EU GDP Guidelines now official in Switzerland
On 8 September 2013 the Guidelines on Good Distribution Practice of medicinal products for human use became effective in the EU Member States.
It was unclear for a long time what validity these Guidelines have in Switzerland, as a non-EU state. Within the framework of the agreement between the Swiss Confederation and the European Community on Mutual Recognition Agreements (MRA) Switzerland has committed to respect European principles of law as far as they include GMP regulations. Thus, the GMP regulations of the relevant directives such as 2001/83/EC also apply.
For the EU-GDP Guidelines, the Swiss Federal Office of Public Health (Bundesamt für Gesundheit, BAG) recommended that in particular internationally active companies with corresponding Swissmedic approval should already implement the new GDP Guidelines as far as the current applicable GDP Guidelines defined in Annex 2 of the AMBV are still met.
Now the Federal Department of the Interior has implemented the EU-GDP Guidelines, through the adaptation of Annex 2 of the Medicinal Products Approval Regulation (AMBV). The adjustments became effective on July 1, 2015 - with a planned implementation period of six months.
The implementation as well as the definition of possibly needed technical directives is now up to the SwissMedic.
Ordinance for authorisation of medicinal products, update of 10 Jun 2015
ISO 9001 Quality Management Systems Revision
ISO 9001, the world's leading quality management standard, is under revision, with an updated version (ISO 9001:2015) due by the end of 2015. The International Organisation for Standardization (ISO) has planned this way to give a uniform structure to all management standards. Therefore, the chapters of all norms for Management Systems will be organised with the same chapters, and terms and meanings will be adapted in order to standardize the language used. This will bring to a simplification of the integration of all the management systems in an organisation. The new structure has no influence on the description of the quality management system, but the new requirements are stronger process-oriented and more emphasis is given to a risk based approach.
Organisations already ISO 9001:2008 certified are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.
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