Maluti QMS — home
Menu
Contact

Industries · Tablets, capsules and other non-sterile forms

Tablets, capsules and other non-sterile forms step by step.

Solid forms, liquids, creams and ointments. Below: the path of one batch as the rules describe it, what MALUTI records at each step, and every record type these documents ask for — built or not yet.

The path of a batch

Non-sterile dosage forms · EU GMP Part I · 20 steps

Your certificate, line by line →

Tablets and capsules

No annex of its own: Part I governs it whole, and that is why this is the shortest honest chain we could write. Weighing checked by a second person, the line clear before anything starts, the yield reconciled, the batch record built from the formula in force.

Liquids, creams and ointments

Everything the solid forms need, and four more from Annex 9, because a liquid is made in pipework rather than in a press: the water specified and monitored, the pipework cleanable and connected where it should be, homogeneity held through the filling, and a stated limit on bulk that waits.

Incoming material

  • The supplier of a starting material is approved

    Built in MALUTI

    Selection, qualification, approval and maintenance of suppliers documented, with the supporting evidence for each approval kept.

    ch. 5 §5.27, §5.29

  • Each delivery is checked and labelled

    Built in MALUTI

    Every delivery checked for package integrity, tamper-evident seal and agreement between the delivery note, the order and the supplier labels; the receiving checks documented and the containers labelled.

    ch. 5 §5.30, §5.32

  • Nothing is used before Quality Control releases it

    2 of 3 built

    Incoming materials quarantined on receipt; only materials released by Quality Control and within their retest period are used.

    ch. 5 §5.5, §5.34

  • Identity is tested on every batch

    Built in MALUTI

    Identification testing of each batch of starting material, as a minimum, according to Annex 8.

    ch. 5 §5.35

Making the batch

  • The manufacturing formula is approved and current

    Built in MALUTI

    A manufacturing formula naming the product and its specification, the form, strength and batch size, and every starting material with the amount of each.

    ch. 4 §4.17

  • Weighing is done by named people and checked by a second

    Not built yet

    Materials dispensed only by designated persons following a written procedure; each weight or volume independently checked and the check recorded; what is dispensed for a batch kept together and labelled.

    ch. 5 §5.37, §5.38, §5.39

  • The line is clear before anything starts

    1 of 2 built

    Before processing begins, the area and equipment are clean and free of materials, products, residues and documents not required for this operation.

    ch. 5 §5.40

  • Everything in the room says what it is

    Not built yet

    Materials, bulk containers, major equipment and where appropriate rooms labelled with the product, its strength and the batch number, and the stage of production.

    Not built: nothing here labels a room or a bulk container with the product, its strength and the stage. The batch is labelled; the room it stands in is not.

    ch. 5 §5.12

  • In-process controls are carried out and recorded

    Built in MALUTI

    Any necessary in-process and environmental controls carried out and recorded, by methods approved by Quality Control.

    ch. 5 §5.43, ch. 6 §6.18

  • The water is specified and monitored

    Not built yet

    The chemical and microbiological quality of water used in production specified and monitored, and a validated flushing procedure after chemical sanitisation.

    Not built: water for production is not specified or monitored anywhere. The site files its water documents, and irrigation water has its own gap — neither is this.

    Annex 9 §4

  • The pipework can be cleaned, and it goes where it should

    1 of 2 built

    Tanks, pipework and pumps designed so they can be cleaned, with a minimum of dead-legs; and a check that material transferred by pipeline arrives at the correct destination.

    Annex 9 §2, §6

  • The mixture stays homogeneous while it is filled

    Built in MALUTI

    Mixing and filling validated, and homogeneity maintained at the start of filling, after stoppages and at the end.

    Annex 9 §8

  • Bulk that waits has a stated limit

    Not built yet

    Where the finished product is not packaged immediately, the maximum period of storage and the storage conditions specified and adhered to.

    Not built: nothing holds a maximum storage period for bulk that waits for packaging.

    Annex 9 §9

  • The yield is reconciled, and a deviation is investigated

    Built in MALUTI

    Checks on yields and reconciliation of quantities; any significant deviation from the expected yield recorded and investigated.

    ch. 5 §5.8, §5.44

Packaging, record and release

  • Line clearance before packaging, by a check-list

    Built in MALUTI

    Before packaging begins, the area, lines and printing machines are clear of anything previously used, checked against a check-list; the product name and batch number displayed at each station.

    ch. 5 §5.50, §5.51

  • Printed materials are controlled, and printing is checked

    Built in MALUTI

    Printed packaging materials stored securely and issued only by authorised people under a documented procedure; the correct performance of any printing checked and recorded.

    ch. 5 §5.46, §5.55

  • Packaging reconciles, and what is left over is destroyed

    Built in MALUTI

    Any significant discrepancy between bulk product, printed materials and units produced investigated and accounted for before release; unused batch-coded materials destroyed and the destruction recorded.

    ch. 5 §5.61, §5.62

  • The batch record is the batch, written down

    Built in MALUTI

    A batch processing record and a batch packaging record for each batch, based on the approved formula, instructions and packaging instructions in force.

    ch. 4 §4.20, §4.21

  • Finished product waits in quarantine until it is certified

    Built in MALUTI

    Finished products held in quarantine until released; certification by the authorised person against the batch dossier before release.

    ch. 5 §5.63, Annex 16 §1.6

  • A sample of the batch is kept

    Built in MALUTI

    A reference sample of the finished product kept for at least one year after the expiry date, and a retention sample in its own pack.

    Annex 19 §3.1, §3.2

What the rules ask, and what is built.

EU GMP Part I, and the path of a batch above. 47 of 58 record types kept in MALUTI · 9 not built yet · 2 outside the software.

A record type in our catalogue is one thing a clause asks a site to record. Each is counted once, even when two documents or a step of the path ask for it. “Kept in MALUTI” covers what MALUTI does itself and the record it keeps of work your site does. The count shows what we have mapped, not a share of the regulation.

Not read into our catalogue yet, and not counted: Annex 10 (pressurised metered dose aerosols for inhalation). The operations they govern are counted here by Part I alone.

Not built yet (9)

  • Keep a visitor policy with classes of person EU GMP ch. 2 §2.13
  • Use only starting materials that Quality Control has released EU GMP ch. 5 §5.34
  • Clear the work area and equipment before a processing operation starts EU GMP ch. 5 §5.40
  • Record who took material out of store for a run EU GMP ch. 5 §5.37
  • Derive the exposure limits behind a shared line EU GMP ch. 5 §5.20
  • Hold the periodic management review of the quality system EU GMP ch. 1 §1.6
  • Sample the water system on a plan, and investigate its excursions EU GMP Annex 1 §6.13, §6.14 · path step Annex 9 §4
  • Check that material moved by pipeline arrives where it should EU GMP Annex 9 §6 · path step Annex 9 §2, §6
  • Hold bulk that waits for packaging inside a stated maximum period EU GMP Annex 9 §9 · path step Annex 9 §9

And one step of the path with nothing yet to record it — not counted above, because there is no record type for it in the catalogue yet:

  • Everything in the room says what it is ch. 5 §5.12
Built in MALUTI (43)ShowHide
  • Record what a person is qualified by EU GMP ch. 2 §2.1
  • Keep the record of a consultant: name, address and service EU GMP ch. 2 §2.23
  • File fitness for work EU GMP ch. 2 §2.16
  • Record training and its expiry EU GMP ch. 2 §2.10–2.12
  • Assess periodically whether training actually worked EU GMP ch. 2 §2.11
  • Keep training programmes approved by the head of Production or of Quality Control EU GMP ch. 2 §2.11
  • Grant access to rooms EU GMP ch. 3 §3.5
  • Keep an organisation chart showing who answers to whom EU GMP ch. 2 §2.2
  • Write down the duties and the authority of a responsible position EU GMP ch. 2 §2.3
  • Declare what each room must hold, and watch it EU GMP ch. 3 §3.19
  • Register equipment and its qualification EU GMP ch. 3 §3.34, §3.41
  • Keep the use and cleaning log of each machine EU GMP ch. 4 §4.31
  • Examine each container: labels, damage, broken seals EU GMP ch. 5 §5.30
  • Run an identity test on every batch received EU GMP ch. 5 §5.35
  • Hold incoming material in quarantine until released EU GMP ch. 5 §5.5
  • Hold the approved manufacturing formula, with its versions and its effective date EU GMP ch. 4 §4.17, §4.3
  • Define a process as data, with its limits EU GMP ch. 4 §4.18
  • Start and run a process EU GMP ch. 4 §4.20
  • Investigate a significant deviation from expected yield EU GMP ch. 5 §5.44
  • Run an on-going stability programme EU GMP ch. 6 §6.27–6.31
  • Trend results and investigate what falls outside EU GMP ch. 6 §6.9, 6.35
  • Raise and close deviations EU GMP ch. 5 §5.15
  • Run CAPA through action and verification EU GMP ch. 1 §1.4(xiv)
  • Raise an incident and find the batches around it EU GMP ch. 8
  • Record a complaint from outside: who complained, what was answered, and what happened to the batch EU GMP ch. 8 §8.5–8.14
  • Run self-inspection to a programme EU GMP ch. 9
  • Approve and supersede procedures EU GMP ch. 4
  • Register counterparties and score suppliers EU GMP ch. 7
  • Compile the annual product quality review EU GMP ch. 1 §1.10
  • Recall released product EU GMP ch. 8 §8.22–8.30
  • Control packaging materials and their storage EU GMP ch. 5 §5.46
  • Clear the line before packing, and record it EU GMP ch. 5 §5.50
  • Issue, reconcile and destroy labels EU GMP ch. 5 §5.46, §5.61, §5.62
  • Record a batch that came back: from whom, how much, why, and what was done with it EU GMP ch. 5 §5.70
  • Assemble a batch dossier EU GMP ch. 4
  • A grower declares a delivery Lesotho LN40 reg. 18(2) · path step ch. 5 §5.30, §5.32
  • Release a batch EU GMP Annex 16 §1.6 · path step ch. 5 §5.5, §5.34
  • Approve a specification, every limit naming its method EU GMP Annex 7 §8 · path step ch. 5 §5.35
  • Take a sample to a sampling plan EU GMP Annex 7 §13, Part II 7.33 · path step ch. 5 §5.35
  • Keep the risk matrix and the validation file ICH Q9 · path step Annex 9 §8
  • Close the balance on the active substance MALUTI decision · path step ch. 5 §5.8, §5.44
  • Pack after removing sub-standard material SAHPRA §8.4 · path step ch. 5 §5.61, §5.62
  • Keep reference and retention samples EU GMP Annex 19 §3–4 · path step Annex 19 §3.1, §3.2
Done by the site, recorded in MALUTI (4)ShowHide
  • Maintain buildings, floors, lighting, changing rooms EU GMP ch. 3 §3.2, §3.3, §3.31
  • Control pests in storage, by authorised people only EU GMP ch. 3 §3.4
  • Hold written contracts for outsourced work EU GMP ch. 7 §7.14–7.17
  • Audit suppliers and keep the reports EU GMP Annex 7 §7 · path step ch. 5 §5.27, §5.29
Outside the software (2)ShowHide
  • Examine a person medically and read the finding EU GMP ch. 2 §2.16
    The examination is a doctor's work and the finding is medical. We hold the outcome in three words, the dates and who recorded them. A field for a diagnosis does not exist anywhere in this system, because a record that only ever grows cannot take a disclosure back.
  • Run the analysis itself EU GMP ch. 7
    The laboratory has its own accreditation, its own methods and its own instruments. We hold the certificate and its hash, the limits it was judged against, the verdict, and the state of that laboratory's licence on the day it signed.

Let’s map MALUTI to your site.

Tell us about one of your processes. We show the matching functions, name the integrations it needs and prepare an individual offer. Documents for supplier evaluation →

Discuss your configuration