{"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\/sk\/grundlagen-guide\/pharma-und-lebensmittelkonformitaet\/","title":{"rendered":"Farmaceutick\u00e1 a potravinov\u00e1 zhoda"},"content":{"rendered":"
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Syst\u00e9my a stroje, ktor\u00e9 sa pou\u017e\u00edvaj\u00fa pri spracovan\u00ed farmaceutick\u00fdch v\u00fdrobkov alebo potrav\u00edn alebo vo v\u0161eobecnosti v hygienicky kritick\u00fdch prostrediach, musia sp\u013a\u0148a\u0165 ur\u010dit\u00e9 krit\u00e9ri\u00e1. Tie s\u00fa v Eur\u00f3pe definovan\u00e9 aspo\u0148 pre potravin\u00e1rsky sektor:<\/p>\n

ES1935\/2004 - v\u0161eobecn\u00e9 nariadenie<\/h4>\n

Eur\u00f3psky parlament vydal v roku 2004 nariadenie ES1935\/2004. Nahr\u00e1dza smernice 80\/590\/EHS a 89\/109\/EHS. Cie\u013eom tohto nariadenia je chr\u00e1ni\u0165 spotrebite\u013eov pred zdravotn\u00fdmi rizikami. T\u00fdka sa predov\u0161etk\u00fdm potrav\u00edn, ale v praxi sa \u010dasto uplat\u0148uje aj na in\u00e9 citliv\u00e9 aplik\u00e1cie, ako je napr\u00edklad v\u00fdroba farmaceutick\u00fdch v\u00fdrobkov.<\/p>\n

Preto musia by\u0165 materi\u00e1ly, ktor\u00e9 prich\u00e1dzaj\u00fa do styku s potravinami, vyroben\u00e9 tak, aby \u201eza be\u017en\u00fdch alebo predv\u00eddate\u013en\u00fdch podmienok pou\u017e\u00edvania nepren\u00e1\u0161ali zlo\u017eky do potrav\u00edn v mno\u017estv\u00e1ch, ktor\u00e9 by mohli sp\u00f4sobi\u0165<\/p>\n

ohrozuj\u00fa \u013eudsk\u00e9 zdravie;
\nsp\u00f4sobi\u0165 neprijate\u013en\u00fa zmenu zlo\u017eenia potraviny;
\nsp\u00f4sobi\u0165 zhor\u0161enie organoleptick\u00fdch vlastnost\u00ed potrav\u00edn (pozn. redakcie: ako s\u00fa v\u00f4\u0148a, chu\u0165, vzh\u013ead, farba at\u010f.).\u201c
\nTo tie\u017e znamen\u00e1, \u017ee ozna\u010dovanie, reklama a prezent\u00e1cia materi\u00e1lov a predmetov nesmie zav\u00e1dza\u0165 spotrebite\u013ea.<\/p>\n

Okrem v\u0161eobecn\u00e9ho nariadenia obsahuje nariadenie ES1935\/2004 inform\u00e1cie o jednotliv\u00fdch opatreniach, jednotliv\u00fdch vn\u00fatro\u0161t\u00e1tnych opatreniach, autoriz\u00e1cii l\u00e1tok a ozna\u010dovan\u00ed pri uv\u00e1dzan\u00ed na trh.<\/p>\n

Vyhl\u00e1senie o zhode<\/h4>\n

K pr\u00edslu\u0161n\u00fdm materi\u00e1lom a predmetom mus\u00ed by\u0165 prilo\u017een\u00e9 p\u00edsomn\u00e9 vyhl\u00e1senie, \u017ee s\u00fa v s\u00falade s platn\u00fdmi predpismi. V pr\u00edpade potreby to mus\u00ed by\u0165 mo\u017en\u00e9 preuk\u00e1za\u0165 aj vhodnou dokument\u00e1ciou.<\/p>\n

Vysledovate\u013enos\u0165<\/h4>\n

S cie\u013eom u\u013eah\u010di\u0165 kontroly a stiahnutie chybn\u00fdch v\u00fdrobkov z trhu musia by\u0165 dod\u00e1vate\u013esk\u00e9 re\u0165azce vysledovate\u013en\u00e9 prostredn\u00edctvom syst\u00e9mov alebo postupov.<\/p>\n

Symbol zhody potrav\u00edn<\/p>\n

Smernica FDA o potravin\u00e1ch<\/h3>\n

Smernica FDA o bezpe\u010dnosti potrav\u00edn sa vz\u0165ahuje v\u00fdlu\u010dne na materi\u00e1ly a predmety dov\u00e1\u017ean\u00e9 do USA. FDA (Food and Drug Administration) je org\u00e1n zodpovedn\u00fd za doh\u013ead nad trhom s potravinami, liekmi a zdravotn\u00edckymi pom\u00f4ckami v USA. Hoci sa v Eur\u00f3pe samozrejme pr\u00e1vne neuplat\u0148uje, pre mnoh\u00e9 eur\u00f3pske spolo\u010dnosti zohr\u00e1va \u00falohu vzh\u013eadom na v\u00fdznam americk\u00e9ho trhu. Je samozrejm\u00e9, \u017ee eur\u00f3pske spolo\u010dnosti v USA musia dodr\u017eiava\u0165 rovnak\u00e9 usmernenia ako americk\u00e9 spolo\u010dnosti.<\/p>\n

\u00darad FDA preto ur\u010duje, ktor\u00e9 pom\u00f4cky, v\u00fdrobky, materi\u00e1ly at\u010f. m\u00f4\u017eu pr\u00eds\u0165 do styku s potravinami, a kontroluje dodr\u017eiavanie t\u00fdchto predpisov. Pokia\u013e ide o krit\u00e9ri\u00e1, ktor\u00e9 sa maj\u00fa splni\u0165, plat\u00ed rovnak\u00fd princ\u00edp ako v pr\u00edpade ES 1935\/2004.<\/p>\n

Rovnak\u00fa \u00falohu zohr\u00e1va v \u010c\u00edne aj N\u00e1rodn\u00fd \u00farad pre zdravotn\u00edcke v\u00fdrobky (NMPA).<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t

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Symbol zhody potrav\u00edn<\/p>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t\n\t

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