⚗️ Chemical & Pharma ERP: Formula management

The right formula, at the right strength, in every batch

Keep master formulas under version control, adjust quantities to each lot's assay and moisture, scale from lab to commercial batches, allow only approved substitutes and track yield stage by stage. Every change is signed and logged.

  • Schedule Mready records
  • Part 11e-signatures and audit trail
  • Every lotpotency adjusted
Master formula: Metformin 500 mg tabletsDemo, v2.0

Batch size (tablets)

API lot from stores

IngredientFormulaTo weigh
  • Metformin HCl00
  • Microcrystalline cellulose PH10200
  • Povidone K3000
  • Croscarmellose sodium00
  • Colloidal silicon dioxide00
  • Magnesium stearate00

Formula anatomy

Every ingredient has a job, a grade and a limit

Pick a layer to see what the ingredient does, the grade the formula asks for, who can supply it and what gets checked. Layers show the demo tablet's six ingredients.

Version control

Only the effective version reaches the floor

Each change goes through change control and gets signed before it takes effect. Pick a version to see what changed and who approved it.

Scale-up

One formula, from 1,000 tablets to 3 lakh

Move the slider. Quantities scale, and the system picks the granulator whose working capacity fits the batch. Demo assumes a bulk density of 0.5 g/mL and a 30 to 75% fill window, which your team sets.

2,00,000 tablets
Batch weight140 kg
Granule volume280 L
Equipment600 L

    Material substitution

    Stores can only issue what the formula allows

    A material runs short. Pick it and see how the rules decide: allowed, allowed with extra checks, change control or blocked.

    1. 1Request
    2. 2Rule check
    3. 3Outcome
    Yield

    Theoretical against actual, stage by stage

    The demo formula's theoretical yield is 140 kg for 2 lakh tablets, with limits of 97 to 100%. Pick a batch to see where material went.

    Actual yield0 kg
    Yield0%
    Limits97–100%

    How it works

    From your files to controlled formulas

    Six steps to move formulas into one system.

    1. Step 1Load your formulasIngredients, quantities, grades and limits from your current files.
    2. Step 2Set approvalsWho drafts, reviews and approves, with e-signatures.
    3. Step 3Link materialsSpecifications, approved suppliers and substitutes.
    4. Step 4Add batch sizesLab, pilot and commercial sizes with equipment limits.
    5. Step 5Connect the floorEffective versions feed dispensing and batch records.
    6. Step 6Watch yieldLimits, losses and investigations, batch by batch.
    What it changes

    Results QA, production and R&D notice

    What changes once formulas run on one controlled system.

    Right strength, every lot

    Quantities follow each lot's assay instead of a fixed number.

    No wrong-version batches

    Only the effective, approved version can be issued.

    Substitutes under control

    Stores can only issue what the formula allows.

    Losses you can see

    Yield by stage shows where material goes.

    Who it's for

    Built for makers whose product is a formula

    From a single tablet line to a multi-site contract manufacturer.

    • Generic tablet and capsule makers
    • Liquid, syrup and injectable plants
    • Contract manufacturers running client formulas
    • API and bulk drug producers
    • Specialty and agro-chemical blenders
    • Cosmetics and nutraceutical brands
    Chemical & Pharma ERP

    Other modules in the suite

    One integrated system.

    FAQ

    Formula management questions

    Answers for QA heads, production managers and R&D teams.

    What is formula management software?

    It holds your master formulas under control: every ingredient, grade, quantity and limit for each product, strength and batch size. It manages versions and approvals, adjusts quantities for each lot's potency, controls substitutes and feeds the approved formula into dispensing and batch records.

    How does potency adjustment work?

    The active quantity is divided by the lot's assay on an as-is basis. If assay is reported on a dried basis, it's first converted using loss on drying: as-is assay = dried-basis assay × (1 − LOD). The extra active is usually taken out of the filler so the tablet or batch weight stays the same. Your validated method decides the exact rule, and the system applies it the same way every time.

    Can it stop the wrong formula version being used?

    Yes. Each version moves from draft to review, approval and effective. Only the effective version can be issued to production, and the batch record shows which version was used.

    Does it support electronic signatures and audit trails?

    Yes. Approvals use e-signatures linked to the record, and every change is logged with who, when, what and why, in line with 21 CFR Part 11 and EU GMP Annex 11 expectations.

    How are material substitutes handled?

    Each material can have approved alternates with conditions, such as extra testing for a new supplier. Anything that isn't approved is either blocked or sent through change control.

    Can it scale a formula to different batch sizes?

    Yes. One formula can carry lab, pilot and commercial batch sizes. Quantities scale automatically and the system checks the batch against the working capacity of the equipment you pick.

    Does it track theoretical and actual yield?

    Yes. Each formula carries a theoretical yield and limits. Actual yield is recorded by stage, and a batch outside the limits opens an investigation.

    Is it only for pharma?

    No. The same controls work for specialty chemicals, agro-chemicals, cosmetics, nutraceuticals and paints, where formulas, grades and hazard data matter just as much.

    How long does implementation take?

    As an estimate, 6 to 10 weeks for one plant, depending on how many formulas you have and how clean the current files are. We usually start with a few high-volume products and add the rest in waves.

    Get In Touch

    Ready to control every formula and every lot?

    Tell us your products, batch sizes and how you keep formulas today. We reply within 4 business hours and can demo with one of your own formulas.

    ⏰
    Response TimeWithin 4 business hours (your timezone)
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