The 18 references with contexts in paper A. Gryzodub I., А. Гризодуб И. (2018) “Научные аспекты разработки Государственной фармакопеи Украины // Scientific aspects of the development of the State Pharmacopoeia of Ukraine” / spz:neicon:vedomostincesmp:y:2016:i:2:p:19-25

1
The State Pharmacopoeia of the USSR. 11th ed. Vol. 1 and 2. Moscow: Meditsina; 1987, 1990 (in Russian).
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    ÷àùåé åâðîïåéñêîé, íî îòðàæàþùåé íàöèîíàëüíûåîñîáåííîñòèÓêðàèíû.Êðîìåòîãî,èìåþòñÿ è ÷èñòî íàöèîíàëüíûå ñòàòüè, íàïðèìåð, 5.3.N.1.«Ñòàòèñòè÷åñêèéàíàëèçðåçóëüòàòîâõèìè÷åñêîãî ýêñïåðèìåíòà» [2, 3]. Äàííûé ôîðìàò ñòàòåé àíàëîãè÷åí Áðèòàíñêîé ôàðìàêîïåå è ÿâëÿåòñÿ î÷åíü ãèáêèì íà ïåðåõîäíîì ýòàïå ðàçðàáîòêè ÃÔÓ. Íàöèîíàëüíûå òðåáîâàíèÿ (â êà÷åñòâå êîòîðûõ ÷àñòî âûñòóïàëè òðåáîâàíèÿ ÃÔ ÑÑÑÐ XI
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    ), ïîçâîëÿëè ñìÿã÷èòü èëè óæåñòî÷èòü òðåáîâàíèÿ ÅÔ, à òàêæå îòñðî÷èòü èõ ââåäåíèå.  êà÷åñòâå ïðèìåðà ìîæíî ïðèâåñòè îáùóþ ñòàòüþ 2.9.7. «Èñòèðàåìîñòü òàáëåòîê áåç îáîëî÷êè». Òðåáîâàíèÿ Åԗ1 %èñòèðàåìîñòèè1-ëîïàñòíûéáàðàáàí.

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    Íàöèîíàëüíûå òðåáîâàíèÿ (â êà÷åñòâå êîòîðûõ ÷àñòî âûñòóïàëè òðåáîâàíèÿ ÃÔ ÑÑÑÐ XI [1]), ïîçâîëÿëè ñìÿã÷èòü èëè óæåñòî÷èòü òðåáîâàíèÿ ÅÔ, à òàêæå îòñðî÷èòü èõ ââåäåíèå.  êà÷åñòâå ïðèìåðà ìîæíî ïðèâåñòè îáùóþ ñòàòüþ 2.9.7. «Èñòèðàåìîñòü òàáëåòîê áåç îáîëî÷êè». Òðåáîâàíèÿ Åԗ1 %èñòèðàåìîñòèè1-ëîïàñòíûéáàðàáàí.Òðåáîâàíèÿ ÃÔ ÑÑÑÐ XI
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    — 3 % èñòèðàåìîñòè è 12-ëîïàñòíûé áàðàáàí.  íàöèîíàëüíîé ÷àñòè ÃÔÓ 1.0 (2001 ã.) áûëî ââåäåíî ðàçðåøåíèå èñïîëüçîâàòü 12-ëîïàñòíûé áàðàáàí, à â ÃÔÓ 1.1 (2004 ã.) ýòà íàöèîíàëüíàÿ ÷àñòü áûëà èñêëþ÷åíà. b.

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    Ìîíîãðàôèè íà ðàñòèòåëüíîå ñûðüå Íà ìîìåíò ââåäåíèÿ ÃÔÓ 1 â Óêðàèíå îòñóòñòâîâàëè (îíè è ñåé÷àñ íå ÿâëÿþòñÿ îáÿçàòåëüíûìè) òðåáîâàíèÿ Good Agricultural and Collection Practices (GACP)íàëåêàðñòâåííîåðàñòèòåëüíîåñûðüå(ËÐÑ). ËÐÑ êîíòðîëèðîâàëîñü ïî ÃÔ ÑÑÑÐ XI
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    , òðåáîâàíèÿ êîòîðîé ñóùåñòâåííî îòëè÷àþòñÿ îò ÅÔ. Áûëî ñîâåðøåííîíåÿñíî,âêàêîéìåðåîòå÷åñòâåííîåËÐÑ îòâå÷àåò òðåáîâàíèÿì ÅÔ. Êðîìå òîãî, ìåäèöèíñêîå ïðèìåíåíèå ìíîãèõ ËÐÑ â Óêðàèíå ñóùåñòâåííî îòëè÷àåòñÿ îò åâðîïåéñêîé ïðàêòèêè.

2
The State Pharmacopoeia of Ukraine. State Enterprise «Scientific and Expert Pharmacopoeial Centre». 1st ed. Kharkov: RIREH, 2001. Appendix 1. 2004. Appendix 2. Kharkov: State Enterprise «Scientific and Expert Pharmacopoeial Center»; 2008. Appendix 3. 2009. Appendix 4. 2011 (in Ukrainian).
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    ÌÅÒÐÎËÎÃÈ×ÅÑÊÎÅ ÎÁÅÑÏÅ×ÅÍÈÅ Â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ÅԖÃÔÓ, âñå ìåòîäèêè àíàëèçà, âêëþ÷àåìûå â ÃÔÓ è ñïåöèôèêàöèè ïðîèçâîäèòåëåé, äîëæíû áûòü âàëèäèðîâàíû. Îáùèå ïðèíöèïû âàëèäàöèè îïèñàíû â ñîîòâåòñòâóþùèõ äîêóìåíòàõ ICH (Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê è èñïûòàíèé — 2.2.N.2
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    è 5.3.N.2 [3]). Îäíàêî êðèòåðèè ïðèåìëåìîñòè âàëèäàöèîííûõ õàðàêòåðèñòèê íåîáõîäèìî ðàçðàáàòûâàòü ñàìîñòîÿòåëüíî. Äëÿ ýòîãî íåîáõîäèìî, ïðåæäå âñåãî, ñôîðìóëèðîâàòü òðåáîâàíèÿ ê ìàêñèìàëüíî äîïóñòèìîé íåîïðåäåëåííîñòè ìåòîäèê àíàëèçà.

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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
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    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
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    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

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    Ðàçðàáîòêà ñòàíäàðòèçîâàííûõ ïðîöåäóð âàëèäàöèè ôàðìàêîïåéíûõ ìåòîäèê ñòàíîâèòñÿ âàæíûì ýëåìåíòîì ñèñòåìû ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ êà÷åñòâà ðåçóëüòàòîâ, ïîëó÷àåìûõ ïî ýòèì ìåòîäèêàì.Òàêèåñòàíäàðòèçîâàííûåïðîöåäóðûðàçðàáîòàíû ÔÖ äëÿ âñåõ îñíîâíûõ ôàðìàêîïåéíûõ ìåòîäîâ àíàëèçà [8, 12] è âíåñåíû ñîîòâåòñòâóþùèå ðåêîìåíäàöèè â ÃÔÓ
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    . Äàííûå ñòàíäàðòèçîâàííûå ïðîöåäóðû âàëèäàöèè â íàñòîÿùåå âðåìÿ ÿâëÿþòñÿ îáùåïðèíÿòûìè íà ïðåäïðèÿòèÿõ Óêðàèíû. V. ÐÀÇÐÀÁÎÒÊÀ ÃÎÑÓÄÀÐÑÒÂÅÍÍÎÉ ÔÀÐÌÀÊÎÏÅÈ ÓÊÐÀÈÍÛ I ÈÇÄÀÍÈß ÃÔÓ I èçäàíèÿ (ÃÔÓ I) ââåäåíà â äåéñòâèå 1 îêòÿáðÿ 2001 ã.

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    ÐÀÇÐÀÁÎÒÊÀ ÃÎÑÓÄÀÐÑÒÂÅÍÍÎÉ ÔÀÐÌÀÊÎÏÅÈ ÓÊÐÀÈÍÛ I ÈÇÄÀÍÈß ÃÔÓ I èçäàíèÿ (ÃÔÓ I) ââåäåíà â äåéñòâèå 1 îêòÿáðÿ 2001 ã. Ïðèêàçîì Ìèíèñòðà çäðàâîîõðàíåíèÿ Óêðàèíû îò 12 ìàðòà 2001 ã. ¹ 95. Çà ïåðèîä 2001–2011 ãã. áûëè ðàçðàáîòàíû è ââåäåíû â äåéñòâèå òàêæå Äîïîëíåíèÿ 1 (2004 ã.), 2 (2008 ã.), 3 (2009 ã.) è 4 (2011 ã.)
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    . ÍàìîìåíòðàçðàáîòêèÃÔÓIñèòóàöèÿâÓêðàèíå õàðàêòåðèçîâàëàñü ñëåäóþùèìè îñîáåííîñòÿìè: – ïðîèçâîäñòâî, êîíòðîëü êà÷åñòâà è äèñòðèáüþöèÿ ËÑ â Óêðàèíå íå ñîîòâåòñòâîâàëè òðåáîâàíèÿì íàäëåæàùèõ ïðàêòèê (GMP, GDP, GPP).

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    Îáùèå è ÷àñòíûå ñòàòüè (ìîíîãðàôèè) ÃÔÓ ñîñòîÿò èç äâóõ ÷àñòåé, èìåþùèõ îäèíàêîâóþ ñèëó: åâðîïåéñêîé (ïåðåâîä ñîîòâåòñòâóþùåé ñòàòüè ÅÔ) è íàöèîíàëüíîé (èíäåêñ N), íå ïðîòèâîðå÷àùåé åâðîïåéñêîé, íî îòðàæàþùåé íàöèîíàëüíûåîñîáåííîñòèÓêðàèíû.Êðîìåòîãî,èìåþòñÿ è ÷èñòî íàöèîíàëüíûå ñòàòüè, íàïðèìåð, 5.3.N.1.«Ñòàòèñòè÷åñêèéàíàëèçðåçóëüòàòîâõèìè÷åñêîãî ýêñïåðèìåíòà»
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    . Äàííûé ôîðìàò ñòàòåé àíàëîãè÷åí Áðèòàíñêîé ôàðìàêîïåå è ÿâëÿåòñÿ î÷åíü ãèáêèì íà ïåðåõîäíîì ýòàïå ðàçðàáîòêè ÃÔÓ. Íàöèîíàëüíûå òðåáîâàíèÿ (â êà÷åñòâå êîòîðûõ ÷àñòî âûñòóïàëè òðåáîâàíèÿ ÃÔ ÑÑÑÐ XI [1]), ïîçâîëÿëè ñìÿã÷èòü èëè óæåñòî÷èòü òðåáîâàíèÿ ÅÔ, à òàêæå îòñðî÷èòü èõ ââåäåíèå.

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    Ïîýòîìó íà ïåðâîì ýòàïå ñòàâèëàñü çàäà÷à âåðíóòü ÝËÑ â ÃÔÓ ñ òåì, ÷òîáû çàòåì ñôîðìèðîâàòü ôàðìàêîïåéíóþ êîíöåïöèþ èõ êà÷åñòâà. Ïåðâûå îáùèå ñòàòüè íà ÝËÑ áûëè ðàçðàáîòàíû íà îñíîâå äåéñòâîâàâøèõ íà òîò ìîìåíò òðåáîâàíèé è ââåäåíû â ÃÔÓ â 2008 ã. (5.N.1)
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    . e. Îñíîâíûå äîñòèæåíèÿ ÃÔÓ I èçäàíèÿ (2001–2015 ãã.) 1) ÃÔÓ ñòàëà êðàåóãîëüíûì êàìíåì âñåé ñèñòåìû ñòàíäàðòèçàöèè ËÑ â Óêðàèíå. Âñå îñòàëüíûå äîêóìåíòû, ðåãóëèðóþùèå êà÷åñòâî ËÑ è èõ êîíòðîëü, îïèðàþòñÿ íà ÃÔÓ. 2) Ñîçäàíà äâóõóðîâíåâàÿ Íàöèîíàëüíàÿ ñèñòåìà ôàðìàöåâòè÷åñêèõ ñòàíäàðòíûõ îáðàçöî⠗ ñèñòåìà ÔÑÎ ÃÔÓ è ÐÑÎ ïðåäïðèÿòèé. 3) ÑîçäàíàýôôåêòèâíîðàáîòàþùàÿÍàöèîíàëüíàÿ ÏÏÒ êàê îáðàòíàÿ ñâÿçü

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State Pharmacopoeia of Ukraine. In 3 vols. 2nd ed. Kharkov: SE «Ukrainian scientific pharmacopoeial center of medicines quality». Volume 1. 2015. Volume 2. 2014. Volume 3. 2014 (in Ukrainian).
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    , è èõ ñòîèìîñòü äëÿ îòå÷åñòâåííûõ ïðîèçâîäèòåëåé è êîíòðîëüíûõ ëàáîðàòîðèé ïðÿìî çàâèñèò îò êóðñàíàöèîíàëüíîéâàëþòû.Ýòîñîçäàåòñèëüíóþçàâèñèìîñòüîòå÷åñòâåííîéôàðìàöåâòè÷åñêîéîòðàñëè îò âíåøíèõ ïîëèòè÷åñêèõ è ýêîíîìè÷åñêèõ ôàêòîðîâ. Ïîñòðîåíèåíåçàâèñèìîéîòå÷åñòâåííîéñèñòåìû êîíòðîëÿ êà÷åñòâà ËÑ òðåáóåò ñîçäàíèÿ Íàöèîíàëüíîé ñèñòåìû ÔÑÎ. Òàêàÿ ñèñòåìà ðàçðàáîòàíà Ôàðìàêîïåéíûì öåíòðîì Óêðàèíû (ÔÖ)
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    . Áàíê Íàöèîíàëüíîé ñèñòåìû ÔÑÎ íàñ÷èòûâàåò îêîëî 650 íàèìåíîâàíèé, ÷òî â çíà÷èòåëüíîé ñòåïåíè îáåñïå÷èâàåò ïîòðåáíîñòè îòå÷åñòâåííûõ ïîòðåáèòåëåé. Äàííûå ÔÑÎ àòòåñòóþòñÿ ÔÖ êàê ïåðâè÷íûå ñòàíäàðòíûå îáðàçöû è â ïðèìåíåíèè ýêâèâàëåíòíû ÔÑÎ ÅÔ.

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    ÌÅÒÐÎËÎÃÈ×ÅÑÊÎÅ ÎÁÅÑÏÅ×ÅÍÈÅ Â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ÅԖÃÔÓ, âñå ìåòîäèêè àíàëèçà, âêëþ÷àåìûå â ÃÔÓ è ñïåöèôèêàöèè ïðîèçâîäèòåëåé, äîëæíû áûòü âàëèäèðîâàíû. Îáùèå ïðèíöèïû âàëèäàöèè îïèñàíû â ñîîòâåòñòâóþùèõ äîêóìåíòàõ ICH (Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê è èñïûòàíèé — 2.2.N.2 [2] è 5.3.N.2
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    ). Îäíàêî êðèòåðèè ïðèåìëåìîñòè âàëèäàöèîííûõ õàðàêòåðèñòèê íåîáõîäèìî ðàçðàáàòûâàòü ñàìîñòîÿòåëüíî. Äëÿ ýòîãî íåîáõîäèìî, ïðåæäå âñåãî, ñôîðìóëèðîâàòü òðåáîâàíèÿ ê ìàêñèìàëüíî äîïóñòèìîé íåîïðåäåëåííîñòè ìåòîäèê àíàëèçà.

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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
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    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
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    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

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    Ðàçðàáîòêà ñòàíäàðòèçîâàííûõ ïðîöåäóð âàëèäàöèè ôàðìàêîïåéíûõ ìåòîäèê ñòàíîâèòñÿ âàæíûì ýëåìåíòîì ñèñòåìû ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ êà÷åñòâà ðåçóëüòàòîâ, ïîëó÷àåìûõ ïî ýòèì ìåòîäèêàì.Òàêèåñòàíäàðòèçîâàííûåïðîöåäóðûðàçðàáîòàíû ÔÖ äëÿ âñåõ îñíîâíûõ ôàðìàêîïåéíûõ ìåòîäîâ àíàëèçà [8, 12] è âíåñåíû ñîîòâåòñòâóþùèå ðåêîìåíäàöèè â ÃÔÓ
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    . Äàííûå ñòàíäàðòèçîâàííûå ïðîöåäóðû âàëèäàöèè â íàñòîÿùåå âðåìÿ ÿâëÿþòñÿ îáùåïðèíÿòûìè íà ïðåäïðèÿòèÿõ Óêðàèíû. V. ÐÀÇÐÀÁÎÒÊÀ ÃÎÑÓÄÀÐÑÒÂÅÍÍÎÉ ÔÀÐÌÀÊÎÏÅÈ ÓÊÐÀÈÍÛ I ÈÇÄÀÍÈß ÃÔÓ I èçäàíèÿ (ÃÔÓ I) ââåäåíà â äåéñòâèå 1 îêòÿáðÿ 2001 ã.

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    Îáùèå è ÷àñòíûå ñòàòüè (ìîíîãðàôèè) ÃÔÓ ñîñòîÿò èç äâóõ ÷àñòåé, èìåþùèõ îäèíàêîâóþ ñèëó: åâðîïåéñêîé (ïåðåâîä ñîîòâåòñòâóþùåé ñòàòüè ÅÔ) è íàöèîíàëüíîé (èíäåêñ N), íå ïðîòèâîðå÷àùåé åâðîïåéñêîé, íî îòðàæàþùåé íàöèîíàëüíûåîñîáåííîñòèÓêðàèíû.Êðîìåòîãî,èìåþòñÿ è ÷èñòî íàöèîíàëüíûå ñòàòüè, íàïðèìåð, 5.3.N.1.«Ñòàòèñòè÷åñêèéàíàëèçðåçóëüòàòîâõèìè÷åñêîãî ýêñïåðèìåíòà»
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    . Äàííûé ôîðìàò ñòàòåé àíàëîãè÷åí Áðèòàíñêîé ôàðìàêîïåå è ÿâëÿåòñÿ î÷åíü ãèáêèì íà ïåðåõîäíîì ýòàïå ðàçðàáîòêè ÃÔÓ. Íàöèîíàëüíûå òðåáîâàíèÿ (â êà÷åñòâå êîòîðûõ ÷àñòî âûñòóïàëè òðåáîâàíèÿ ÃÔ ÑÑÑÐ XI [1]), ïîçâîëÿëè ñìÿã÷èòü èëè óæåñòî÷èòü òðåáîâàíèÿ ÅÔ, à òàêæå îòñðî÷èòü èõ ââåäåíèå.

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    Äàííàÿ ñèòóàöèÿ ñ ËÐÑ ñîõðàíèòñÿ â îáîçðèìîì áóäóùåì è òðåáóåò áîëüøèõ ýêñïåðèìåíòàëüíûõ èññëåäîâàíèé[7].Çíà÷èòåëüíûåïðîáëåìûâîçíèêàþòè ñ âàëèäàöèåé ìåòîäèê êîíòðîëÿ êà÷åñòâà ËÐÑ [15]. Ôàðìàêîïåéíûì öåíòðîì áûëè ïðîâåäåíû îáøèðíûå ñèñòåìíûå èññëåäîâàíèÿ [16], ÷òî ïîçâîëèëî ââîäèòü â ÃÔÓ, íà÷èíàÿ ñ 2008 ã.
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    , ìîíîãðàôèè íà ËÐÑ. c. Ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà  ÅÔ îòñóòñòâóþò ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà (ÃËÑ), ïîýòîìó â ÃÔÓ îíè ìîãóò áûòü òîëüêî íàöèîíàëüíûìè. Ïîñêîëüêó èñïîëüçîâàòü äëÿ ðàçðàáîòêè ìîíîãðàôèé íà ÃËÑ ìàòåðèàëû äðóãèõ ôàðìàêîïåé (ïðåæäå âñåãî, Àìåðèêàíñêîé (USP) è Áðèòàíñêîé (BP)) íå ïîçâîëÿåò àâòîðñêîå ïðàâî, ïåðâîíà÷àëüíî áûëè ðàçðàáîòàíû íåñêîëüêî ìîí

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     íàñòîÿùåå âðåìÿ ïåðåä ÔÖ ñòîèò ïðîáëåìà ðàçðàáîòêè êîíöåïöèè ââåäåíèÿ òðåáîâàíèé íà âåòåðèíàðíûå ËÑ â ÃÔÓ, ò.å. ïðîáëåìà ñîîòíîøåíèÿ åâðîïåéñêîé è íàöèîíàëüíîé ÷àñòåé ñòàòåé. Ýòà ðàáîòà òðåáóåò áîëåå àêòèâíîãî ñîòðóäíè÷åñòâà ñ ñîîòâåòñòâóþùèìè îòå÷åñòâåííûìè óïîëíîìî÷åííûìè îðãàíàìè. Òàáëèöà 1 ÑÎÎÒÍÎØÅÍÈÅ ÒÅÊÑÒΠÅÔ È ÃÔÓ II Íàèìåíîâàíèå ðàçäåëà ÅÔ 8.2 ÃÔÓ II
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    [3]
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    % îõâàòà Îáùèå ñòàòüè è òåêñòû2969 295199.4 Âàêöèíû1435739.9 Èììóíîñûâîðîòêè1212100.0 Ðàäèîôàðìàöåâòè÷åñêèå ïðåïàðàòû 7011.4 Øîâíûé ìàòåðèàë1212100.0 Ëåêàðñòâåííîå ðàñòèòåëüíîå ñûðüå 27317062.3 Ãîìåîïàòèÿ28621.4 Ñóáñòàíöèè167437222.2 Ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà —135— Ýêñòåìïîðàëüíûå ëåêàðñòâåííûå ñðåäñòâà —6 — Äèåòè÷åñêèå äîáàâêè—1— á) Äèåòè÷åñêèå äîáàâêè.

4
Gryzodub AI, Levin MG, Leontiev DA, et al. Certification of standard samples. Certification of secondary reference materials for the quantitative chromatographic analysis of drugs. Farmakom 1999; (2): 46–51 (in Russian).
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    , è èõ ñòîèìîñòü äëÿ îòå÷åñòâåííûõ ïðîèçâîäèòåëåé è êîíòðîëüíûõ ëàáîðàòîðèé ïðÿìî çàâèñèò îò êóðñàíàöèîíàëüíîéâàëþòû.Ýòîñîçäàåòñèëüíóþçàâèñèìîñòüîòå÷åñòâåííîéôàðìàöåâòè÷åñêîéîòðàñëè îò âíåøíèõ ïîëèòè÷åñêèõ è ýêîíîìè÷åñêèõ ôàêòîðîâ. Ïîñòðîåíèåíåçàâèñèìîéîòå÷åñòâåííîéñèñòåìû êîíòðîëÿ êà÷åñòâà ËÑ òðåáóåò ñîçäàíèÿ Íàöèîíàëüíîé ñèñòåìû ÔÑÎ. Òàêàÿ ñèñòåìà ðàçðàáîòàíà Ôàðìàêîïåéíûì öåíòðîì Óêðàèíû (ÔÖ)
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    . Áàíê Íàöèîíàëüíîé ñèñòåìû ÔÑÎ íàñ÷èòûâàåò îêîëî 650 íàèìåíîâàíèé, ÷òî â çíà÷èòåëüíîé ñòåïåíè îáåñïå÷èâàåò ïîòðåáíîñòè îòå÷åñòâåííûõ ïîòðåáèòåëåé. Äàííûå ÔÑÎ àòòåñòóþòñÿ ÔÖ êàê ïåðâè÷íûå ñòàíäàðòíûå îáðàçöû è â ïðèìåíåíèè ýêâèâàëåíòíû ÔÑÎ ÅÔ.

5
Gryzodub AI, Leontiev DA, Levin MG. Metrological aspects of formal methods of quality control of medicines. 1. HPLC Methodology. Fiziologichno aktivni rechoviny;1(31): 32–44 (in Russian).
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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
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    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
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    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

6
Gryzodub AI, Arhipova NN, Kozhushko GI, et al. Certification of industrial pellets as test samples for professional testing laboratories for quality control of drugs: managing the heterogeneity. Farmakom 2003; (3): 5–19 (in Russian).
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    ÏÐÎÃÐÀÌÌÛ ÏÐÎÔÅÑÑÈÎÍÀËÜÍÎÃÎ ÒÅÑÒÈÐÎÂÀÍÈß (ÏÏÒ) ËÀÁÎÐÀÒÎÐÈÉ ÊÎÍÒÐÎËß ÊÀ×ÅÑÒÂÀ ËÑ Ó÷àñòèå âî âíåøíåì òåñòèðîâàíèè ÿâëÿåòñÿ îáÿçàòåëüíûì óñëîâèåì äëÿ àòòåñòàöèè êîíòðîëüíûõ ëàáîðàòîðèé, ïîýòîìó ÏÏÒ øèðîêî ðàñïðîñòðàíåíû â ìèðå. Ðàçðàáîòàíà òàêàÿ ÏÏÒ è ÔÖ
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    . Îäíàêî, íàðÿäó ñ îáû÷íûìè öåëÿìè ÏÏÒ, äàííàÿ ïðîãðàììà ñòàâèò è äðóãóþ, ãîðàçäî áîëåå âàæíóþ äëÿ ðàçâèòèÿ ÃÔÓ çàäà÷ó. ÏÏÒ ðàçðàáîòàíà ÔÖ òàêèì îáðàçîì, ÷òî îíà ïðîâîäèòñÿ íà ïðîìûøëåííûõ ñåðèÿõËÑ(àòòåñòîâàííûõíåîáõîäèìûìîáðàçîì)ñèñïîëüçîâàíèåì ôàðìàêîïåéíûõ ìåòîäèê, ò.å. îíà ÿâëÿåòñÿ îáðàòíîé ñâÿçüþ ÃÔÓ ñ ïîëüçîâàòåëÿìè [6, 18].

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    ÏÏÒ ðàçðàáîòàíà ÔÖ òàêèì îáðàçîì, ÷òî îíà ïðîâîäèòñÿ íà ïðîìûøëåííûõ ñåðèÿõËÑ(àòòåñòîâàííûõíåîáõîäèìûìîáðàçîì)ñèñïîëüçîâàíèåì ôàðìàêîïåéíûõ ìåòîäèê, ò.å. îíà ÿâëÿåòñÿ îáðàòíîé ñâÿçüþ ÃÔÓ ñ ïîëüçîâàòåëÿìè
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    . Ïî ðåçóëüòàòàì ðàóíäîâ ÏÏÒ âûÿâëÿþòñÿ ïðîáëåìû, íàìå÷àþòñÿ ïóòè èõ ðåøåíèÿ è ââîäÿòñÿ, ïðèíåîáõîäèìîñòè,íåîáõîäèìûåêîððåêòèâûâôàðìàêîïåéíûå ìåòîäû è ìåòîäèêè àíàëèçà, îïèñàííûå â îáùèõ è ÷àñòíûõ ñòàòüÿõ.

7
Gryzodub AI, Georgievsky GV, Tihonenko TM, Georgievsky VP. Problems of introduction of monographs on herbal drugs in the State Pharmacopoeia of Ukraine. Farmakom 2004; (4): 3–17 (in Russian).
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    Íàïðèìåð, øèïîâíèêâÅԗýòîèñòî÷íèêàñêîðáèíîâîéêèñëîòû, àâÓêðàèíåøèïîâíèê—ýòîèñòî÷íèêïîëó÷åíèÿêàðîòèíîèäîâ («Êàðîòîëèí»), ìàñëà øèïîâíèêà è ïîëèôåíîëîâ («Õîëîñàñ»). Äàííàÿ ñèòóàöèÿ ñ ËÐÑ ñîõðàíèòñÿ â îáîçðèìîì áóäóùåì è òðåáóåò áîëüøèõ ýêñïåðèìåíòàëüíûõ èññëåäîâàíèé
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    .Çíà÷èòåëüíûåïðîáëåìûâîçíèêàþòè ñ âàëèäàöèåé ìåòîäèê êîíòðîëÿ êà÷åñòâà ËÐÑ [15]. Ôàðìàêîïåéíûì öåíòðîì áûëè ïðîâåäåíû îáøèðíûå ñèñòåìíûå èññëåäîâàíèÿ [16], ÷òî ïîçâîëèëî ââîäèòü â ÃÔÓ, íà÷èíàÿ ñ 2008 ã. [3], ìîíîãðàôèè íà ËÐÑ. c.

8
Gryzodub AI. Standard procedures for the validation of methods of quality control of medicines. Farmakom 2006; (1–2): 35–44 (in Russian).
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    Ðàçðàáîòêà ñòàíäàðòèçîâàííûõ ïðîöåäóð âàëèäàöèè ôàðìàêîïåéíûõ ìåòîäèê ñòàíîâèòñÿ âàæíûì ýëåìåíòîì ñèñòåìû ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ êà÷åñòâà ðåçóëüòàòîâ, ïîëó÷àåìûõ ïî ýòèì ìåòîäèêàì.Òàêèåñòàíäàðòèçîâàííûåïðîöåäóðûðàçðàáîòàíû ÔÖ äëÿ âñåõ îñíîâíûõ ôàðìàêîïåéíûõ ìåòîäîâ àíàëèçà
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    è âíåñåíû ñîîòâåòñòâóþùèå ðåêîìåíäàöèè â ÃÔÓ [2, 3]. Äàííûå ñòàíäàðòèçîâàííûå ïðîöåäóðû âàëèäàöèè â íàñòîÿùåå âðåìÿ ÿâëÿþòñÿ îáùåïðèíÿòûìè íà ïðåäïðèÿòèÿõ Óêðàèíû. V. ÐÀÇÐÀÁÎÒÊÀ ÃÎÑÓÄÀÐÑÒÂÅÍÍÎÉ ÔÀÐÌÀÊÎÏÅÈ ÓÊÐÀÈÍÛ I ÈÇÄÀÍÈß ÃÔÓ I èçäàíèÿ (ÃÔÓ I) ââåäåíà â äåéñòâèå 1 îêòÿáðÿ 2001 ã.

9
Gryzodub AI, Tovmasyan EK. Problems of standardization of homeopathic finished drugs. Farmakom 2007; (1): 13–18 (in Russian).
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    Äëÿ íèõ íåâîçìîæíî êîíòðîëèðîâàòü ïðèìåñè, ïðîäóêòû ðàñïàäà, ñòåïåíü ðàñòâîðåíèÿ, îäíîðîäíîñòü ñîäåðæàíèÿ, ñðîê ãîäíîñòè è ò.ä., ò.å. âñå òî, ÷òî ÿâëÿåòñÿ åñòåñòâåííûì äëÿ àëëîïàòè÷åñêèõ ËÑ. Ñïåöèôèêàöèè íà ÃÃÏ íå ïîçâîëÿþò, êàê ïðàâèëî, îòëè÷èòü ïðåïàðàò íàäëåæàùåãî êà÷åñòâà îò íåêà÷åñòâåííîãî. Ïîýòîìó ðàçðàáîòêà ìîíîãðàôèé íà ÃÃÏ íåâîçìîæíà
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    [9]
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    . Óïîð íàäî äåëàòü íà òåõíîëîãèþ, íàäëåæàùèå ïðàêòèêè è ñèñòåìû êà÷åñòâà. d. Ýêñòåìïîðàëüíûå ëåêàðñòâåííûå ñðåäñòâà Ïîñëå íà÷àëà ìàññîâîãî ïðîèçâîäñòâà â Óêðàèíå ïðåïàðàòîâ-äæåíåðèêîâ ðîëü è íåîáõîäèìîñòü ïðåïàðàòîâ, èçãîòàâëèâàåìûõ â àïòåêàõ (ýêñòåìïîðàëüíûõ ËÑ — ÝËÑ), ðåçêî ñíèçèëàñü.

10
Leontiev DA, Gryzodub AI. Metrological control of the quality of the measurement results. Farmakom; (2): 16–25 (in Russian).
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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

11
Gryzodub AI. Application of spectrophotometry in the quality control of medicines. In: Analytical chemistry in the creation, standardization and quality control of medicines. V. 1. Kharkiv: NTMT; 2011. P. 96–202 (in Russian).
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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

12
Gryzodub O. Standardized validation schemes for drug quality control procedures. Kharkov: State enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines»; 2016 (in Russian).
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    Ðàçðàáîòêà ñòàíäàðòèçîâàííûõ ïðîöåäóð âàëèäàöèè ôàðìàêîïåéíûõ ìåòîäèê ñòàíîâèòñÿ âàæíûì ýëåìåíòîì ñèñòåìû ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ êà÷åñòâà ðåçóëüòàòîâ, ïîëó÷àåìûõ ïî ýòèì ìåòîäèêàì.Òàêèåñòàíäàðòèçîâàííûåïðîöåäóðûðàçðàáîòàíû ÔÖ äëÿ âñåõ îñíîâíûõ ôàðìàêîïåéíûõ ìåòîäîâ àíàëèçà
    Exact
    [8, 12]
    Suffix
    è âíåñåíû ñîîòâåòñòâóþùèå ðåêîìåíäàöèè â ÃÔÓ [2, 3]. Äàííûå ñòàíäàðòèçîâàííûå ïðîöåäóðû âàëèäàöèè â íàñòîÿùåå âðåìÿ ÿâëÿþòñÿ îáùåïðèíÿòûìè íà ïðåäïðèÿòèÿõ Óêðàèíû. V. ÐÀÇÐÀÁÎÒÊÀ ÃÎÑÓÄÀÐÑÒÂÅÍÍÎÉ ÔÀÐÌÀÊÎÏÅÈ ÓÊÐÀÈÍÛ I ÈÇÄÀÍÈß ÃÔÓ I èçäàíèÿ (ÃÔÓ I) ââåäåíà â äåéñòâèå 1 îêòÿáðÿ 2001 ã.

13
Leontiev DA. Pharmaceutical standard samples. In: Analytical chemistry in the creation, standardization and quality control of medicines. V. 3. Kharkiv: NTMT; 2011. P. 1064–1117 (in Russian).
Total in-text references: 1
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    Ìèðîâàÿ ïðàêòèêà — èñïîëüçîâàíèå äëÿ ýòîãî ðàáî÷èõ ñòàíäàðòíûõ îáðàçöîâ (ÐÑÎ), àòòåñòîâàííûõïðåäïðèÿòèÿìèïîÔÑÎêàêâòîðè÷íûåñòàíäàðòíûå îáðàçöû. Ýòî îáåñïå÷èâàåò ïðîñëåæèâàåìîñòü è ñòàíäàðòèçàöèþ êîíòðîëÿ êà÷åñòâà ËÑ. ÔÖ ðàçðàáîòàë íåîáõîäèìûå ïîëîæåíèÿ îá ÐÑÎ è âíåäðèëèõíàâñåõêðóïíûõïðåäïðèÿòèÿõÓêðàèíû
    Exact
    [13]
    Suffix
    . Ñèñòåìû ÔÑÎ è ÐÑÎ ôîðìèðóþò â Óêðàèíå Íàöèîíàëüíóþ ñèñòåìó ôàðìàöåâòè÷åñêèõ ñòàíäàðòíûõ îáðàçöîâ. III. ÏÐÎÃÐÀÌÌÛ ÏÐÎÔÅÑÑÈÎÍÀËÜÍÎÃÎ ÒÅÑÒÈÐÎÂÀÍÈß (ÏÏÒ) ËÀÁÎÐÀÒÎÐÈÉ ÊÎÍÒÐÎËß ÊÀ×ÅÑÒÂÀ ËÑ Ó÷àñòèå âî âíåøíåì òåñòèðîâàíèè ÿâëÿåòñÿ îáÿçàòåëüíûì óñëîâèåì äëÿ àòòåñòàöèè êîíòðîëüíûõ ëàáîðàòîðèé, ïîýòîìó ÏÏÒ øèðîêî ðàñïðîñòðàíåíû â ìèðå.

14
Sur SV, Zvolinskaya NN. Vocational testing as a means of standardization of laboratories quality control of medicines. In: Analytical chemistry in the creation, standardization and quality control of medicines. V. 3. Kharkiv: NTMT; 2011. P. 1178–1219 (in Russian).
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    ÏÐÎÃÐÀÌÌÛ ÏÐÎÔÅÑÑÈÎÍÀËÜÍÎÃÎ ÒÅÑÒÈÐÎÂÀÍÈß (ÏÏÒ) ËÀÁÎÐÀÒÎÐÈÉ ÊÎÍÒÐÎËß ÊÀ×ÅÑÒÂÀ ËÑ Ó÷àñòèå âî âíåøíåì òåñòèðîâàíèè ÿâëÿåòñÿ îáÿçàòåëüíûì óñëîâèåì äëÿ àòòåñòàöèè êîíòðîëüíûõ ëàáîðàòîðèé, ïîýòîìó ÏÏÒ øèðîêî ðàñïðîñòðàíåíû â ìèðå. Ðàçðàáîòàíà òàêàÿ ÏÏÒ è ÔÖ
    Exact
    [6, 14, 18]
    Suffix
    . Îäíàêî, íàðÿäó ñ îáû÷íûìè öåëÿìè ÏÏÒ, äàííàÿ ïðîãðàììà ñòàâèò è äðóãóþ, ãîðàçäî áîëåå âàæíóþ äëÿ ðàçâèòèÿ ÃÔÓ çàäà÷ó. ÏÏÒ ðàçðàáîòàíà ÔÖ òàêèì îáðàçîì, ÷òî îíà ïðîâîäèòñÿ íà ïðîìûøëåííûõ ñåðèÿõËÑ(àòòåñòîâàííûõíåîáõîäèìûìîáðàçîì)ñèñïîëüçîâàíèåì ôàðìàêîïåéíûõ ìåòîäèê, ò.å. îíà ÿâëÿåòñÿ îáðàòíîé ñâÿçüþ ÃÔÓ ñ ïîëüçîâàòåëÿìè [6, 18].

15
Gryzodub AI, Evtifeeva OA, Proskurina KI. Features of pharmacopoeia approaches to quantification of medicinal plants and summary herbal remedies. Farmakom 2012; (3): 7–30 (in Russian).
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    Íàïðèìåð, øèïîâíèêâÅԗýòîèñòî÷íèêàñêîðáèíîâîéêèñëîòû, àâÓêðàèíåøèïîâíèê—ýòîèñòî÷íèêïîëó÷åíèÿêàðîòèíîèäîâ («Êàðîòîëèí»), ìàñëà øèïîâíèêà è ïîëèôåíîëîâ («Õîëîñàñ»). Äàííàÿ ñèòóàöèÿ ñ ËÐÑ ñîõðàíèòñÿ â îáîçðèìîì áóäóùåì è òðåáóåò áîëüøèõ ýêñïåðèìåíòàëüíûõ èññëåäîâàíèé[7].Çíà÷èòåëüíûåïðîáëåìûâîçíèêàþòè ñ âàëèäàöèåé ìåòîäèê êîíòðîëÿ êà÷åñòâà ËÐÑ
    Exact
    [15]
    Suffix
    . Ôàðìàêîïåéíûì öåíòðîì áûëè ïðîâåäåíû îáøèðíûå ñèñòåìíûå èññëåäîâàíèÿ [16], ÷òî ïîçâîëèëî ââîäèòü â ÃÔÓ, íà÷èíàÿ ñ 2008 ã. [3], ìîíîãðàôèè íà ËÐÑ. c. Ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà  ÅÔ îòñóòñòâóþò ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà (ÃËÑ), ïîýòîìó â ÃÔÓ îíè ìîãóò áûòü òîëüêî íàöèîíàëüíûìè.

16
Kotov AG. Pharmacopoeial aspects of standardization of medicinal plants and drugs based on it. Dr. Pharm. Sci [dissertation]. Kharkiv; 2013 (in Ukrainian).
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    Äàííàÿ ñèòóàöèÿ ñ ËÐÑ ñîõðàíèòñÿ â îáîçðèìîì áóäóùåì è òðåáóåò áîëüøèõ ýêñïåðèìåíòàëüíûõ èññëåäîâàíèé[7].Çíà÷èòåëüíûåïðîáëåìûâîçíèêàþòè ñ âàëèäàöèåé ìåòîäèê êîíòðîëÿ êà÷åñòâà ËÐÑ [15]. Ôàðìàêîïåéíûì öåíòðîì áûëè ïðîâåäåíû îáøèðíûå ñèñòåìíûå èññëåäîâàíèÿ
    Exact
    [16]
    Suffix
    , ÷òî ïîçâîëèëî ââîäèòü â ÃÔÓ, íà÷èíàÿ ñ 2008 ã. [3], ìîíîãðàôèè íà ËÐÑ. c. Ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà  ÅÔ îòñóòñòâóþò ìîíîãðàôèè íà ãîòîâûå ëåêàðñòâåííûå ñðåäñòâà (ÃËÑ), ïîýòîìó â ÃÔÓ îíè ìîãóò áûòü òîëüêî íàöèîíàëüíûìè.

17
Leontiev DA, Gryzodub AI. Metrological control of analytical results. The specificity of the concept of uncertainty of pharmaceutical analysis. Razrabotka i registratsiya lekarstvennyh sredstv 2013;4(5): 68–75 (in Russian).
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    ñôîðìóëèðîâàòü òðåáîâàíèÿ ê èñïîëüçóåìîìó îáîðóäîâàíèþ, ìåðíîé ïîñóäå è ïåðñîíàëó (÷òîáû îíè áûëè â ñîñòîÿíèè îáåñïå÷èòü íåîáõîäèìûå âàëèäàöèîííûå õàðàêòåðèñòèêè), à òàêæå ðàçðàáîòàòü ïðîöåäóðó èõ êâàëèôèêàöèè. ÀòòåñòàöèÿÔÑÎèïðîâåäåíèåÏÏÒòàêæåòðåáîâàëè ñîçäàíèÿ íåîáõîäèìîãî ìåòðîëîãè÷åñêîãî îáåñïå÷åíèÿ. Òàêàÿ ìåòðîëîãè÷åñêàÿ áàçà áûëà ðàçðàáîòàíà ÔÖ, îñíîâíûå ðåêîìåíäàöèè âíåñåíû â ÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    è â íàñòîÿùåå âðåìÿ ÿâëÿåòñÿ îäíèì èç îñíîâíûõ íàó÷íûõ íàïðàâëåíèé ÔÖ. Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê.

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    Âàëèäàöèÿ àíàëèòè÷åñêèõ ìåòîäèê.Êàê óæå óïîìèíàëîñü, â äîêóìåíòàõ ICH óêàçàíû òîëüêî îáùèå ïðèíöèïû âàëèäàöèè àíàëèòè÷åñêèõ ìåòîäèê. Êðèòåðèàëüíàÿ áàçà âàëèäàöèè áûëà ðàçðàáîòàíà ÔÖ â ðàìêàõñîçäàíèÿìåòðîëîãè÷åñêîãîîáåñïå÷åíèÿÃÔÓ
    Exact
    [2, 3, 5, 10, 11, 17]
    Suffix
    .Îäíàêîââåäåíèåâàëèäèðîâàííûõ ìåòîäèê â ÃÔÓ è ñïåöèôèêàöèè òðåáîâàëî ñòàíäàðòèçàöèè ïðîöåäóðû âàëèäàöèè ýòèõ ìåòîäèê.  ïðîòèâíîì ñëó÷àå ìîãëè ïîëó÷àòüñÿ ðàçíûå âûâîäû ïî ðåçóëüòàòàì âàëèäàöèè ïðè èñïîëüçîâàíèè ðàçíûõ ïðîöåäóð åå ïðîâåäåíèÿ.

18
Dmitrieva MV, Lukianova IS, Leontiev DA, Gryzodub AI. Identification of active substance by absorption spectrophotometry in the infrared region in the 10th round of the Programme of professional testing laboratories: certification of test samples, evaluation criteria, analysis of the results. Farmakom 2014; (4): 5–12 (in Russian).
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    ÏÐÎÃÐÀÌÌÛ ÏÐÎÔÅÑÑÈÎÍÀËÜÍÎÃÎ ÒÅÑÒÈÐÎÂÀÍÈß (ÏÏÒ) ËÀÁÎÐÀÒÎÐÈÉ ÊÎÍÒÐÎËß ÊÀ×ÅÑÒÂÀ ËÑ Ó÷àñòèå âî âíåøíåì òåñòèðîâàíèè ÿâëÿåòñÿ îáÿçàòåëüíûì óñëîâèåì äëÿ àòòåñòàöèè êîíòðîëüíûõ ëàáîðàòîðèé, ïîýòîìó ÏÏÒ øèðîêî ðàñïðîñòðàíåíû â ìèðå. Ðàçðàáîòàíà òàêàÿ ÏÏÒ è ÔÖ
    Exact
    [6, 14, 18]
    Suffix
    . Îäíàêî, íàðÿäó ñ îáû÷íûìè öåëÿìè ÏÏÒ, äàííàÿ ïðîãðàììà ñòàâèò è äðóãóþ, ãîðàçäî áîëåå âàæíóþ äëÿ ðàçâèòèÿ ÃÔÓ çàäà÷ó. ÏÏÒ ðàçðàáîòàíà ÔÖ òàêèì îáðàçîì, ÷òî îíà ïðîâîäèòñÿ íà ïðîìûøëåííûõ ñåðèÿõËÑ(àòòåñòîâàííûõíåîáõîäèìûìîáðàçîì)ñèñïîëüçîâàíèåì ôàðìàêîïåéíûõ ìåòîäèê, ò.å. îíà ÿâëÿåòñÿ îáðàòíîé ñâÿçüþ ÃÔÓ ñ ïîëüçîâàòåëÿìè [6, 18].

  2. In-text reference with the coordinate start=7163
    Prefix
    ÏÏÒ ðàçðàáîòàíà ÔÖ òàêèì îáðàçîì, ÷òî îíà ïðîâîäèòñÿ íà ïðîìûøëåííûõ ñåðèÿõËÑ(àòòåñòîâàííûõíåîáõîäèìûìîáðàçîì)ñèñïîëüçîâàíèåì ôàðìàêîïåéíûõ ìåòîäèê, ò.å. îíà ÿâëÿåòñÿ îáðàòíîé ñâÿçüþ ÃÔÓ ñ ïîëüçîâàòåëÿìè
    Exact
    [6, 18]
    Suffix
    . Ïî ðåçóëüòàòàì ðàóíäîâ ÏÏÒ âûÿâëÿþòñÿ ïðîáëåìû, íàìå÷àþòñÿ ïóòè èõ ðåøåíèÿ è ââîäÿòñÿ, ïðèíåîáõîäèìîñòè,íåîáõîäèìûåêîððåêòèâûâôàðìàêîïåéíûå ìåòîäû è ìåòîäèêè àíàëèçà, îïèñàííûå â îáùèõ è ÷àñòíûõ ñòàòüÿõ.