Take the tour Book a demo

API manufacturingIntermediates · recovery · genealogy

API manufacturing software that controls every recovered lot.

Swat iQua Suite runs bulk drug manufacturing on the same electronic batch record engine as the rest of your plant — and adds what API sites need most: controlled intermediates, one reuse gate for recovered solvents and materials, mass balance checks and lot genealogy from raw material to shipment.

  • Recovery reuse gate with mass balance
  • Intermediate lots with QC and QA disposition
  • Reaction-to-filtration stage types in the eBMR
  • Forward and backward lot genealogy
Book a free demo See the eBMR
Electronic batch record showing process steps, parameters and verification status

Solvent recovery and reprocessing

Recovered solvents and materials, reused only when every rule passes.

This is where most bulk drug manufacturing software stops short — and where Swat iQua Suite puts its strongest controls.

In API synthesis, recovered solvents, mother liquors and reprocessed materials are part of normal economics. They are also a recurring inspection topic: regulators expect recovery to follow approved procedures, recovered material to meet suitable standards before it is reused, and the full history to be traceable. Logbooks and spreadsheets rarely prove all three.

Versioned recovery streams

Each recovery stream is defined once and approved under three-way segregation of duties — preparer, reviewer and approver are three different people — with an electronic signature. A revision supersedes the previous version, so every recovery operation records which approved rules applied at the time.

One reuse gate, every time

A recovered lot can only be reserved for reuse when Swat iQua Suite confirms all of the following in a single server-side check:

  • QA has approved the lot, QC has passed it, and it has been assessed and approved for reuse;
  • its mass balance passed;
  • it is still within the maximum number of recovery cycles;
  • the batch stays within the maximum recovered fraction and minimum fresh make-up set on the formula line;
  • the reuse scope is allowed — same process, cross process or final step;
  • enough quantity is available.

If any rule fails, the lot cannot be reserved — there is no workaround on the shop floor. A site-level switch also lets QA stop all reuse at once while an issue is investigated.

Mass balance with consequences

Every recovery operation calculates input plus fresh material, minus recovered material, waste and loss, against an acceptance limit. An out-of-limit result raises a deviation automatically and blocks reuse of that lot until the deviation is dealt with.

Reuse rules live on the master formula

For each bill-of-materials line, the approved formula states whether the material must be fresh only, may be blended with recovered material, or may be recovered only — with maximum fractions and cycle limits. Changing a rule goes through the formula’s own approval workflow, and the reuse gate follows the approved version.

Recovered lots move through Quarantine → Under Test → Passed or Failed, and each reuse moves through Reserved → Dispensed → Verified → Consumed — every step in the audit trail.

API intermediate control

Every isolated intermediate has a parent, a status and a QA decision.

Intermediates between synthesis steps are tracked as lots in their own right, with QC results and QA disposition — not as notes in a batch record.

  1. eBMRCrystallisation

    Intermediate isolated

    A lot number is minted on isolation and linked to the parent batch and the stage that produced it.

    Isolated

  2. QCResult e-signed

    QC result recorded

    The QC result is recorded against the intermediate lot with an electronic signature.

    QC complete

  3. QADisposer ≠ isolator

    QA disposition

    Refused until QC is complete; the person who isolated the lot cannot disposition it.

    Released

  4. Next stageConsumed

    Used downstream

    The released intermediate is consumed by the next batch, so genealogy stays unbroken.

    Consumed

Putting a lot on hold, or releasing it from hold, needs a recorded reason.

API batch execution

Synthesis steps on a proven electronic batch record.

API batches run on the same eBMR engine used across Swat iQua Suite, with stage types built for chemistry: reaction, addition, extraction, distillation, solvent swap, crystallisation and filtration, plus drying, milling and blending.

  • Version-locked masters — each batch snapshots the approved product, formula, process and specification versions.
  • Hold points — a step cannot start while an earlier hold point or verification step is still open.
  • CPP limits — an out-of-limit reading raises a deviation; corrections supersede and never overwrite.
  • Training interlock — operators must be trained on the SOPs linked to the step.
  • Yield classified — against the formula’s yield window at an e-signed close.
eBMR software
Batch record step list with recorded parameters and verification signatures

Around the batch

The rest of the API plant, on the same records.

  • Qualified sources & receipt

    Materials are ordered only from approved supplier list sources and received into quarantine. Identity is always tested; reduced testing is decided per manufacturer site.

    Approved supplier list

  • In-house QC for APIs

    Raw material, intermediate, API, recovery and cleaning-validation samples tested against the effective specification, with limits frozen at assignment.

    In-house QC testing

  • Verified dispensing

    Only QA-released lots, calibrated critical scales and a second-person verification with e-signature.

    Dispensing & weighing

  • Evidence-based release

    QA releases only when the batch record, QC results, CoA, deviations and genealogy checks are complete — and the person who ran the batch cannot release it.

    Batch release

  • Genealogy & recall

    Trace any lot back to its raw-material lots and forward to every customer shipment; a recall resolves the affected lots and customers automatically.

    Traceability & recall

  • Deviation & CAPA

    Deviations raised by CPP limits and mass balance failures flow into one CAPA register, tracked to verified closure.

    Deviation management

Customer story

API manufacturers trace any batch in one click.

“Any batch, traced in one click.”

In API manufacturing, traceability is everything. Today we follow any batch back to its raw-material lots and forward to every shipment in seconds. Revised Schedule M no longer feels like a deadline — it feels like the way we already work.

Norvium Healthcare Pvt. Ltd.India · API manufacturing

Compliance

Built around what API inspectors ask to see.

ICH Q7 is the GMP guide most regulators apply to active pharmaceutical ingredients. In broad terms it expects defined and controlled processes, an independent quality unit, intermediates tested and released under quality-unit authority, solvent and material recovery under approved procedures, complete batch records and full traceability from starting materials to the finished API. Swat iQua Suite maps each expectation to a control the system enforces:

  • Independent quality unit — segregation of duties: the person who isolated a lot or ran a batch cannot disposition or release it.
  • Intermediate release — QA disposition is refused until QC is complete, and it is e-signed.
  • Recovery and reprocessing — versioned recovery streams, a single reuse gate and mass balance checks that raise deviations.
  • Batch records — an Executed Batch Record PDF with parameters (including corrections), signers, deviations, attachments and the full audit trail.
  • Starting materials — approved sources only, quarantine on receipt and identity testing for every incoming lot.
  • Traceability — one-click forward and backward genealogy across material lots, dispensing, batches, intermediates and shipments.

For Indian manufacturers, Revised Schedule M now applies to every manufacturer, large or small, and export customers bring their own regulators’ expectations. Swat iQua Suite is designed to comply with 21 CFR Part 11, EU GMP Annex 11, WHO GMP and Revised Schedule M, following ALCOA+ data-integrity principles and a GAMP 5 risk-based validation approach — so the same records serve every market you supply.

Keep exploring

Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

Is API manufacturing a separate product?

No. API manufacturing in Swat iQua Suite runs on the same eBMR engine as other batches, with API stage types, intermediate control and recovery and reprocessing added. Your QMS, QC lab, warehouse and release records stay on the same platform.

How does the system decide whether a recovered solvent can be reused?

Through one reuse gate. A recovered lot is admitted only if QA has approved it, QC has passed it, it has been assessed for reuse, its mass balance passed, it is within the maximum recovery cycles and recovered fraction, the reuse scope is allowed and quantity is available.

What happens when a mass balance fails?

An out-of-limit mass balance raises a deviation automatically and blocks reuse of that lot. The deviation then follows your normal investigation and CAPA workflow.

Can we trace an API batch back to raw materials?

Yes. Genealogy links material lots, dispensing, batches, intermediates, packaging and shipments, so any lot can be traced backward to raw-material lots and forward to every customer shipment.

Does it support Revised Schedule M?

Swat iQua Suite is designed to comply with Revised Schedule M, alongside 21 CFR Part 11, EU GMP Annex 11 and WHO GMP. Compliance itself depends on your procedures and validation; the software provides the controls and records.

Ready to see Swat iQua Suite in action?

Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.

Download the brochure →