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 represent the Swiss Medicines Inspectorate (SMI) current interpretation on certain GMP- / GDP-topics. The Technical Interpretations (TI) are intended to assure a harmonized inspection practice within the SMI. They do not create or confer any rights or obligations for or on any person and do not operate to bind SMI or the companies inspected. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.