PATHEON UK LIMITED – MIA 17857

1.1 — Sterile Products

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

1.1.1.2 — Lyophilisates

1.1.1.4 — Small volume liquids

1.1.1.6 — Other aseptically prepared products

1.1.2 — Terminally Sterilised (processing operations for the following dosage forms)

1.1.2.3 — Small volume liquids

1.1.2.5 — Other terminally sterilised prepared products

1.1.3 — Batch certification

1.3 — Biological medicinal products

1.3.1 — Biological medicinal products

1.3.1.1 — Blood products

1.3.1.2 — Immunological products

1.3.1.4 — Gene therapy products

1.3.1.5 — Biotechnology products

1.3.1.6 — Human or animal extracted products

1.3.2 — Batch certification

1.3.2.2 — Immunological products

1.4 — Other products or manufacturing activity

1.4.2 — Sterilisation of active substances/excipients/finished products:

1.4.2.1 — Filtration

1.4.2.3 — Moist heat

1.5 — Packaging

1.5.2 — Secondary packaging

1.6 — Quality control testing

1.6.1 — Microbiological: sterility

1.6.2 — Microbiological: non-sterility

1.6.3 — Chemical/Physical

1.6.4 — Biological

2.1 — Quality control testing of imported medicinal products

2.1.1 — Microbiological: sterility

2.1.2 — Microbiological: non-sterility

2.1.3 — Chemical/Physical

2.1.4 — Biological

2.2 — Batch certification of imported medicinal products

2.2.1 — Sterile Products

2.2.1.1 — Aseptically prepared

2.2.1.2 — Terminally sterilised

2.2.2 — Non-sterile products

2.2.3 — Biological medicinal products

2.2.3.2 — Immunological products

2.2.3.4 — Gene therapy products

2.2.3.5 — Biotechnology products

2.2.3.6 — Human or animal extracted products