{"id":10820,"date":"2024-09-09T05:44:20","date_gmt":"2024-09-09T03:44:20","guid":{"rendered":"https:\/\/shop.ptm-mechatronics.com\/stage\/?post_type=grundlagen-guide&p=10820"},"modified":"2024-10-07T08:56:29","modified_gmt":"2024-10-07T06:56:29","slug":"pharma-und-lebensmittelkonformitaet","status":"publish","type":"grundlagen-guide","link":"https:\/\/ptm-mechatronics.com\/cs\/grundlagen-guide\/pharma-und-lebensmittelkonformitaet\/","title":{"rendered":"Farmaceutick\u00e1 a potravin\u00e1\u0159sk\u00e1 shoda"},"content":{"rendered":"
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Syst\u00e9my a stroje, kter\u00e9 se pou\u017e\u00edvaj\u00ed p\u0159i zpracov\u00e1n\u00ed farmaceutick\u00fdch v\u00fdrobk\u016f nebo potravin nebo obecn\u011b v hygienicky kritick\u00fdch prost\u0159ed\u00edch, mus\u00ed spl\u0148ovat ur\u010dit\u00e1 krit\u00e9ria. Ta jsou v Evrop\u011b definov\u00e1na p\u0159inejmen\u0161\u00edm pro potravin\u00e1\u0159sk\u00fd sektor:<\/p>\n

ES1935\/2004 - obecn\u00e9 na\u0159\u00edzen\u00ed<\/h4>\n

Evropsk\u00fd parlament vydal v roce 2004 na\u0159\u00edzen\u00ed ES1935\/2004. Nahrazuje sm\u011brnice 80\/590\/EHS a 89\/109\/EHS. \u00da\u010delem tohoto na\u0159\u00edzen\u00ed je chr\u00e1nit spot\u0159ebitele p\u0159ed zdravotn\u00edmi riziky. T\u00fdk\u00e1 se p\u0159edev\u0161\u00edm potravin, ale v praxi se \u010dasto uplat\u0148uje i v jin\u00fdch citliv\u00fdch oblastech, nap\u0159\u00edklad p\u0159i v\u00fdrob\u011b farmaceutick\u00fdch v\u00fdrobk\u016f.<\/p>\n

Materi\u00e1ly, kter\u00e9 p\u0159ich\u00e1zej\u00ed do styku s potravinami, proto mus\u00ed b\u00fdt vyrobeny tak, aby \u201eza b\u011b\u017en\u00fdch nebo p\u0159edv\u00eddateln\u00fdch podm\u00ednek pou\u017eit\u00ed nep\u0159en\u00e1\u0161ely do potravin slo\u017eky v mno\u017estv\u00ed, kter\u00e9 by mohlo zp\u016fsobit jejich po\u0161kozen\u00ed\".<\/p>\n

ohro\u017euj\u00ed lidsk\u00e9 zdrav\u00ed;
\nzp\u016fsobit nep\u0159ijatelnou zm\u011bnu slo\u017een\u00ed potraviny;
\nzp\u016fsobuj\u00ed zhor\u0161en\u00ed organoleptick\u00fdch vlastnost\u00ed potravin (pozn. redakce: jako je v\u016fn\u011b, chu\u0165, vzhled, barva atd.).\u201c
\nTo tak\u00e9 znamen\u00e1, \u017ee ozna\u010dov\u00e1n\u00ed, reklama a prezentace materi\u00e1l\u016f a p\u0159edm\u011bt\u016f nesm\u00ed uv\u00e1d\u011bt spot\u0159ebitele v omyl.<\/p>\n

Krom\u011b obecn\u00e9ho na\u0159\u00edzen\u00ed obsahuje ES1935\/2004 informace o jednotliv\u00fdch opat\u0159en\u00edch, jednotliv\u00fdch vnitrost\u00e1tn\u00edch opat\u0159en\u00edch, povolov\u00e1n\u00ed l\u00e1tek a ozna\u010dov\u00e1n\u00ed p\u0159i uv\u00e1d\u011bn\u00ed na trh.<\/p>\n

Prohl\u00e1\u0161en\u00ed o shod\u011b<\/h4>\n

K doty\u010dn\u00fdm materi\u00e1l\u016fm a p\u0159edm\u011bt\u016fm mus\u00ed b\u00fdt p\u0159ilo\u017eeno p\u00edsemn\u00e9 prohl\u00e1\u0161en\u00ed, \u017ee jsou v souladu s platn\u00fdmi p\u0159edpisy. V p\u0159\u00edpad\u011b pot\u0159eby to mus\u00ed b\u00fdt mo\u017en\u00e9 dolo\u017eit vhodnou dokumentac\u00ed.<\/p>\n

Sledovatelnost<\/h4>\n

Aby bylo mo\u017en\u00e9 usnadnit kontroly a sta\u017een\u00ed vadn\u00fdch v\u00fdrobk\u016f z trhu, mus\u00ed b\u00fdt dodavatelsk\u00e9 \u0159et\u011bzce sledovateln\u00e9 prost\u0159ednictv\u00edm syst\u00e9m\u016f nebo postup\u016f.<\/p>\n

Symbol shody potravin<\/p>\n

Sm\u011brnice FDA o potravin\u00e1ch<\/h3>\n

Sm\u011brnice FDA o bezpe\u010dnosti potravin se vztahuje v\u00fdhradn\u011b na materi\u00e1ly a p\u0159edm\u011bty dov\u00e1\u017een\u00e9 do USA. \u00da\u0159ad FDA (Food and Drug Administration) je org\u00e1nem odpov\u011bdn\u00fdm za dozor nad trhem s potravinami, l\u00e9ky a zdravotnick\u00fdmi prost\u0159edky v USA. A\u010dkoli v Evrop\u011b samoz\u0159ejm\u011b nen\u00ed pr\u00e1vn\u011b pou\u017eiteln\u00e1, hraje pro mnoho evropsk\u00fdch spole\u010dnost\u00ed roli vzhledem k v\u00fdznamu americk\u00e9ho trhu. Je samoz\u0159ejm\u00e9, \u017ee evropsk\u00e9 spole\u010dnosti v USA mus\u00ed dodr\u017eovat stejn\u00e9 sm\u011brnice jako americk\u00e9 spole\u010dnosti.<\/p>\n

\u00da\u0159ad FDA proto ur\u010duje, kter\u00e9 p\u0159\u00edstroje, v\u00fdrobky, materi\u00e1ly atd. mohou p\u0159ij\u00edt do styku s potravinami, a kontroluje dodr\u017eov\u00e1n\u00ed t\u011bchto p\u0159edpis\u016f. Pokud jde o krit\u00e9ria, kter\u00e1 je t\u0159eba splnit, plat\u00ed stejn\u00fd princip jako u ES 1935\/2004.<\/p>\n

Stejnou roli hraje v \u010c\u00edn\u011b N\u00e1rodn\u00ed \u00fa\u0159ad pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (NMPA).<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t

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Symbol shody potravin<\/p>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t\n\t

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