Industries · Operations

From your product to its records.

Answer what you make, tick the operations printed on your certificate, and the records follow — each one with the clause behind it and whether MALUTI keeps it today. Ticking changes nothing: it is a look, one answer at a time.

What is what you make used as? One answer at a time: opening a tab closes the others.

Medicines for people Veterinary medicines Active substances Medical devices Investigational products Something else

Every part of the certificate is listed below.

The same substance falls under a different set of rules depending on what it is for. Answering this before the operations is what makes the operations mean anything.

0 operations selected

1 · Manufacturing operations - medicinal products

1.1 Sterile products12 operations · 11 written out as a processOpenClose

1.1.1 Aseptically prepared (processing operations for the following dosage forms)

1.1.1.1 Large volume liquids Part I · Annex 1 52 of 112 records kept Process →
1.1.1.2 Lyophilisates Part I · Annex 1 52 of 112 records kept Process →
1.1.1.3 Semi-solids Part I · Annex 1 52 of 112 records kept Process →
1.1.1.4 Small volume liquids Part I · Annex 1 52 of 112 records kept Process →
1.1.1.5 Solids and implants Part I · Annex 1 52 of 112 records kept Process →
1.1.1.6 Otherfree text Part I · Annex 1 52 of 112 records kept Process →

1.1.2 Terminally sterilised (processing operations for the following dosage forms)

1.1.2.1 Large volume liquids Part I · Annex 1 52 of 112 records kept Process →
1.1.2.2 Semi-solids Part I · Annex 1 52 of 112 records kept Process →
1.1.2.3 Small volume liquids Part I · Annex 1 52 of 112 records kept Process →
1.1.2.4 Solids and implants Part I · Annex 1 52 of 112 records kept Process →
1.1.2.5 Otherfree text Part I · Annex 1 52 of 112 records kept Process →

1.1.3 Batch certification Part I · Annex 1 · Annex 16 48 of 108 records kept

1.2 Non-sterile products18 operations · 8 written out as a processOpenClose

1.2.1 Non-sterile products (processing operations for the following dosage forms)

1.2.1.1 Capsules, hard shell Part I 47 of 58 records kept Process →
1.2.1.2 Capsules, soft shell Part I 38 of 46 records kept
1.2.1.3 Chewing gums Part I 38 of 46 records kept
1.2.1.4 Impregnated matrices Part I 38 of 46 records kept
1.2.1.5 Liquids for external use Part I · Annex 9 47 of 58 records kept Process →
1.2.1.6 Liquids for internal use Part I · Annex 9 47 of 58 records kept Process →
1.2.1.7 Medicinal gases Part I · Annex 6 52 of 60 records kept Process →
1.2.1.8 Other solid dosage forms Part I 47 of 58 records kept Process →
1.2.1.9 Pressurised preparations Part I · Annex 10 38 of 46 records kept
1.2.1.10 Radionuclide generators Part I · Annex 3 54 of 69 records kept Process →
1.2.1.11 Semi-solids Part I · Annex 9 47 of 58 records kept Process →
1.2.1.12 Suppositories Part I 38 of 46 records kept
1.2.1.13 Tablets Part I 47 of 58 records kept Process →
1.2.1.14 Transdermal patches Part I 38 of 46 records kept
1.2.1.15 Intraruminal devices —
1.2.1.16 Veterinary premixes —
1.2.1.17 Otherfree text Part I 38 of 46 records kept

1.2.2 Batch Certification Part I · Annex 16 39 of 47 records kept

1.3 Biological medicinal products16 operations · 8 written out as a processOpenClose

1.3.1 Biological medicinal products (list of product types)

1.3.1.1 Blood products Part I · Annex 2 · Annex 14 58 of 79 records kept Process →
1.3.1.2 Immunological products Part I · Annex 2 58 of 79 records kept Process →
1.3.1.3 Cell therapy products Part IV 24 of 34 records kept Process →
1.3.1.4 Gene therapy products Part IV 24 of 34 records kept Process →
1.3.1.5 Biotechnology products Part I · Annex 2 58 of 79 records kept Process →
1.3.1.6 Human or animal extracted products Part I · Annex 2 58 of 79 records kept Process →
1.3.1.7 Tissue engineered products Part IV 24 of 34 records kept Process →
1.3.1.8 Otherfree text Part I · Annex 2 58 of 79 records kept Process →

1.3.2 Batch certification (list of product types)

1.3.2.1 Blood products Part I · Annex 14 · Annex 16 39 of 47 records kept
1.3.2.2 Immunological products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.3 Cell therapy products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.4 Gene therapy products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.5 Biotechnology products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.6 Human or animal extracted products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.7 Tissue engineered products Part I · Annex 2 · Annex 16 49 of 70 records kept
1.3.2.8 Otherfree text Part I · Annex 2 · Annex 16 49 of 70 records kept

1.4 Other products or manufacturing activity10 operations · 1 written out as a processOpenClose

1.4.1 Manufacture of

1.4.1.1 Herbal products Part I · Annex 7 53 of 61 records kept Process →
1.4.1.2 Homoeopathic products Part I 38 of 46 records kept
1.4.1.3 Otherfree text Part I 38 of 46 records kept

1.4.2 Sterilisation of active substances/excipients/finished product

1.4.2.1 Filtration Part I · Annex 1 47 of 107 records kept
1.4.2.2 Dry heat Part I · Annex 1 47 of 107 records kept
1.4.2.3 Moist heat Part I · Annex 1 47 of 107 records kept
1.4.2.4 Chemical Part I · Annex 1 47 of 107 records kept
1.4.2.5 Gamma irradiation Part I · Annex 1 · Annex 12 47 of 107 records kept
1.4.2.6 Electron beam Part I · Annex 1 · Annex 12 47 of 107 records kept

1.4.3 Otherfree text Part I 38 of 46 records kept

1.5 Packaging18 operations · 8 written out as a processOpenClose

1.5.1 Primary packaging

1.5.1.1 Capsules, hard shell Part I 47 of 58 records kept Process →
1.5.1.2 Capsules, soft shell Part I 38 of 46 records kept
1.5.1.3 Chewing gums Part I 38 of 46 records kept
1.5.1.4 Impregnated matrices Part I 38 of 46 records kept
1.5.1.5 Liquids for external use Part I · Annex 9 47 of 58 records kept Process →
1.5.1.6 Liquids for internal use Part I · Annex 9 47 of 58 records kept Process →
1.5.1.7 Medicinal gases Part I · Annex 6 52 of 60 records kept Process →
1.5.1.8 Other solid dosage forms Part I 47 of 58 records kept Process →
1.5.1.9 Pressurised preparations Part I · Annex 10 38 of 46 records kept
1.5.1.10 Radionuclide generators Part I · Annex 3 54 of 69 records kept Process →
1.5.1.11 Semi-solids Part I · Annex 9 47 of 58 records kept Process →
1.5.1.12 Suppositories Part I 38 of 46 records kept
1.5.1.13 Tablets Part I 47 of 58 records kept Process →
1.5.1.14 Transdermal patches Part I 38 of 46 records kept
1.5.1.15 Intraruminal devices —
1.5.1.16 Veterinary premixes —
1.5.1.17 Otherfree text Part I 38 of 46 records kept

1.5.2 Secondary packaging Part I 38 of 46 records kept

1.6 Quality control testing4 operationsOpenClose

1.6.1 Microbiological: sterility Part I · Annex 8 38 of 46 records kept

1.6.2 Microbiological: non-sterility Part I · Annex 8 38 of 46 records kept

1.6.3 Chemical/Physical Part I · Annex 8 38 of 46 records kept

1.6.4 Biological Part I · Annex 8 38 of 46 records kept

2 · Importation of medicinal products

2.1 Quality control testing of imported medicinal products4 operationsOpenClose

2.1.1 Microbiological: sterility Part I · Annex 21 38 of 46 records kept

2.1.2 Microbiological: non-sterility Part I · Annex 21 38 of 46 records kept

2.1.3 Chemical/Physical Part I · Annex 21 38 of 46 records kept

2.1.4 Biological Part I · Annex 21 38 of 46 records kept

2.2 Batch certification of imported medicinal products11 operationsOpenClose

2.2.1 Sterile Products

2.2.1.1 Aseptically prepared Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.1.2 Terminally sterilised Part I · Annex 21 · Annex 16 39 of 47 records kept

2.2.2 Non-sterile products Part I · Annex 21 · Annex 16 39 of 47 records kept

2.2.3 Biological medicinal products

2.2.3.1 Blood products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.2 Immunological products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.3 Cell therapy products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.4 Gene therapy products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.5 Biotechnology products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.6 Human or animal extracted products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.7 Tissue engineered products Part I · Annex 21 · Annex 16 39 of 47 records kept
2.2.3.8 Otherfree text Part I · Annex 21 · Annex 16 39 of 47 records kept

2.3 Other importation activities4 operationsOpenClose

2.3.1 Site of physical importation Part I · Annex 21 38 of 46 records kept

2.3.2 Importation of intermediate which undergoes further processing Part I · Annex 21 38 of 46 records kept

2.3.3 Biological active substance Part I · Annex 21 38 of 46 records kept

2.3.4 Otherfree text Part I · Annex 21 38 of 46 records kept

3 · Manufacturing operations - active substances

3.1 Manufacture of Active Substance by Chemical Synthesis4 operationsOpenClose

3.1.1 Manufacture of active substance intermediates Part II 17 of 33 records kept

3.1.2 Manufacture of crude active substance Part II 17 of 33 records kept

3.1.3 Salt formation / Purification stepsfree text Part II 17 of 33 records kept

3.1.4 Otherfree text Part II 17 of 33 records kept

3.2 Extraction of Active Substance from Natural Sources7 operations · 1 written out as a processOpenClose

3.2.1 Extraction of substance from plant source Part II 41 of 57 records kept Process →

3.2.2 Extraction of substance from animal source Part II 17 of 33 records kept

3.2.3 Extraction of substance from human source Part II 17 of 33 records kept

3.2.4 Extraction of substance from mineral source Part II 17 of 33 records kept

3.2.5 Modification of extracted substancefree text Part II 17 of 33 records kept

3.2.6 Purification of extracted substancefree text Part II 17 of 33 records kept

3.2.7 Otherfree text Part II 17 of 33 records kept

3.3 Manufacture of Active Substance using Biological Processes5 operationsOpenClose

3.3.1 Fermentation Part II 17 of 33 records kept

3.3.2 Cell Culturefree text Part II 17 of 33 records kept

3.3.3 Isolation / Purification Part II 17 of 33 records kept

3.3.4 Modification Part II 17 of 33 records kept

3.3.5 Otherfree text Part II 17 of 33 records kept

3.4 Manufacture of sterile active substance2 operationsOpenClose

3.4.1 Aseptically prepared Part II · Annex 1 26 of 91 records kept

3.4.2 Terminally sterilised Part II · Annex 1 26 of 91 records kept

3.5 General Finishing Steps4 operationsOpenClose

3.5.1 Physical processing stepsfree text Part II 17 of 33 records kept

3.5.2 Primary Packaging (enclosing / sealing the active substance within a packaging material) Part II 17 of 33 records kept

3.5.3 Secondary Packaging (placing the sealed primary package within an outer packaging) Part II 17 of 33 records kept

3.5.4 Otherfree text Part II 17 of 33 records kept

3.6 Quality Control Testing4 operationsOpenClose

3.6.1 Physical / Chemical testing Part II 17 of 33 records kept

3.6.2 Microbiological testing (excluding sterility testing) Part II 17 of 33 records kept

3.6.3 Microbiological testing (including sterility testing) Part II 17 of 33 records kept

3.6.4 Biological Testing Part II 17 of 33 records kept

4 · Other activities - active substances

On the certificate this part carries no numbered operations: the authority writes it in as free text. Send us the wording and we will tell you which records follow from it.

Four parts, because the union format itself has four: manufacturing, importation, active substances, and other activities with active substances. Wording follows the blank published by the EMA, including the slots marked “free text”, which the authority fills in words. Wholesale distribution is a certificate of its own and is not part of this format. A record type is one thing a clause asks a site to record; the counts show what our catalogue maps and builds, not a share of the regulation.

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