built at GullySystem would put the batch and the lot at the centre. Raw material, process, testing, release and dispatch would all point back to them.
Drug makers a system can be built for.
A plant making active ingredients in reactors and a tablet unit running compression lines hold different records. A contract manufacturer holds those records for each client separately. The build follows the kind of plant you run.
- Active ingredient manufacturers
- Bulk drug and intermediate units
- Tablet manufacturing units
- Capsule filling units
- Liquid oral and syrup plants
- Ointment and cream plants
- Injectable and ampoule plants
- Contract pharma manufacturers
- Private-label drug manufacturers
- Nutraceutical and supplement makers
- Herbal and traditional medicine makers
- Pharma packaging manufacturers
- Blister and foil converters
- Plants with several dosage forms
The modules, and what each one covers.
Nothing here is a fixed package. Each module is built, left out or changed to match how your organisation already works.
The material master
Every raw material, excipient and packing item is described once, and every lot received is tied to that description.
- Material code and grade
- Approved vendors per material
- Pharmacopoeia reference
- Storage condition
- Retest and expiry rule
- Controlled substance flag
- Potency and assay adjustment
- Specification version
- Alternate materials
- Quarantine on receipt
The product and formula record
A product carries its formula, its batch size and its manufacturing method, each with a version.
- Product and strength
- Master formula by version
- Batch size range
- Overage rules
- Manufacturing method steps
- In-process limits
- Packing specification
- Shelf life
- Marketing authorisation holder
- Change history of the formula
Vendor qualification and incoming material
Quality teams qualify suppliers. Stores teams receive against purchase orders.
- Vendor audit schedule
- Approved vendor list
- Purchase order
- Gate and security entry
- Container count and condition
- Sampling plan
- Certificate of analysis capture
- Quarantine, approved and rejected status
- Label printing per container
- Rejection and return to vendor
Sampling and the quality control laboratory
Analysts receive samples with a test plan attached and record each result against a limit.
- Sample request from stores
- Test plan from the specification
- Analyst assignment
- Instrument allotted
- Raw data and result entry
- Out-of-specification investigation
- Reagent and standard log
- Retention sample store
- Certificate of analysis issued
- Release or rejection of the lot
Dispensing and weighing
Weighing is where the formula meets the floor, so each weighment is checked against the batch record.
- Dispensing against a batch
- Container and lot selection by first expiry
- Balance used and its calibration
- Gross, tare and net weight
- Second person verification
- Label for each dispensed item
- Returned and balance material
- Dispensing booth cleaning record
The batch manufacturing record
Each step is signed as it happens and each deviation is recorded where it occurred.
- Batch number and issue
- Line clearance before start
- Equipment and room used
- Step-wise entries with time
- Operator and checker signature
- Yield at each stage
- Deviation raised from the step
- Intermediate holding time
- Reconciliation of materials
- Review before packing
The record has the same sections on paper and on a screen. What changes is that a missed entry stops the next step instead of being found at review.
Process stages
The stages differ by dosage form, and the system carries only those the plant runs.
- Dispensing
- Granulation or reaction
- Drying
- Blending
- Compression, filling or crystallisation
- Coating or milling
- Packing
- Quarantine and release
Equipment, calibration and cleaning
An instrument or a vessel is used only while it is calibrated and clean, and the log says so.
- Equipment register
- Calibration schedule and certificates
- Preventive maintenance plan
- Status labels: clean, in use, to be cleaned
- Cleaning type and verification
- Product used last on the equipment
- Breakdown record
- Change control for modification
- Validation status
Deviations, change control and investigations
Quality assurance teams own these records and see them across batches rather than one at a time.
- Deviation entry from any step
- Impact assessment
- Root cause and corrective action
- Preventive action follow-up
- Change request and approvals
- Out-of-trend watch
- Customer complaint link
- Closure with reviewer sign-off
- Repeat deviations by equipment
Batch review and release
A batch is released by the person authorised to release it, after the record is read in full.
- Batch record review checklist
- Open deviations blocking release
- Test results attached
- Packaging reconciliation
- Yield within limits
- Qualified person decision
- Release status by lot
- Rework and reprocessing record
Stability studies
Samples are put on stability and pulled on a schedule, so the pull dates cannot be forgotten.
- Study protocol
- Chamber and condition
- Sample placement
- Pull-point calendar
- Test at each pull point
- Trend of results
- Shelf life support
- Out-of-limit alert
Packaging, labelling and serialisation
Label and carton control is its own discipline, with its own reconciliation.
- Printed material master
- Label approval
- Issue against a batch
- Overprinting of batch and expiry
- Line clearance
- Reconciliation of issued, used and destroyed
- Destruction record
- Serial numbers for cartons where the market needs them
Warehouse and finished goods
Stock moves by lot and status, so a quarantined lot cannot be picked.
- Location and bin
- First expiry, first out
- Quarantine and approved zones
- Temperature-controlled areas
- Cycle counts
- Dispatch against order
- Near-expiry list
- Recall reach by lot
Contract manufacturing for clients
Contract plants run the same lines for several brand owners, each with its own paperwork.
- Client master
- Quality agreement terms
- Client-owned materials
- Batch records per client
- Client approval of release
- Technical transfer record
- Billing on conversion work
- Client-wise reports
Dispatch, invoicing and returns
Invoices follow the lot actually sent, and returns come back against the same lot.
- Sales order or client instruction
- Pick by lot
- Tax invoice
- Transport and cold chain record
- Goods return
- Return inspection
- Distributor ledger
- Expiry-linked credit note
One connected workflow, end to end.
Every stage below can sit in one system, so nobody re-enters what the last stage already captured.
- Material receipt
- Sampling and testing
- Dispensing
- Manufacturing
- In-process checks
- Packing
- Batch review
- Quality release
- Warehouse
- Dispatch
You do not have to replace everything at once.
Each phase is usable on its own, so the system earns its place before the next part is built.
- 1
Materials and the quality laboratory
The material master, vendor records, sampling, test results and lot status. Stores and the laboratory share one list.
- 2
Batches and equipment
The product formula, dispensing, the batch record, equipment logs and deviations raised from the floor.
- 3
Release, stock and dispatch
Batch review, release decisions, packaging reconciliation, warehouse by lot and invoices that follow the lot.
- 4
Studies, clients and reporting
Stability schedules, contract client views, trend reports and links to the machines that already produce data.
How a build actually runs.
- 01
Walk the line
We follow one batch from the stores window to the dispatch gate, with the quality team and the production head present.
- 02
Read your records
Your batch record, your procedure list and your deviation register show which steps are mandatory and which are habit.
- 03
Design for the floor
Screens for an operator wearing gloves and for an analyst entering a result are different, so they are drawn separately.
- 04
Build the lot first
Material receipt and lot status come first, because every later record points at them.
- 05
Run beside paper
One product runs on the new record while paper continues beside it. The two are compared line by line before the paper stops.
- 06
Validate with you
Your quality team decides what documented validation the system needs, and the build supplies the evidence it asks for.
- 07
Extend
More products, more dosage forms and more sites are added once the first has settled.
What you bring, and when.
The build moves at the speed of the answers. These are the things we ask for, in the order we ask.
- 01
SOPs, master formulas and batch records
Send approved SOPs, master formulas, completed batch records, QC worksheets and deviation reports. Equipment logbooks help. Design follows the paperwork already in use.
- 02
Production, QC and QA representatives
Each department names someone who knows the routine. They compare screens with real batches. The head of quality rules if departments read a procedure differently.
- 03
Specifications, release criteria and change steps
Material and product specifications, release criteria, deviation classes and change control steps are confirmed ahead of those modules. Vendor and equipment masters follow. Reviews take place at every demonstration.
- 04
Opening stock and validation papers
Approved vendors, material stock by lot and open batches move across at go-live. The validation team prepares test scripts in parallel. The quality head gives the release.
Systems we can put together for you.
- Batch manufacturing record systems
- Raw material and packing material stock systems
- Quality control laboratory systems
- Vendor qualification and approval tools
- Deviation and change control registers
- Equipment calibration and maintenance trackers
- Stability study schedulers
- Label and carton reconciliation tools
- Quarantine and release workflows
- Warehouse and dispatch by lot
- Contract manufacturing client portals
- Distributor ordering and ledger systems
- Production planning boards
- Management dashboards
- Multi-plant pharmaceutical platforms
Questions owners ask before starting.
What is custom pharmaceutical manufacturing software?
It is a system written for one plant’s products, formulas, batch records and release steps. A general factory package rarely models quarantine status or batch review the way a plant needs them.
Can it replace our paper batch record?
It can, step by step. Which entries need a second signature and which can be automatic is decided with your quality team.
Will it be validated?
That is your quality unit’s decision. We can supply the specifications, test evidence and change records it asks for, and the scope is agreed during implementation.
Does it follow a particular regulator’s rules?
Not by name. The rules you work under are written into the design from your own procedures, and we do not claim a regulatory standard on behalf of the software.
Can it read results from laboratory instruments?
Where an instrument can export a file or connect over a port, results can be brought in. Each instrument is checked during the design stage.
We make for several brand owners. Can records stay separate?
Yes. Each client has its own products, batches, approvals and reports, while the plant sees the whole schedule.
Can we start with only the warehouse and lots?
Yes. Lot-wise stock and quarantine status are often the first piece, and the batch record is added on top.
What becomes of the records we already hold?
Material, vendor and open stock lists are carried across. Closed batch records stay in their original form unless you ask for them to be scanned and linked.
How we work with this trade.
Ready products for this work.
If one of these fits, it is cheaper and faster than building from scratch. We will say so.
Build a plant system that follows your lots.
A recall question is answered by the lot. Which materials went in, which batches came out and which customers received them should be one search.
Send one product’s batch record and your quarantine procedure. The written reply covers how that record would run on a screen and what the first release would include.
Tell us how your pharmaceutical manufacturing companies runs today.
We will tell you what can be digitised, what can be connected, what is worth automating, and what you should leave alone.
What happens after you share your requirements
- A senior engineer reads your answers. Nobody phones first.
- Within one business day you get a written note: what we understood, what we would start with, and the questions we still have.
- If it fits, a proposal follows with the order of work, what we need from you and what you receive at each step.
- No call is booked and nothing is paid until you have read the note. Your details stay with us.
Start with your requirements
Seven short steps that tell us what you need. A senior engineer reads them before anyone gets in touch.
Share your requirements