What characterizes a label for Investigational Medical Products (IMPs)?
Booklet Label
For Clinical Trials
In the case of investigational medicinal products, the labeling must ensure the protection of individuals and traceability, enable the identification of the medicinal product and the trial, and ensure proper use of the medicinal product. Mandatory labels are defined in Annex XIII of the EU Good Manufacturing Practice (GMP) – principles for the manufacturing of investigational medicinal products (IMPs). Similar provisions are laid down in the US GMP and PIC/S GMP for Asia.
All information must be available in a legible and generally understandable manner in the respective official language of the participating countries and must be nonswitched permanently to the packaging of the medication.
Why booklet labels in clinical trials?
The ISPE Good Practice Guide recommends a font size of 9 pts for mandatory texts, the FDA 10 pts. Booklet labels provide suitable space for this and therefore help to increase quality and patient safety.
Faubel-Compact® Label
The Faubel-Compact® Label is particularly suitable for labeling multilingual clinical trials. With up to 113 pages of content, the Faubel-Compact® Label offers sufficient space for longer text. Booklet labels greatly simplify processes and logistics in clinical trial labeling. All the countries participating in such trials can join right from the start. IMPs are stored in regional depots and are immediately available when needed.
Booklet Labels in any shape
We find the perfect design for every container. Our booklet labels are adapted by our product development to the shape of the packaging and tested according to criteria of functionality and handling. Thus, a multi-paged Faubel-Compact® Label can be fit to inhalers and the smallest of tubes.
For Biologics and Vaccines
The global market for biologics is booming. The demand for vaccines is also increasing. When it comes to biologics and vaccines, manufacturers and suppliers need to be more efficient and flexible than ever, just like Faubel is. Together with our customers, we can deliver high performance and meet existing challenges no matter how complex their structure is.
Wrap Around Label
For small containers, such as syringes or vials, the Faubel-Wrap Around Label is recommended. As a booklet or single-layer label, the Wrap Around Label can also be designed with single or multiple documentation stickers. Even small vials with vaccines can be labeled in this way, including the batch labels, depending on the number of individual doses that can be removed. This makes vaccine documentation in practice safe, error-free and simple.
What kind of label does your clinical trial need?
Our project management team is looking forward to your inquiry.
Our Services:
Faubel Pharma Services is an excellent partner specialized in the labeling of clinical trials. We have grown from being a label manufacturer into a multi-service provider along the clinical trial supply chain.
Label Design & Routing
Supported by experienced clinical trial project managers, our large team of dedicated clinical labeling experts focuses on services that give our customers more flexibility and help shorten timelines. We maintain the human resources needed to cover peak demand and function as a backup.
Overprinting
Overprinting involves the subsequent printing of variable data on pre-produced bulk goods. We take care of the complete data preparation using validated software. UV inkjet printing systems with two independent 100% camera controls guarantee correct printing results.
Blinding Solutions
Faubel develops individual concepts for blinding any kind of container. We mainly design blinding as labels (single-layer, multilayer or booklet labels) or blinding boxes. We have successfully blinded vials, tubes, bottles, blisters or syringes or even components like syringe caps.
Smart Label Solutions
Our aim is to develop labels that bring benefits to the user and optimize the pharmaceutical supply chain. RFID leads to a gain in efficiency by reducing errors, replacing manual jobs and speeding up processes. Integrated RFID solutions are used in track & trace applications, time-temperature monitoring or to support patient compliance.
Folding Boxes
Folding boxes complement Faubel‘s product and service portfolio. The design focuses on folding boxes with customized inlays. These custom-fit elements are used to place, secure, and protect products inside kits.
