07.12.2017
Procedure for discrepancies between EU and PIC/S GMP
According to Annex 1, letters c and d, of the Medicinal Products Licensing Ordinance (MPLO), the Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use issued by the European Commission (EudraLex, Volume 4), referred to as EU GMP, and the Guide to Good Manufacturing Practice for medicinal products stipulated in the Convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products of 8 October 1970, known as PIC/S GMP, both of which regulate Good Manufacturing Practice internationally, are valid in Switzerland. This means that the compliance with Good Manufacturing Practice stipulated in Article 4, para. 2 MPLO as a condition for acquiring a manufacturing license from the Agency requires compliance with the conditions of both the GMP regulations stated above.
Efforts are being made internationally to harmonise the two sets of guidelines in the near future through close coordination between the EU authorities and the PIC/S committees. Yet in many cases it is not possible to implement updates simultaneously. The two sets of guidelines are nonetheless equivalent even if they are not identical in all respects. This, however, does not release manufacturers from the obligation to observe both sets of guidelines at all times. Where there are discrepancies between the sets of guidelines, compliance with both sets can in fact only be guaranteed if the more stringent requirements of the two are observed. This generally means that the EU GMP guidelines, which usually enter into force slightly earlier, are definitive.
Against this background, the practice also tolerated by the Agency in some situations of considering compliance with PIC/S GMP only (which is sometimes transiently less stringent or less up-to-date) as sufficient to meet the requirements stipulated in Art. 4, para. 2 MPLO cannot be maintained. This is clear not least in the context of the most recent updates of EU GMP concerning requirements to avoid contamination risks. These are of great material importance and must accordingly be fulfilled if manufacture is to represent the current state of science and technology (see Art. 3 Therapeutic Products Act, TPA).
The general view stated in the introduction to both sets of GMP guidelines that a manufacturer may adopt approaches other than those described in the guidelines in order to achieve an equivalent (or better) level of quality assurance is not affected by the above comments. During inspections the quality assurance system and GMP compliance will continue to be reviewed on the basis of the aspects mentioned above.