Certain legal references within GMP/GDP documents have yet to be updated following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the fourth package of ordinances on therapeutic products on 1 January 2019. The process of updating them is in progress. Despite this, their content remains valid and unaltered.
The inspectorates are bound by guidelines. The guidelines often relate to procedures, are administrative in nature, occasionally supplement directives issued in accordance with Article 63 MPLO (SR 818.212.1) or may prescribe local working instructions for the inspectorates.
Guidelines are instructions for inspectorates. They are often related to procedures or are of an administrative nature, and may complete directives in accordance with Art. 63 of the Establishment Licences ordinance (ELO) and serve as instructions for any local working procedures for the inspectorates.
Technical Interpretations (TI)
These documents describe the requirements on individual GMP/GDP topics taking account of the specific legal provisions of therapeutic products legislation. The technical interpretations (TI) are intended primarily for administrative bodies and ensure the harmonisation of inspections practice among GMP/GDP inspectorates in Switzerland as well as the uniform and equitable application of the legal provisions. The publication of the TI provides clear information to licence holders concerning the requirements that they must fulfil in order to conduct their activities in compliance with GMP/GDP.