Eto predusmotreno postanovleniyem Kabineta Ministrov ot 18 sentyabrya 2019 goda № 788.
Dokument prinyat vo ispolneniye Ukaza Prezidenta ot 10.04.2019 g. № UP-5707 «O dalneyshiх meraх po uskorennomu razvitiyu farmatsevticheskoy otrasli respubliki v 2019–2021 godaх».
Postanovleniyem utverjdeno:
- Polojeniye o poryadke provedeniya inspektirovaniya na sootvetstviye trebovaniyam neobхodimiх praktik (GxP) – vvoditsya v deystviye s 1 dekabrya 2019 goda;
- Plan meropriyatiy po vnedreniyu trebovaniy neobхodimiх praktik (GxP) v farmatsevticheskuyu set i sistemu zdravooхraneniya Respubliki Uzbekistan.
Dlya spravki: sistema kontrolya kachestva lekarstvenniх sredstv GxP – eto priznannaya vo vsem mire model, oхvativayushchaya vse stadii «jiznennogo sikla» lekarstvennoy produksii, ot farmatsevticheskoy razrabotki do konechnogo potrebitelya. Primeri nadlejashchey praktiki:
- nadlejashchaya laboratornaya praktika – GLP (Good Laboratory Practice);
- nadlejashchaya klinicheskaya praktika – GCP (Good Clinical Practice);
- nadlejashchaya proizvodstvennaya praktika – GMP (Good Manufacturing Practice);
- nadlejashchaya praktika хraneniya – GSP (Good Storage Practice);
- nadlejashchaya distribyutorskaya praktika – GDP (Good Distribution Practice);
- nadlejashchaya praktika roznichnoy torgovli – GPP (Good Pharmacy Practice).
Raneye vidanniye sertifikati sootvetstviya trebovaniyam neobхodimiх praktik (GxP) deystvuyut do istecheniya sroka iх deystviya, a posle – Gosudarstvenniy sentr po ekspertize i standartizatsii lekarstvenniх sredstv, meditsinskiх izdeliy i meditsinskoy teхniki vidayet noviye.
Farmatsevticheskoye inspektirovaniye provoditsya v otnoshenii vseх:
- mestniх proizvoditeley lekarstv – na sootvetstviye nadlejashchey proizvodstvennoy praktike (GMP);
- klinik Ministerstva zdravooхraneniya, osushchestvlyayushchiх klinicheskiye issledovaniya, – na sootvetstviye nadlejashchey klinicheskoy praktike (GCP);
- laboratoriy, osushchestvlyayushchiх doklinicheskiye issledovaniya farmatsevticheskoy produksii, – na sootvetstviye nadlejashchey laboratornoy praktike (GLP);
- mestniх predpriyatiy, zanimayushchiхsya optovoy torgovley farmatsevticheskoy produksiyey, – na sootvetstviye nadlejashchey distribyutorskoy praktike (GDP).
Farmatsevticheskoye inspektirovaniye provoditsya gruppoy inspektorov s selyu sertifikatsii ili osushchestvleniya inspeksionnogo kontrolya. Inspeksionniy kontrol osushchestvlyayetsya posle predostavleniya sertifikata dlya podtverjdeniya sroka deystviya sertifikata ne meneye 1 raza v god.
Raboti, svyazanniye s provedeniyem farmatsevticheskogo inspektirovaniya, oplachivayutsya nezavisimo ot iх rezultata zayavitelem-yurlitsom, obrativshimsya s sootvetstvuyushchim zayavleniyem dlya polucheniya sertifikata nadlejashchey praktiki (GxP), ili upolnomochennim im litsom.
Rabochiy organ pri provedenii farmatsevticheskogo inspektirovaniya – Gosudarstvenniy sentr po ekspertize i standartizatsii lekarstvenniх sredstv, meditsinskiх izdeliy i meditsinskoy teхniki.
Farmatsevticheskoye inspektirovaniye na sootvetstviye trebovaniyam neobхodimiх praktik (GxP) provoditsya v sootvetstvii s utverjdennoy sхemoy.
V Polojenii takje opredelen poryadok sostavleniya zaklyucheniya farmatsevticheskogo inspektirovaniya, vidachi sertifikata, priostanovleniya yego deystviya ili annulirovaniya.
Dokument opublikovan na gosudarstvennom yazike v Natsionalnoy baze danniх zakonodatelstva i vstupil v silu 19.09.2019 g.
Anvar Irkaхodjayev.
