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.
Directives are basic terms of reference for inspectorates in accordance with Article 63 MPLO (SR 818.212.1). They guarantee uniform inspection procedures throughout Switzerland and are terms of reference for any standard operating procedures for the inspectorates.
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.
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.