Airpharm registered in a European CTD as repackaging site for an API
On 08.05.2018 Airpharm has been officially registered as repackaging site of an API used for the production of a human medicinal product.
Name and address of Airpharm are reported in the Common Technical Document approved by the Health Authority.
Inspections: Switzerland changes Conditions
The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. This refers both to inspections by foreign authorities in Switzerland and inspections by the Swiss authority abroad.
This means that, starting from 1 January 2018:
- An inspection by a foreign authority is possible if the company agrees with the inspection (approval by SECO is no longer required for that). This requires direct contact between the Swiss company to be inspected and the foreign authority as a consequence.
- Swissmedic must be informed in advance that an inspection is planned by a foreign inspectorate. The company will be informed in time by Swissmedic in case the inspection will be accompanied.
- After the inspection, the inspection report should be made available to Swissmedic.
REACH Registration of Substances
In Mai 2018 the transitional period for REACH registration will come to an end. From this moment on all substances (with certain exceptions) will have to bear a REACH number. This information must be communicated in the Safety Data Sheet.
The manufacturers have to clarify with regard to the REACH registration status, whether their active ingredients are and remain marketable.
New cold storage facilities
In October 2017 we started the second part of our facilities revamping: after the installation of a new room temperature warehouse with a 5000 pallets capacity, we are now building new cold storage space for life science products, in order to offer additional services.
Starting from July 2018 the following cold storage facilities will be available:
- a 400 m2 Freezing Room at -20°C with a storage capacity of 300 pallets
- a 800 m2 Cool room at +5°C with a storage capacity of 700 pallets
Should you need any further detail or information, feel free to contact us.