Herbal medicinal products
Plant material, herbal preparations and extracts.
EU GMP Part I · EU GMP Annex 7 · EU GMP Part II
61 of 84 record types kept in MALUTI
21 not built yet · 2 outside the software
See the path step by step →Industries
Start from what you make.
Each direction is governed by documents of its own, named on its card. Open yours to see what MALUTI keeps for it, what is not built yet and what stays with your site.
Active substances
Chemical and natural active substances.
EU GMP Part II · EU GMP Annex 1
26 of 91 record types kept in MALUTI
65 not built yet
See what the rules ask →Tablets, capsules and other non-sterile forms
Solid forms, liquids, creams and ointments.
EU GMP Part I
47 of 58 record types kept in MALUTI
9 not built yet · 2 outside the software
Not read into our catalogue yet, and not counted: Annex 10 (pressurised metered dose aerosols for inhalation).
See the path step by step →Sterile products
Aseptic preparation and terminal sterilisation.
EU GMP Part I · EU GMP Annex 1
52 of 112 record types kept in MALUTI
58 not built yet · 2 outside the software
See the path step by step →Medicinal gases
Gases and gas mixtures in cylinders and bulk.
EU GMP Part I · EU GMP Annex 6
52 of 60 record types kept in MALUTI
6 not built yet · 2 outside the software
See the path step by step →Radiopharmaceuticals
Radioactive medicinal products.
EU GMP Part I · EU GMP Annex 3
54 of 69 record types kept in MALUTI
13 not built yet · 2 outside the software
See the path step by step →Biological medicinal products
Products made by or from living organisms.
EU GMP Part I · EU GMP Annex 2
58 of 79 record types kept in MALUTI
19 not built yet · 2 outside the software
Not read into our catalogue yet, and not counted: Annex 14 (products derived from human blood or plasma).
See the path step by step →Advanced therapy medicinal products
Gene, cell and tissue therapies.
EU GMP Part IV
24 of 34 record types kept in MALUTI
10 not built yet
See the path step by step →Wholesale distribution
Storage and transport under Good Distribution Practice.
Catalogue in preparation
Its own certificate format and its own guidelines (EU GDP). Their requirements are not read into our catalogue yet, so no figure is shown.
Ask about your process →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.
Every record type with its clause, who at a site answers for what, and the limits of the catalogue: Detailed catalogue →
Your GMP certificate, line by line.
Your authorisation lists operations in the EU format. Tick the ones printed on yours and see the records they ask for.
- 152 operation codes
- 7 production paths written out step by step, plus one shared by all: who is responsible
- 252 record types in the catalogue, 135 built
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