Clinical Trial Supply Management (CTSM) and handling of Investigational Medicinal Products (IMPs)

All CRS units are equipped to adequately handle Investigational Medicinal Products (IMPs). CRS-Kiel have facilities for adequate storing IMPs according to GMP. CRS-Mönchengladbach and CRS-Mannheim are staffed with qualified persons according to §14 AMG (German Drug Law), GMP certified and licensed for:

• Primary packaging and labeling of all solid and liquid dosage forms (e.g. tablets, capsules, solutions) as stated in manufacturing license acc. to §13 AMG (German Drug Law)
• Packaging and labeling of all dosage forms (e.g. injection solutions, ointments, transdermal delivery systems)
• Randomisation of individual trial packs, preparation of individual medication for Phase I studies
• Release of IMP’s acc. to GMP rules (EudraLex - Vol. 4 Annex 13 / 16) and §7 PharmBetrV, certification according to EU Directive 2001 / 20 / E C, Article 13(3)

The Mönchengladbach unit has been licensed since 2004. Since 2006 Mannheim has been licensed for the manufacturing of injection /
infusion solutions, eye-drops acc. to GMP rules (EudraLex Vol. 4 Annex 1) including randomisation of individual trial packs in cooperation with
a local nearby pharmacy in Mannheim.

The storage facilities are temperature and humidity controlled via automatic device, connected to an alarm system and checked every working day.