Industries · Herbal medicinal products
Herbal medicinal products
For sites that receive plant material, dry and prepare it, extract it, and test and release the result.
The path of one batch, in four stages.
- 1Incoming material and storage5 steps · 3 with limits
- 2Preparing the plant4 steps · all available
- 3Extraction3 steps · 3 with limits
- 4Testing and release5 steps · 2 with limits
What you can run from start to finish today
From receipt to release on the screens, for plant material that is dried, or extracted with carbon dioxide or by mechanical separation.
Where it stops
- Stops the process. Entering the residual solvent result is not available on the screens yet. So a batch extracted with an organic solvent, such as ethanol, cannot be released from the screens.
- Not on the screens yet: Run an identity test on every batch received; Qualify equipment through URS, IQ, OQ, PQ; Close the balance on the active substance.
- Quarantine status recorded. Material in quarantine can still be used in production: MALUTI does not yet stop a run from consuming raw material that has not passed its own tests. Only the finished batch is held back at release.
- Hold and monitor storage conditions. A reading outside its limit is shown on the screen, but it is not yet recorded as an alarm by itself: someone has to see it and act.
What this page says about MALUTI was checked against the product’s code on 30 September 2026. It has not yet been walked through from start to finish on a test site.
Incoming material and storage
1Supplier approval under GACPBuilt in MALUTIOpenClose
Register counterparties and score suppliers
Built in MALUTIYour team
Your qualified person registers each supplier with the licence it works under.
In MALUTI
The supplier: kind, name, licence number, issuing authority, expiry date, and certificates kept with a fingerprint, so any later change to the file shows. Every change stays visible.
Checked by MALUTI
- Only the qualified person can register or change a supplier.
- A licence without the authority that issued it is refused.
Boundaries
- Entered by hand: the supplier score and the judgement behind it.
Technical detail
- Ledger operations RegisterCounterparty, AmendCounterparty, SetCounterpartyCertificate; the role check is in the ledger, not the screen.
Audit suppliers and keep the reports
Done by the site, recorded in MALUTIYour team
Your site or its auditor audits the supplier and writes the report.
In MALUTI
The audit against that supplier: date, outcome, the report kept with a fingerprint, so any later change to the file shows, and when the next audit is due.
Checked by MALUTI
- Only the qualified person can record an audit.
- An audit without its date, its outcome or its report is refused.
Boundaries
- MALUTI does not audit suppliers; it keeps the record that the audit took place and what it found.
- Entered by hand: the audit itself and its outcome.
Technical detail
- Ledger operation RecordSupplierAudit.
Regulatory context
The starting material comes from a supplier under GACP. Only herbal starting material made in accordance with GMP and the marketing authorisation, from suppliers in compliance with good agricultural and collection practice, with the audits of them documented.
2Goods-in examination and identityAvailable with limitsOpenCloseRecording the identity test of a received batch is not available on the screens yet.
A grower declares a delivery
Built in MALUTIYour team
The grower or supplier declares a delivery before it arrives.
In MALUTI
The declared delivery: supplier, strain, plot of origin, gross and tare weight, wet or dry, and the plant parts it contains.
Checked by MALUTI
- A delivery without a supplier, a strain or the plot it came from is refused.
- A tare that is not less than the gross weight is refused.
Boundaries
- Anyone with access can declare a delivery; the check comes at goods-in.
- Entered by hand: the declared figures come from the supplier.
Technical detail
- Ledger operation DeclareDelivery; no role restriction in the ledger.
Examine each container: labels, damage, broken seals
Built in MALUTIYour team
Goods-in staff examine every container: label, damage, broken seals.
In MALUTI
The examination: number of containers, the name as printed on the supplier label, and a plain answer to each of the four points Part II 7.20 names.
Checked by MALUTI
- A delivery cannot be accepted until it has been examined.
- Only goods-in operators and the qualified person can accept a delivery.
Boundaries
- Entered by hand: what the person saw on the containers.
Technical detail
- Ledger operations ExamineDelivery and AcceptDelivery; acceptance refuses an unexamined delivery.
Run an identity test on every batch received
Not on the screens yetRecording the identity test of a received batch is not available on the screens yet.
Your team
The laboratory tests the identity of every batch received, or your site relies on the supplier's certificate where the supplier has earned it.
In MALUTI
The identity test of the batch: your own test or the supplier's certificate, and the verdict.
Checked by MALUTI
- A supplier certificate is accepted instead of a test only when that supplier has enough full analyses on record.
Boundaries
- An identity test is not required before the material is used, or before the finished batch is released.
- Entered by hand: the test itself is the laboratory's.
Technical detail
- Ledger operation RecordIdentityTest exists behind POST /api/module1/batch/:id/identity; no page calls it.
Regulatory context
Every container examined, every batch identified. Each container examined on arrival for labels, damage and broken seals, and an identity test run on every batch received.
3Specification for the plant materialBuilt in MALUTIOpenClose
Approve a specification, every limit naming its method
Built in MALUTIYour team
Your qualified person approves the specification for the plant material.
In MALUTI
The specification with its version and its source (monograph, guideline or regulation); every limit with its unit and test method. Each batch is held to a named specification.
Checked by MALUTI
- Only the qualified person can approve a specification or hold a batch to one.
- A limit without a test method or a unit, or with minimum above maximum, is refused.
- A released batch cannot be put under a new specification.
Boundaries
- Entered by hand: the limits themselves are your site's decision.
Technical detail
- Ledger operations DefineSpecification and HoldToSpecification.
Regulatory context
The specification names the plant, not only the limits. The binomial scientific name, the source of the plant, the part used, the drying system, identity tests, water content, assay of markers, pesticides, fungal and microbial limits with aflatoxins, toxic metals and foreign materials.
4Quarantine and separate storageAvailable with limitsOpenCloseMaterial in quarantine can still be used in production.
Quarantine status recorded
Available with limitsMaterial in quarantine can still be used in production: MALUTI does not yet stop a run from consuming raw material that has not passed its own tests. Only the finished batch is held back at release.
- Available Quarantine status on every received batch
- Available Quarantine lifted only by the qualified person's release
- Not yet Quarantined material stopped from being used in production
Your team
The store keeps received material apart until it is released.
In MALUTI
Every accepted batch starts in quarantine; only a release by the qualified person lifts it.
Checked by MALUTI
- Release is refused for anything that is not in quarantine.
Boundaries
- There is no state "used at risk, pending a result", which Annex 2 allows.
- Entered by hand: where the material physically stands.
Technical detail
- The batch is created with status quarantine by AcceptDelivery. Transform refuses a released input and accepts a quarantined one; no check of the input's own test result.
Store on pallets, off walls, apart from other crops
Done by the site, recorded in MALUTIYour team
The store keeps material on pallets, off the walls and apart from other crops.
In MALUTI
A schedule for the check, who did it and when, the file kept with a fingerprint, so any later change to the file shows, and when it is next due.
Checked by MALUTI
- A check marked as done carries who did it and when.
Boundaries
- MALUTI does not see the store; it keeps the record of your own check.
- Entered by hand: the storage itself and the check are done by people.
Technical detail
- Upkeep schedule and marks (/upkeep.html); no ledger operation of its own.
Control pests in storage, by authorised people only
Done by the site, recorded in MALUTIYour team
Authorised people or a contractor carry out pest control.
In MALUTI
A schedule for pest control, who did it and when, the contractor's report kept with a fingerprint, so any later change to the file shows, and when it is next due.
Checked by MALUTI
- A visit marked as done carries who did it and when.
Boundaries
- MALUTI does not carry out or inspect pest control; it keeps the schedule and the record.
- Entered by hand: the pest control itself.
Technical detail
- Upkeep schedule and marks (/upkeep.html); no ledger operation of its own.
Regulatory context
Stored apart, quarantine separate from approved. Herbal substances stored in their own areas, with different enclosed areas for incoming and for approved material, and protection against insects and rodents.
5Storage conditions and monitoringAvailable with limitsOpenCloseA reading outside its limit is shown on the screen, but it is not yet recorded as an alarm by itself.
Hold and monitor storage conditions
Available with limitsA reading outside its limit is shown on the screen, but it is not yet recorded as an alarm by itself: someone has to see it and act.
- Available Storage condition declared for each batch
- Available Readings from connected instruments
- Shown on the screen only Reading compared with its limit
- Not yet An excursion recorded as an alarm on its own
Your team
Your site keeps the store within its declared conditions and runs the instruments that watch them.
In MALUTI
For each batch, the storage condition from its label, the coldest and warmest it may be kept at, and the basis for it; for each room, its declared conditions and the readings of connected instruments.
Checked by MALUTI
- Only the qualified person can declare a batch's storage condition.
- A condition without its basis (stability data, monograph or licence) is refused.
Boundaries
- MALUTI reads instruments; it does not control heating, cooling or humidity.
- Entered by hand: readings typed in where no instrument is connected.
Technical detail
- Ledger operation SetBatchStorageCondition. The limit judgement runs in the browser (conditions screen), not on the server, so an excursion does not write an alarm record.
Regulatory context
Humidity, temperature and light are held and watched. Where storage needs special conditions of humidity, temperature or light protection, those conditions are both provided and monitored.
Preparing the plant
6Container inspectionBuilt in MALUTIOpenClose
Examine every container for foreign matter and rot
Built in MALUTIYour team
Staff open each container and look for foreign matter, rot and adulteration.
In MALUTI
The examination of the batch: containers examined, containers rejected, and what was found in each rejected one.
Checked by MALUTI
- A rejected container without what was found in it is refused.
Boundaries
- Entered by hand: what the person saw.
Technical detail
- Ledger operation RecordContainerExamination.
Regulatory context
Each container is opened and looked into. Written instructions and records that each container is examined for adulteration or substitution, for foreign matter such as metal, glass, animal parts, stones or sand, and for rot and signs of decay.
7Sieving and cleaning before storageBuilt in MALUTIOpenClose
Sieve out foreign material before storage
Built in MALUTIYour team
Staff sieve and pick out foreign material before the plant goes into storage.
In MALUTI
How the material was cleaned or sieved and how much was removed; zero recorded on purpose counts.
Checked by MALUTI
- A cleaning without its method is refused.
Boundaries
- Entered by hand: the sieving and weighing what was removed.
Technical detail
- Ledger operation RecordCleaningOfMaterial.
Regulatory context
Sieving and selection before the material is stored. Security sieving or another method of removing foreign material, and the cleaning or selection of plant material before the approved herbal substance goes to store.
8Drying and size reduction recordsBuilt in MALUTIOpenClose
Dry to temperature and time, and record both
Built in MALUTIYour team
Staff dry and reduce the plant material.
In MALUTI
Each drying run against its approved process: the temperature and time it asks for, the mass in and out, and who ran it.
Checked by MALUTI
- A run without every parameter the process asks for is refused.
- A value the process expects from an instrument cannot be typed in without a stated reason.
- A run outside the process limits needs an explanation; its output goes to quarantine and a deviation is opened.
Boundaries
- MALUTI does not control the dryer; it records the run and checks it against the process.
- Entered by hand: values typed in where no instrument is connected.
Technical detail
- Ledger operation Transform against a process defined with DefineProcess.
Define a process as data, with its limits
Built in MALUTIYour team
Your qualified person approves each process as a written instruction.
In MALUTI
The process with its version: what it uses and produces, how its mass must balance, parameter limits and where each value comes from, the solvent and its residual limit.
Checked by MALUTI
- Only the qualified person can approve a process.
- A version number already used for that step is refused.
- A process with a solvent is refused without a residual limit.
Boundaries
- Entered by hand: the content of the instruction is your site's.
Technical detail
- Ledger operation DefineProcess.
Regulatory context
Drying and size reduction are instructions, not habits. Processing instructions covering cleaning, drying, crushing and sifting, with the drying time and temperature and the method used to control cut or particle size.
9Dust control and equipment cleaningBuilt in MALUTIOpenClose
Maintain buildings, floors, lighting, changing rooms
Done by the site, recorded in MALUTIYour team
Your site maintains its buildings, floors, lighting and changing rooms.
In MALUTI
A schedule for the maintenance checks, who did them and when, the file kept with a fingerprint, so any later change to the file shows, and when they are next due.
Checked by MALUTI
- A check marked as done carries who did it and when.
Boundaries
- MALUTI does not inspect premises; it keeps the record of your checks.
- Entered by hand: the maintenance itself.
Technical detail
- Upkeep schedule and marks (/upkeep.html); no ledger operation of its own.
Keep the use and cleaning log of each machine
Built in MALUTIYour team
Staff clean each machine to its written procedure and note each use and cleaning.
In MALUTI
The log of each machine: every use and every cleaning, how it was cleaned, when and by whom, in the order they happened.
Checked by MALUTI
- A cleaning without how it was done is refused.
Boundaries
- Entered by hand: the cleaning itself.
Technical detail
- Ledger operations RecordCleaning and GetEquipmentLog.
Clean equipment between tasks and account for the residue
Done by the site, recorded in MALUTIYour team
Staff clean the equipment between tasks and weigh the residue they recover.
In MALUTI
The cleaning of the equipment, and separately how much residue was recovered and where it went.
Checked by MALUTI
- A recovery without the amount and where it went is refused.
Boundaries
- Entered by hand: the cleaning and the weighing.
Technical detail
- Ledger operations RecordCleaning and RecordCleaningRecovery.
Regulatory context
Dust is a cross-contamination problem, and is treated as one. Specific provisions during sampling, weighing, mixing and processing wherever dust is generated, so that cleaning is possible and cross-contamination is avoided.
Extraction
10Extraction run recordsAvailable with limitsOpenCloseEntering the residual solvent result is not available on the screens yet.
Define a process as data, with its limits
Built in MALUTIYour team
Your qualified person approves each process as a written instruction.
In MALUTI
The process with its version: what it uses and produces, how its mass must balance, parameter limits and where each value comes from, the solvent and its residual limit.
Checked by MALUTI
- Only the qualified person can approve a process.
- A version number already used for that step is refused.
- A process with a solvent is refused without a residual limit.
Boundaries
- Entered by hand: the content of the instruction is your site's.
Technical detail
- Ledger operation DefineProcess.
Extract with a solvent and measure the residue
Not on the screens yetEntering the residual solvent result is not available on the screens yet. So a batch extracted with an organic solvent, such as ethanol, cannot be released from the screens.
Your team
The laboratory measures the residual solvent in the extract.
In MALUTI
The residual solvent result against the limit in the process, with the certificate of analysis kept with a fingerprint, so any later change to the file shows.
Checked by MALUTI
- A batch extracted with an organic solvent cannot be released without a residual solvent result.
- A result above the process limit stops the release.
Boundaries
- Extraction with carbon dioxide or by mechanical separation does not need this result, and is not affected.
- Entered by hand: the analysis is the laboratory's.
Technical detail
- Ledger operation RecordResidualSolvent exists behind POST /api/batch/:id/residual; no page calls it. The release gate skips it for solvent classes none and outside_q3c.
Start and run a process
Built in MALUTIYour team
Operators start the extraction on qualified equipment and record the run.
In MALUTI
The run on its equipment: materials in and out with their masses, the process values, and where instrument readings came from.
Checked by MALUTI
- A run cannot start on equipment that is suspended, of the wrong kind, already in use, or whose qualification has run out.
- Material already used or already released cannot go into a run.
- Instrument readings must name the instrument they came from.
Boundaries
- MALUTI records and checks the run; it does not start or stop the machine.
- Entered by hand: values typed in where no instrument is connected, with a stated reason.
Technical detail
- Ledger operations StartRun and Transform; instrument readings carry the sealed chain that covers them.
Regulatory context
Solvent, time, temperature, concentration. For a herbal preparation the instructions give the solvent, the time and the temperature of extraction, and the detail of any concentration stage and the methods used.
11Equipment compatibility with the solventAvailable with limitsOpenCloseRecording the individual qualification stages (URS, IQ, OQ, PQ) is not available on the screens yet.
Register equipment and its qualification
Built in MALUTIYour team
Your qualified person registers each piece of equipment and the date its qualification runs out.
In MALUTI
The equipment: label, kind, location, serial number, service state and the date until which it is qualified.
Checked by MALUTI
- Only the qualified person can register equipment.
- Equipment without the date its qualification runs out is refused.
- A run cannot start on equipment whose qualification has expired.
Technical detail
- Ledger operations RegisterEquipment, SetEquipmentSerial, SetEquipmentService.
Qualify equipment through URS, IQ, OQ, PQ
Not on the screens yetRecording the individual qualification stages (URS, IQ, OQ, PQ) is not available on the screens yet.
Your team
Engineers qualify equipment through URS, IQ, OQ and PQ.
In MALUTI
Each qualification stage against the equipment, in order, with its protocol kept with a fingerprint, so any later change to the file shows.
Checked by MALUTI
- Only an engineer or the qualified person can record a stage.
- A stage cannot be recorded before the stages that come before it, or twice.
Boundaries
- The equipment screen does take the date until which the equipment is qualified, and runs are stopped after it.
- Entered by hand: the qualification work and the protocols.
Technical detail
- Ledger operation RecordQualificationStage exists behind POST /api/module4/equipment/:id/qualification; no page calls it.
Regulatory context
The equipment survives the solvent, and so does the product. Equipment and filtering materials compatible with the extraction solvent, so that nothing is released into the product and nothing is absorbed out of it.
12Yield and active substance balanceAvailable with limitsOpenCloseClosing the active substance balance is not available on the screens yet.
Investigate a significant deviation from expected yield
Built in MALUTIYour team
Your site investigates a yield that comes out wrong.
In MALUTI
Each run compared with the ratio its process declares; a yield outside the tolerance opens a deviation on the run.
Checked by MALUTI
- A yield outside the declared tolerance opens a deviation and sends the output to quarantine.
- Such a run needs a stated explanation.
- A batch with an open deviation cannot be released.
Boundaries
- Entered by hand: the investigation and its conclusion.
Technical detail
- Ledger operation Transform (ratio breach → deviation record).
Close the balance on the active substance
Not on the screens yetClosing the active substance balance is not available on the screens yet.
Your team
The laboratory assays every part that went in and came out.
In MALUTI
The balance of the active substance across a run, from the laboratory results of every part.
Checked by MALUTI
- The balance cannot be closed while any part lacks its laboratory result.
- A gap above the process tolerance needs a stated explanation.
Boundaries
- Entered by hand: the assays are the laboratory's.
Technical detail
- Ledger operation ReconcileActive exists behind POST /api/transform/:id/reconcile-active; no page calls it.
Regulatory context
A yield that comes out wrong is investigated. Any significant deviation from the expected yield is investigated and recorded.
Testing and release
13SamplingBuilt in MALUTIOpenClose
Take a sample to a sampling plan
Built in MALUTIYour team
A person who knows the plant takes the sample.
In MALUTI
The sample: what it was taken of, quantity and unit, where it is stored, and the sampling plan it was taken to.
Checked by MALUTI
- Only the qualified person can record a sample.
- A sample without where it is stored, or without a sampling plan in force, is refused.
Boundaries
- Entered by hand: the sampling itself.
Technical detail
- Ledger operation TakeSample.
Regulatory context
Sampling by someone who knows the plant. Sampling carried out with special care by personnel with particular expertise, because plant material is heterogeneous, and each batch identified by its own documentation.
14Reference samplesBuilt in MALUTIOpenClose
Keep reference and retention samples
Built in MALUTIYour team
Your site keeps a reference sample of the plant and disposes of it at the end of its period.
In MALUTI
The reference sample with its quantity, place and retention period, and its disposal.
Checked by MALUTI
- A reference sample must be enough for two full analyses.
- Retention cannot be counted where the batch has no shelf life to count it from.
Boundaries
- Entered by hand: keeping the sample physically.
Technical detail
- Ledger operations TakeSample and DisposeSample.
Regulatory context
A reference sample of the plant is kept. A reference sample of the plant material, and samples of unmilled material where powders are used.
15Qualified quality control staffBuilt in MALUTIOpenClose
Record what a person is qualified by
Built in MALUTIYour team
Your site makes sure the people in quality control can recognise the plant and its adulteration.
In MALUTI
What each person is qualified by: what, from whom, when, and the document kept with a fingerprint, so any later change to the file shows.
Checked by MALUTI
- Only the qualified person can record a qualification.
- A diploma or certificate without its document is refused.
Boundaries
- MALUTI records what a person is qualified by; it does not test whether they can recognise adulteration.
- Entered by hand: experience is recorded in words.
Technical detail
- Ledger operation RecordQualification, against the person's certificate.
Regulatory context
Quality control can recognise adulteration by eye. Quality control personnel with particular expertise and experience in herbal substances, able to recognise adulteration, fungal growth, infestation and non-uniformity within a delivery.
16Identity and quality testingAvailable with limitsOpenCloseRecording the identity test of a received batch is not available on the screens yet.
Run an identity test on every batch received
Not on the screens yetRecording the identity test of a received batch is not available on the screens yet.
Your team
The laboratory tests the identity of every batch received, or your site relies on the supplier's certificate where the supplier has earned it.
In MALUTI
The identity test of the batch: your own test or the supplier's certificate, and the verdict.
Checked by MALUTI
- A supplier certificate is accepted instead of a test only when that supplier has enough full analyses on record.
Boundaries
- An identity test is not required before the material is used, or before the finished batch is released.
- Entered by hand: the test itself is the laboratory's.
Technical detail
- Ledger operation RecordIdentityTest exists behind POST /api/module1/batch/:id/identity; no page calls it.
Regulatory context
Identity and quality against the monograph. Identity and quality determined in accordance with the current European guidance on herbal medicinal products and the relevant Ph. Eur. monographs.
17Batch releaseAvailable with limitsOpenCloseA batch extracted with an organic solvent cannot be released from the screens yet, because its residual solvent result cannot be entered there.
Release a batch
Available with limitsA batch extracted with an organic solvent cannot be released from the screens yet, because its residual solvent result cannot be entered there. Batches from drying, carbon dioxide extraction or mechanical separation are not affected.
- Available Release signed by the qualified person
- Available Release refused until specification, certificate, deviations and cold chain are in order
- Not yet Release of a batch extracted with an organic solvent
Your team
Your qualified person decides and signs the release.
In MALUTI
The release: who signed, their role, the declaration and the time — and every reason it was refused until the batch was in order.
Checked by MALUTI
- Only the qualified person can release.
- Release is refused if the batch is past its expiry, was never held to a specification, lacks a passing certificate of analysis, has an open deviation, a cold chain excursion, a run cut short, or a missing or failed residual solvent result.
- Release is refused while a number typed in by one person still waits for its second check.
Boundaries
- Entered by hand: the decision is the qualified person's.
Technical detail
- Ledger operation SignRelease; the release gates run in the ledger. The time on the record is the transaction time, which the sending client sets.
Assemble a batch dossier
Built in MALUTIYour team
Your qualified person assembles the batch dossier for review or for an inspector.
In MALUTI
One document for the batch, assembled from what is recorded, each figure with the record it came from. The document is kept at the site with its fingerprint recorded.
Checked by MALUTI
- The dossier calculates nothing of its own: where there is no record, it says so.
Boundaries
- The dossier does not yet mark figures that were corrected after they were first entered (Annex 11 §8.2).
Technical detail
- Assembled by services/dossier.js; its hash is written to the ledger.
Regulatory context
The authorised person releases the batch. Certification by the authorised person before release, against the batch dossier.
What a launch needs
- Instruments. Readings come from instruments that can report them; each one is surveyed at your site before we promise to connect it. MALUTI reads instruments; it does not control the dryer, the extractor or the store climate.
- Your laboratory. Certificates of analysis are kept as files and results are entered against the specification. MALUTI does not run analyses.
- Your procedures. Processes, specifications and sampling plans are approved by your qualified person; MALUTI holds them and checks the work against them.
Modules this path uses
- Raw materials
- Telemetry and electronic batch records
- Deviations and corrective actions
- Suppliers, contracts and risk
- Personnel, fitness for work and room access
Taken from the screens each step is done on. The subscription covers the software; implementation, hardware and integrations are quoted separately. Prices →
Full catalogue and how it is countedShowHide
EU GMP Part I · EU GMP Annex 7 · EU GMP Part II, and the path above: 61 of 84 record types kept in MALUTI · 21 not built yet · 2 outside the software.
A record type is one thing a clause asks a site to record, counted once even when two documents or a step ask for it. “Kept in MALUTI” covers what MALUTI does itself and the record it keeps of work your site does. It is a count of what we have mapped, not a share of the regulation — and not the same as the check above: 4 record types counted as kept cannot yet be recorded from the screens.
Not built yet (21)
- Keep a visitor policy with classes of person EU GMP ch. 2 §2.13 source
- Use only starting materials that Quality Control has released EU GMP ch. 5 §5.34 source
- Clear the work area and equipment before a processing operation starts EU GMP ch. 5 §5.40 source
- Record who took material out of store for a run EU GMP Part II 6.3 source
- Derive the exposure limits behind a shared line EU GMP ch. 5 §5.20 source
- Hold the periodic management review of the quality system EU GMP ch. 1 §1.6 source
- Take the daily statement that bars a person from the clean room, and act on it EU GMP Part II 3.24 source
- Hold the written description of how a machine is built, and keep it current EU GMP Part II 5.16 source
- Keep the installation record of each utility system for its whole life: drawings, materials, specification EU GMP Part II 4.20 source
- For a bulk delivery in a non-dedicated tanker, hold the assurance that it arrived clean EU GMP Part II 7.22 source
- Record why a material was accepted on its certificate alone, without a test of our own EU GMP Part II 7.32 source
- Use the oldest stock first EU GMP Part II 7.42 source
- Re-evaluate material after long storage EU GMP Part II 7.50 source
- Reprocess or rework, after investigating why EU GMP Part II 14.2–14.3 source
- Blend only batches that passed, trace the blend to each of them, and date it by the oldest EU GMP Part II 8.41, 8.44, 8.47 source
- Record what was recovered — solvent, mother liquor — and the testing that let it back into the process EU GMP Part II 14.40–14.43 source
- Record a contamination event in a culture, identify what grew, and let it decide the fate of the material EU GMP Part II 18.36, 18.37 source
- Hold the impurity profile of the substance, and compare it against the registered one at intervals EU GMP Part II 11.21, 11.22 source
- Give the substance a retest date from its stability data, and retest it before that date passes EU GMP Part II 11.61, 11.63 source
- When we repack or resell someone else's substance, keep the chain back to the original manufacturer and name them to the buyer EU GMP Part II 17.20, 17.61 source
- Hold records for the required years EU GMP Part II 6.13 source
Built in MALUTI (55)ShowHide
- Record what a person is qualified by EU GMP ch. 2 §2.1 source
- Keep the record of a consultant: name, address and service EU GMP ch. 2 §2.23 source
- File fitness for work EU GMP ch. 2 §2.16 source
- Record training and its expiry EU GMP ch. 2 §2.10–2.12 source
- Assess periodically whether training actually worked EU GMP ch. 2 §2.11 source
- Keep training programmes approved by the head of Production or of Quality Control EU GMP ch. 2 §2.11 source
- Grant access to rooms EU GMP ch. 3 §3.5 source
- Keep an organisation chart showing who answers to whom EU GMP ch. 2 §2.2 source
- Write down the duties and the authority of a responsible position EU GMP ch. 2 §2.3 source
- Declare what each room must hold, and watch it EU GMP ch. 3 §3.19 source
- Register equipment and its qualification EU GMP ch. 3 §3.34, §3.41 source
- Keep the use and cleaning log of each machine EU GMP Part II 6.20 source
- Examine each container: labels, damage, broken seals EU GMP Part II 7.20 source
- Run an identity test on every batch received EU GMP Part II 7.30 source
- Hold incoming material in quarantine until released EU GMP Annex 7 §1 source
- Hold the approved manufacturing formula, with its versions and its effective date EU GMP ch. 4 §4.17, §4.3 source
- Define a process as data, with its limits EU GMP ch. 4 §4.18 source
- Start and run a process EU GMP ch. 4 §4.20 source
- Investigate a significant deviation from expected yield EU GMP ch. 5 §5.44 source
- Run an on-going stability programme EU GMP ch. 6 §6.27–6.31 source
- Trend results and investigate what falls outside EU GMP ch. 6 §6.9, 6.35 source
- Raise and close deviations EU GMP ch. 5 §5.15 source
- Run CAPA through action and verification EU GMP ch. 1 §1.4(xiv) source
- Raise an incident and find the batches around it EU GMP ch. 8 source
- Record a complaint from outside: who complained, what was answered, and what happened to the batch EU GMP Part II 15.10–15.12 source
- Run self-inspection to a programme EU GMP ch. 9 source
- Approve and supersede procedures EU GMP ch. 4 source
- Register counterparties and score suppliers EU GMP ch. 7 source
- Compile the annual product quality review EU GMP ch. 1 §1.10 source
- Recall released product EU GMP ch. 8 §8.22–8.30 source
- Control packaging materials and their storage EU GMP ch. 5 §5.46 source
- Clear the line before packing, and record it EU GMP Part II 9.44 source
- Issue, reconcile and destroy labels EU GMP Part II 9.30–9.33 source
- Record a batch that came back: from whom, how much, why, and what was done with it EU GMP Part II 14.50–14.52 source
- Assemble a batch dossier EU GMP ch. 4 source
- A grower declares a delivery EU GMP Annex 7 §13 source
- Hold and monitor storage conditions EU GMP Annex 7 §4 source
- Dry to temperature and time, and record both EU GMP Annex 7 §9 source
- Examine every container for foreign matter and rot EU GMP Annex 7 §10 source
- Sieve out foreign material before storage EU GMP Annex 7 §11 source
- Approve a specification, every limit naming its method EU GMP Annex 7 §8 source
- Take a sample to a sampling plan EU GMP Annex 7 §13, Part II 7.33 source
- Keep reference and retention samples EU GMP Part II 11.71 source
- Qualify equipment through URS, IQ, OQ, PQ EU GMP Annex 7 §6 source
- Calibrate instruments against a schedule EU GMP Part II 5.30–5.35 source
- Run preventative maintenance to a schedule, with someone named for each machine EU GMP Part II 5.20 source
- Judge how far a supplier certificate can be trusted EU GMP Part II 7.31 source
- Re-check supplier certificates at the interval this site declares EU GMP Part II 7.31 source
- Hold seed lots and cell banks as master and working generations, and count the passages between them and the product EU GMP Part II 18.22 source
- Run formal change control EU GMP Part II 13, Annex 15 §11 source
- Seal so the receiver is alerted to tampering EU GMP Part II 9.46 source
- Record and investigate an incident of the system itself, and say what it did to the records made at that time EU GMP Part II 5.46 source
- Extract with a solvent and measure the residue ICH Q3C source
- Close the balance on the active substance MALUTI decision our own design decision, not a regulation
- Release a batch EU GMP Annex 16 §1.6 source
Done by the site, recorded in MALUTI (6)ShowHide
- Maintain buildings, floors, lighting, changing rooms EU GMP ch. 3 §3.2, §3.3, §3.31 source
- Control pests in storage, by authorised people only EU GMP Annex 7 §1 source
- Hold written contracts for outsourced work EU GMP ch. 7 §7.14–7.17 source
- Store on pallets, off walls, apart from other crops EU GMP Annex 7 §1, §2 source
- Audit suppliers and keep the reports EU GMP Annex 7 §7 source
- Clean equipment between tasks and account for the residue SAHPRA Annex A §5 additional source, not EU GMP
Outside the software (2)ShowHide
- Examine a person medically and read the finding EU GMP ch. 2 §2.16 source
- Run the analysis itself EU GMP ch. 7 source
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