Airpharm ISO 9001:2015

We are proud to announce the recertification of our company according to the ISO 9001:2015 Norm.

 

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.

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