All CRS units are able to satisfactorily handle trial medication, either investigational medicinal products (IMPs) or marketed reference products, pursuant to Section 13 AMG.
CRS offers CTSM services such as:
- Primary packaging and labelling of all solid, semi-solid and liquid dosage forms (e.g. tablets, capsules, gels, cremes and solutions (oral & i.v.), TTS) as stated in the manufacturing license.
- Randomisation of individual trial packs, preparation of individual trial medication for Phase I – III studies (small sample sizes are also possible).
Our well trained staff dedicated to the GMP area is able to manage all kinds of trial medication (including check after receipt, storage, manufacturing steps, QP release, dispensation for administration, drug accountability and return / destruction) according to the regulatory requirements.
CRS guarantees QP release of trial medication according to GMP rules (e.g. EudraLex – Vol. 4, PharmBetrV, and EU Clinical Trials Directive 2001/20/EC).
- Trial medication handling and storage
As a unique feature, our facility in Mönchengladbach has been licensed since 2004 and is in possession of an almost unrestricted manufacturing license in accordance with GMP rules.
Access to the GMP area is restricted to authorised and specifically trained personnel. Trial medication is checked after receipt and placed in the storage room by GMP associated staff and kept in locked steel cabinets or refrigerators with classification areas as follows: ‘Quarantine’, ‘Free for use’ or ‘Barred’.
The air-conditioned GMP area is monitored every working day. Temperature and humidity are recorded by a data logger which activates a central alarm if the temperature deviates beyond a set limit. Thorough accountability is performed for all trial medications.
The production room is designed according to clean room standards. The GMP area and related equipment is re-validated annually by external specialists.
For CRS-Mannheim and CRS-Kiel all manufacturing operations concerning trial medications are subcontracted to cooperation partners who are located in close vicinity of the clinical sites. This enables preparation and immediate drug administration especially of drugs with a short stability range. Our facility in Mannheim is working together with the partner “Fortuna Herstellung GmbH” and our unit in Kiel is cooperating with the pharmacy of the University Hospital Kiel.
All in-house or partner based manufacturing licenses allow manufacturing of sterile products (e.g. large volume liquids, semi-solids, small volume liquids, aseptically prepared or terminally sterilised), non-sterile products (e.g. capsules, liquids, other solid or semi-solid dosage forms).
A copy of manufacturing licenses can be sent to sponsor, if requested.
GMP related Links: