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Industries · Radiopharmaceuticals

Radiopharmaceuticals step by step.

Radioactive medicinal products. 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

Radiopharmaceuticals · EU GMP Annex 3 · 19 steps

Your certificate, line by line →

A short-lived radionuclide

It decays faster than the laboratory works, so it leaves before the tests are finished. The annex does not forbid that; it names the stages instead — a designated person lets it travel under quarantine, the authorised person certifies conditionally, and finally only when every result is in. The ledger holds all three — the assessment, the conditional certification with the tests still open named on it, and the final one — and a result that arrives after dispatch gets an answer of its own.

A long-lived radionuclide

Time enough to test first, so the ordinary order holds: everything meets its acceptance criteria before certification. The annex even allows the sample to be held until the activity has fallen far enough to measure the rest.

Before production

  • The site says which rules govern which step

    Built in MALUTI

    The manufacturer describes and justifies the steps for the active substance and the finished product, and which part of the guide — I or II — applies to each of them.

    Annex 3 §4

  • Processes and systems are validated, and their ranges written down

    Built in MALUTI

    Qualification and validation applied with a risk approach; new processes validated prospectively, computerised systems under Annex 11; critical parameters identified and the ranges for reproducible operation defined.

    Annex 3 §12, §35, §36

  • Starting materials come from approved suppliers

    Built in MALUTI

    A system to verify the quality of starting materials, with supplier approval that gives assurance the material consistently meets its specification.

    Annex 3 §47

People and the room

  • Everyone in the area has training for this work in particular

    Built in MALUTI

    Production, analytical control and release carried out by people with additional competence in radiation protection, and everyone working where radioactive products are made — cleaning and maintenance included — additionally trained for it.

    Annex 3 §13, §14

  • The way in is through the gowning area, and it is restricted

    2 of 3 built

    Access to the manufacturing areas via a gowning area and restricted to authorised personnel.

    Annex 3 §18

  • One working area holds one product at a time

    1 of 2 built

    Production of different radioactive products in the same working area — a hot-cell or a laminar unit — at the same time avoided, against cross-contamination and mix-up.

    Annex 3 §34

Making it

  • Every material and the product itself have a written specification

    Built in MALUTI

    Specifications for raw materials, labelling and packaging materials, critical intermediates and the finished product; acceptance criteria including the chemical identity of the isotope, radioactive concentration, purity and specific activity.

    Annex 3 §30, §31

  • The equipment log carries the product, the batch and the signature

    Built in MALUTI

    Records of major equipment use, cleaning, sanitisation or sterilisation and maintenance showing the product name and batch number, the date and time, and the signature of the people involved.

    Annex 3 §32

  • The membrane filter is integrity tested

    Not built yet

    Integrity testing of the membrane filter for aseptically filled products, done in a way that respects radiation protection and keeps the filter sterile.

    Annex 3 §37

  • Labelling happens before filling, and the vial stays visible

    2 of 3 built

    Most labelling of the direct container done before manufacturing; empty sterile vials may be partly labelled beforehand provided sterility is not compromised and the filled vial can still be inspected.

    Annex 3 §38

  • Monitoring data is evaluated as part of the release, not filed away

    Not built yet

    Data generated by the monitoring of premises and processes rigorously recorded and evaluated as part of the release process.

    Annex 3 §11

Releasing it

  • It leaves before the tests are finished, in named stages

    Built in MALUTI

    A designated person assesses the batch records and the testing done so far and lets the batch travel to the clinical department under quarantine; the authorised person certifies conditionally before use and finally once every result is in.

    Annex 3 §39

  • A long-lived product is tested in full before it is certified

    Built in MALUTI

    Radionuclides with long half-lives tested to meet every acceptance criterion before release and certification; samples may be held first to let the activity decay, and all tests including sterility run as soon as possible.

    Annex 3 §41, §42

  • What is weighed before dispatch is written down beforehand

    Built in MALUTI

    A written procedure detailing the assessment of production and analytical data to be considered before the batch is dispatched.

    Annex 3 §43

  • A failing result after dispatch has a path of its own

    Built in MALUTI

    A procedure describing what the authorised person does when out-of-specification results arrive after dispatch and before expiry; the event investigated, the corrective and preventive actions taken, and the whole of it documented.

    Annex 3 §45

  • The clinic is told, and the traceability system makes that possible

    Built in MALUTI

    Information given to the clinical responsible persons where necessary, supported by a traceability system for radiopharmaceuticals.

    Annex 3 §46

  • It may travel before the results, but it may not be given

    Built in MALUTI

    Distribution under controlled conditions before all the test results are available is acceptable, provided the receiving institute does not administer the product until satisfactory results have arrived and been assessed by a designated person.

    Annex 3 §51

After it is gone

  • Samples outlive the product

    Built in MALUTI

    Samples of each batch of bulk formulated product kept at least six months after the expiry of the finished product, and samples of starting materials at least two years after its release.

    Annex 3 §48, §49

  • Records are held for at least three years

    1 of 2 built

    Records retained for at least three years unless national requirements name another period.

    Annex 3 §33

What the rules ask, and what is built.

EU GMP Part I · EU GMP Annex 3, and the path of a batch above. 54 of 69 record types kept in MALUTI · 13 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 built yet (13)

  • 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
  • Run the environmental monitoring programme, with an alert level below the action limit EU GMP Annex 3 §11
  • Test the sterilising filter before use and after use, and keep both results with the batch EU GMP Annex 3 §37
  • Keep two radioactive products out of one working area at the same time EU GMP Annex 3 §34
  • Label the container before filling, and keep the filled vial visible EU GMP Annex 3 §38
  • Hold records for the required years EU GMP Annex 3 §33
  • Qualify a person for aseptic gowning, and reassess at least annually EU GMP Annex 1 §7.4 · path step Annex 3 §18
  • Investigate an exceeded action limit and name the batches it touched EU GMP Annex 1 §9.13 · path step Annex 3 §11
Built in MALUTI (49)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 Annex 3 §14
  • 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 Annex 3 §32
  • 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 Annex 3 §36
  • 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
  • Approve a specification, every limit naming its method EU GMP Annex 3 §30, §31
  • Keep reference and retention samples EU GMP Annex 3 §48, §49
  • Keep the risk matrix and the validation file EU GMP Annex 3 §12, §26
  • Qualify equipment through URS, IQ, OQ, PQ EU GMP Annex 3 §12
  • Release a batch EU GMP Annex 3 §41
  • Release in stages: transport under quarantine, then conditional certification, then final EU GMP Annex 3 §39
  • Act on a failing result that arrives after dispatch and before expiry EU GMP Annex 3 §45
  • Tell the clinical responsible person, and be able to show whom and when EU GMP Annex 3 §46
  • Monitor conditions in transit EU GMP Annex 3 §51
  • Record who goes in and out Lesotho LN40 reg. 14(2)(a)(iii) · path step Annex 3 §18
  • Print a label carrying the seven required fields Lesotho LN40 reg. 21(2) · path step Annex 3 §38
  • Take a sample to a sampling plan EU GMP Annex 7 §13, Part II 7.33 · path step Annex 3 §41, §42
  • Transfer custody by name, vehicle and receiver Lesotho LN40 reg. 23(2)(f) · path step Annex 3 §46
  • Store records so they survive disaster, crime and neglect SAHPRA Annex B §1 · path step Annex 3 §33
Done by the site, recorded in MALUTI (5)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 Annex 3 §47
  • Clean equipment between tasks and account for the residue SAHPRA Annex A §5 · path step Annex 3 §34
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.

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