The 12 references with contexts in paper A. Kozlovich V., V. Kotikov N., L. Korsun V., S. Kalinichev A., А. Козлович В., В. Котиков Н., Л. Корсун В., С. Калиничев А. (2018) “Анализ международного опыта по созданию информационно-аналитических баз стандартных образцов // Analysis of international experience in creating reference standards databases” / spz:neicon:vedomostincesmp:y:2017:i:4:p:242-250

1
Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ 6Rdb43 (in Russian).
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    êîíòðîëü êà÷åñòâà èññëåäóåìûõ ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) ñ ïîìîùüþ ôèçèêî-õèìè÷åñêèõ è áèîëîãè÷åñêèõ ìåòîäîâ â öåëÿõ ïîäòâåðæäåíèÿ ñîîòâåòñòâèÿ ËÑ òðåáîâàíèÿì íîðìàòèâíîé äîêóìåíòàöèè, óñòàíîâëåííûì ïðè îñóùåñòâëåíèè ãîñóäàðñòâåííîé ðåãèñòðàöèè, è êîòîðûå ïðèìåíÿþòñÿ äëÿ êàëèáðîâêè ñòàíäàðòíûõ îáðàçöîâ ïðîèçâîäèòåëÿ ËÑ, èñïîëüçóåìûõ äëÿ êîíòðîëÿ êà÷åñòâà è èíûõ öåëåé ïðè îáðàùåíèè ËÑ
    Exact
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    . ÑÎ èìåþò ïåðâîñòåïåííîå çíà÷åíèå â ñèñòåìå îáåñïå÷åíèÿ åäèíñòâà èçìåðåíèé. Ïðè îòñóòñòâèè ñîîòâåòñòâóþùèõ ýòàëîíîâ â íàöèîíàëüíûõ ìåòðîëîãè÷åñêèõ èíñòèòóòàõ ÑÎ ÿâëÿþòñÿ åäèíñòâåííûì ñðåäñòâîì äëÿ äîñòèæåíèÿ íåîáõîäèìîé òî÷íîñòè èçìåðåíèé, è ïîçâîëÿþò îöåíèâàòü ñîïîñòàâèìîñòü ïîëó÷åííûõ ðåçóëüòàòîâ [2].

2
State Standard R 8.694-2010. State system for ensuring the uniformity of measurements. Standard samples of materials (substances). General statistical principles for determining metrological characteristics. Moscow: Standartinform; 2012 (in Russian).
Total in-text references: 1
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    Ïðè îòñóòñòâèè ñîîòâåòñòâóþùèõ ýòàëîíîâ â íàöèîíàëüíûõ ìåòðîëîãè÷åñêèõ èíñòèòóòàõ ÑÎ ÿâëÿþòñÿ åäèíñòâåííûì ñðåäñòâîì äëÿ äîñòèæåíèÿ íåîáõîäèìîé òî÷íîñòè èçìåðåíèé, è ïîçâîëÿþò îöåíèâàòü ñîïîñòàâèìîñòü ïîëó÷åííûõ ðåçóëüòàòîâ
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    . Ãîñóäàðñòâåííàÿ ôàðìàêîïåÿ Ðîññèéñêîé Ôåäåðàöèè XIII èçäàíèÿ (ÃÔ XIII) â êà÷åñòâå ôàðìàêîïåéíûõ ñòàíäàðòíûõ îáðàçöîâ ïðåäóñìàòðèâàåò èñïîëüçîâàíèå â òîì ÷èñëå ÑÎ çàðóáåæíûõ ôàðìàêîïåé, íàïðèìåð, ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ [3].

3
State Pharmacopoeia of the Russian Federation. XIII ed. V. 1. Moscow; 2015. Available from: http://193.232.7.120/feml/clinical_ref/ pharmacopoeia_1/HTML/#55/z (in Russian).
Total in-text references: 2
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    Ãîñóäàðñòâåííàÿ ôàðìàêîïåÿ Ðîññèéñêîé Ôåäåðàöèè XIII èçäàíèÿ (ÃÔ XIII) â êà÷åñòâå ôàðìàêîïåéíûõ ñòàíäàðòíûõ îáðàçöîâ ïðåäóñìàòðèâàåò èñïîëüçîâàíèå â òîì ÷èñëå ÑÎ çàðóáåæíûõ ôàðìàêîïåé, íàïðèìåð, ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ
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    . Öåëü ðàáîòû— èçó÷åíèå ìåæäóíàðîäíîãî îïûòà ïî ñîçäàíèþ èíôîðìàöèîííî-àíàëèòè÷åñêèõ áàç ñòàíäàðòíûõ îáðàçöîâ. Ñîâðåìåííûé óðîâåíü èíôîðìàòèçàöèè æèçíåííîãî öèêëà ËÑ ïîäðàçóìåâàåò äîñòóï çàèíòåðåñîâàííûõ ëèö ê àêòóàëüíûì íîðìàòèâíûì è ñïðàâî÷íûì äàííûì â îíëàéí-ðåæèìå.

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    ãîñóäàðñòâåííîå áþäæåòíîå ó÷ðåæäåíèå «Íàó÷íûé öåíòð ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ »Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè (ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè) ïðèíèìàåò àêòèâíîå ó÷àñòèå â ïîäãîòîâêå Ãîñóäàðñòâåííîé ôàðìàêîïåè Ðîññèéñêîé Ôåäåðàöèè, îñóùåñòâëÿÿ èíèöèàòèâíóþ äåÿòåëüíîñòü ïî ðàçðàáîòêå è âíåäðåíèþ íîâûõ îáùèõ ôàðìàêîïåéíûõ ñòàòåé è ôàðìàêîïåéíûõ ñòàòåé
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    . Ñôåðà óñòàâíîé äåÿòåëüíîñòè ó÷ðåæäåíèÿ ïðåäîñòàâëÿåò ðåàëüíóþ âîçìîæíîñòü ðàçðàáîòêè, àòòåñòàöèè è ïðèìåíåíèÿ ÑÎ ËÑ.  íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ).

4
The National Institute for Biological Standards and Control. Biological reference materials. Available from: https:// goo.gl/AYTHzY.
Total in-text references: 3
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    íà îôèöèàëüíûõ ñàéòàõ EDQM (European Directorate for the Quality of Medicines, Åâðîïåéñêèé äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ)
    Exact
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    . Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ [5], â USP — áîëåå 3500 [6]. ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

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     íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ). ÊîìÐèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC
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    Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC [4] ìåð÷åñêàÿ ÷àñòü ïðîåêòà (ðèñ. 9) äîñòóïíà âñåì çàèíòåðåñîâàííûì ëèöàì íà ñòðàíèöå îôèöèàëüíîãî ñàéòà îðãàíèçàöèè [11]. Ìåæäó òåì, ñóùåñòâóþùèå ðàçëè÷íîãî ðîäà ðååñòðû ÑÎ íå âñåãäà îáåñïå÷èâàþò ïîäðîáíîé èíôîðìàöèåé îá èõ ôèçèêî-õèìè÷åñêèõ ñâîéñòâàõ è ìåòðîëîãè÷åñêèõ õàðàêòåðèñòèêàõ.

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     íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ). ÊîìÐèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC [4] Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC
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    ìåð÷åñêàÿ ÷àñòü ïðîåêòà (ðèñ. 9) äîñòóïíà âñåì çàèíòåðåñîâàííûì ëèöàì íà ñòðàíèöå îôèöèàëüíîãî ñàéòà îðãàíèçàöèè [11]. Ìåæäó òåì, ñóùåñòâóþùèå ðàçëè÷íîãî ðîäà ðååñòðû ÑÎ íå âñåãäà îáåñïå÷èâàþò ïîäðîáíîé èíôîðìàöèåé îá èõ ôèçèêî-õèìè÷åñêèõ ñâîéñòâàõ è ìåòðîëîãè÷åñêèõ õàðàêòåðèñòèêàõ.

5
British Pharmacopoeia. Reference Standards Catalogue. Available from: https:// www.pharmacopoeia.com/Catalogue/Products.
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    of Medicines, Åâðîïåéñêèé äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ) [4]. Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ
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    , â USP — áîëåå 3500 [6]. ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

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    Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] Ðèñ. 5.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå British Pharmacopoeia
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    áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.  íàñòîÿùåå âðåìÿ USP ïðåäëàãàåò áîëåå 3500 ÑÎ ôàðìàöåâòè÷åñêèõ ñóáñòàíöèé, âñïîìîãàòåëüíûõ âåùåñòâ, ïðèìåñåé, ïèùåâûõ èíãðåäèåíòîâ, ïðîäóêòîâ ðàçëîæåíèÿ, ïèùåâûõ äîáàâîê, ôàðìàêîïåéíûõ ðåàêòèâîâ è äð.

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    Êà÷åñòâåííî ðåàëèçîâàí ìåõàíèçì ïðîñëåæèâàåìîñòè: âî-ïåðâûõ, ïðåäñòàâëåíû ïðåäûäóùèé íîìåð ëîòà è äàòà çàâåðøåíèÿ åãî ñðîêà èñïîëüçîâàíèÿ (òàêèì îáðàçîì ìîæíî ïîäòâåðäèòü ãîäíîñòü ÑÎ íà ìîìåíò ïðîâåäåíèÿ àíàëèçà ñ åãî ó÷àñòèåì); âî-âòîðûõ, èìåþòñÿ ññûëêè íà ÑÎ, êîòîðûå áûëè èñïîëüçîâàíû ïðè àòòåñòàöèè äàííîãî (ðèñ. 4). Íà îôèöèàëüíîì ñàéòå BP
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    ðàçìåùåí êàòàëîã õèìè÷åñêèõ ÑÎ Áðèòàíñêîé ôàðìàêîïåè (British Pharmacopoeia chemical reference substances, BPCRS) (ðèñ. 5). Èíòåðôåéñ ðåñóðñà ïðåäñòàâëÿåò ïåðå÷åíü ðåàëèçóåìîé ïðîäóêöèè, ïàíåëü áûñòðîãî ïåðåìåùåíèÿ ïî êàòàëîãó è èíñòðóìåíòû çàêàçà îáðàçöîâ â «êîðçèíó».

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    Ñîäåðæèò ïîäðîáíîå íîìåíêëàòóðíîå îïèñàíèå è ïåðå÷èñëåíèå õàðàêòåðèñòèê ýòàëîííîãî ìàòåðèàëà, óñëîâèÿ ïðèìåíåíèÿ è ïðî÷óþ èíôîðìàöèþ; Ðèñ. 6.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå British Pharmacopoeia
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    – ññûëêà íà ìîíîãðàôèè BP, â êîòîðîé óêàçàí äàííûé îáðàçåö (ìàòåðèàëû äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì, îïëàòèâøèì óñëóãó). Îáùèå ïîäõîäû ê èíôîðìàöèîííîìó îáåñïå÷åíèþ ïîëüçîâàòåëÿ, â öåëîì, àíàëîãè÷íû Ph.

6
United States Pharmacopoeia. Search and Buy Reference Standards. Available from: https:// goo.gl/UMNBVt.
Total in-text references: 6
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    äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ) [4]. Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ [5], â USP — áîëåå 3500
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    . ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

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    USP íå ÿâëÿåòñÿ ãîñóäàðñòâåííûì îðãàíîì, ïðè ýòîì òåñíî ñîòðóäíè÷àåò ñ ïðàâèòåëüñòâåííûìè ó÷ðåæäåíèÿìè è ðåãóëÿòîðíûìè îðãàíàìè âî âñåì ìèðå. Ñòàíäàðòû USP þðèäè÷åñêè ïðèçíàíû â ÑØÀ è äðóãèõ ñòðàíàõ è èñïîëüçóþòñÿ áîëåå ÷åì â 140 ñòðàíàõ
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    . Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] Ðèñ. 5.

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    Ñòàíäàðòû USP þðèäè÷åñêè ïðèçíàíû â ÑØÀ è äðóãèõ ñòðàíàõ è èñïîëüçóþòñÿ áîëåå ÷åì â 140 ñòðàíàõ [6]. Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP
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    Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] Ðèñ. 5.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå British Pharmacopoeia [5] áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.

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    Ñòàíäàðòû USP þðèäè÷åñêè ïðèçíàíû â ÑØÀ è äðóãèõ ñòðàíàõ è èñïîëüçóþòñÿ áîëåå ÷åì â 140 ñòðàíàõ [6]. Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP
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    Ðèñ. 5.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå British Pharmacopoeia [5] áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.  íàñòîÿùåå âðåìÿ USP ïðåäëàãàåò áîëåå 3500 ÑÎ ôàðìàöåâòè÷åñêèõ ñóáñòàíöèé, âñïîìîãàòåëüíûõ âåùåñòâ, ïðèìåñåé, ïèùåâûõ èíãðåäèåíòîâ, ïðîäóêòîâ ðàçëîæåíèÿ, ïèùåâûõ äîáàâîê, ôàðìàêîïåéíûõ ðåàêòèâîâ è äð.

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    USP òàêæå ïðåäîñòàâëÿåò ÑÎ, ïåðå÷èñëåííûå â Êîäåêñå ïèùåâûõ õèìè÷åñêèõ âåùåñòâ (Food Chemicals Codex), è àóòåíòè÷íûå âåùåñòâà, ÿâëÿþùèåñÿ âûñîêîêà÷åñòâåííûìè õèìè÷åñêèìè ýòàëîíàìè, äëÿ èñïîëüçîâàíèÿ àíàëèòè÷åñêèìè, êëèíè÷åñêèìè, ôàðìàöåâòè÷åñêèìè è èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè
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    .  ðàçäåëå «Reference Standards »íà ñàéòå USP [6] ïðåäñòàâëåíî íåñêîëüêî òåìàòè÷åñêèõ ñòðàíèö, îïèñûâàþùèõ ÑÎ USP, ññûëêè äëÿ çàãðóçêè ïîëíîãî òàáëè÷íîãî ïåðå÷íÿ ðåàëèçóåìûõ ñòàíäàðòíûõ îáðàçöîâ. Èíòåðàêòèâíàÿ ôîðìà ðàáîòû ñ êàòàëîãîì ïðåäñòàâëåíà â èíäèâèäóàëüíîì ïîäðàçäåëå.

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    USP òàêæå ïðåäîñòàâëÿåò ÑÎ, ïåðå÷èñëåííûå â Êîäåêñå ïèùåâûõ õèìè÷åñêèõ âåùåñòâ (Food Chemicals Codex), è àóòåíòè÷íûå âåùåñòâà, ÿâëÿþùèåñÿ âûñîêîêà÷åñòâåííûìè õèìè÷åñêèìè ýòàëîíàìè, äëÿ èñïîëüçîâàíèÿ àíàëèòè÷åñêèìè, êëèíè÷åñêèìè, ôàðìàöåâòè÷åñêèìè è èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè [6].  ðàçäåëå «Reference Standards »íà ñàéòå USP
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    ïðåäñòàâëåíî íåñêîëüêî òåìàòè÷åñêèõ ñòðàíèö, îïèñûâàþùèõ ÑÎ USP, ññûëêè äëÿ çàãðóçêè ïîëíîãî òàáëè÷íîãî ïåðå÷íÿ ðåàëèçóåìûõ ñòàíäàðòíûõ îáðàçöîâ. Èíòåðàêòèâíàÿ ôîðìà ðàáîòû ñ êàòàëîãîì ïðåäñòàâëåíà â èíäèâèäóàëüíîì ïîäðàçäåëå.

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World Health Organization. International Chemical Reference Substances. Available from: https:// goo.gl/8tfBJS.
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    ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé
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    .  2016 ãîäó êîëè÷åñòâî ÑÎ, êîòîðûå îïèñàíû â ìîíîãðàôèÿõ Ph. Eur. (European Pharmacopoeia,Åâðîïåéñêàÿ ôàðìàêîïåÿ), ñîñòàâëÿëî îêîëî 3000. Ïîñëå èñïûòàíèé â ëàáîðàòîðèè ìàòåðèàëû, ïðåäëàãàåìûå äëÿ èñïîëüçîâàíèÿ â êà÷åñòâå ÑÎ, óòâåðæäàþòñÿ Êîìèññèåé Åâðîïåéñêîé ôàðìàêîïåè, ïîñëå ÷åãî, ïîëó÷èâ ñòàòóñ îôèöèàëüíûõ ÑÎ, ïîñòóïàþò â Îòäåë ñòàíäàðòíûõ îáðàçöîâ (Reference Standards and Samples Divisio

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Keitel S. The European Pharmacopoeia: bringing pharmaceutical standard harmonization to Europe. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2016; (2): 8–14 (in Russian).
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     íàñòîÿùåå âðåìÿ óòâåðæäàþòñÿ õèìè÷åñêèå ñòàíäàðòíûå îáðàçöû (CRS), áèîëîãè÷åñêèå ñòàíäàðòíûå îáðàçöû (BRP), à òàêæå ñòàíäàðòíûå ñïåêòðû äëÿ èñïûòàíèé è àíàëèçîâ, âûïîëíÿåìûõ â ñîîòâåòñòâèè ñ îôèöèàëüíûìè ìåòîäàìè, îïèñàííûìè â Ph. Eur.
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    . Ñ 1992 ã. ââåäåíà ïðîöåäóðà ñîîòâåòñòâèÿ òðåáîâàíèÿì ìîíîãðàôèé Ph. Eur. Ñåðòèôèêàò ñîîòâåòñòâèÿ (Certificates of Suitability to the Monographs of the European Pharmacopoeia, CEP), âûäàííûé EDQM, ïîäòâåðæäàåò, ÷òî êà÷åñòâî ñóáñòàíöèè êîíòðîëèðóåòñÿ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ñîîòâåòñòâóþùåé ìîíîãðàôèè Ph.

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    Eur. è ìîæåò èñïîëüçîâàòüñÿ â êà÷åñòâå çàìåíû ïîäðîáÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur. [9] íîé èíôîðìàöèè, óêàçûâàåìîé â çàÿâêå íà ïîëó÷åíèå ðåãèñòðàöèîííîãî óäîñòîâåðåíèÿ ËÑ
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    . Ñòðàíèöà ñàéòà EDQM «Ph. Eur. Reference Standards: Orders &Catalogue »ïðåäîñòàâëÿåò ïîëüçîâàòåëÿì âîçìîæíîñòü ñâîáîäíîãî äîñòóïà ê åæåäíåâíî îáíîâëÿþùèìñÿ êàòàëîãó ÑÎ â ôîðìàòå PDF è áàçå äàííûõ ÑÎ â ðåæèìå îíëàéí (ðèñ. 1).

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European Directorate for the Quality of Medicines. Reference Substances. Available from: https:// goo.gl/VLo2zh.
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    Ñåðòèôèêàò ñîîòâåòñòâèÿ (Certificates of Suitability to the Monographs of the European Pharmacopoeia, CEP), âûäàííûé EDQM, ïîäòâåðæäàåò, ÷òî êà÷åñòâî ñóáñòàíöèè êîíòðîëèðóåòñÿ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ñîîòâåòñòâóþùåé ìîíîãðàôèè Ph. Eur. è ìîæåò èñïîëüçîâàòüñÿ â êà÷åñòâå çàìåíû ïîäðîáÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur.
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    Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur. [9] íîé èíôîðìàöèè, óêàçûâàåìîé â çàÿâêå íà ïîëó÷åíèå ðåãèñòðàöèîííîãî óäîñòîâåðåíèÿ ËÑ [8]. Ñòðàíèöà ñàéòà EDQM «Ph. Eur. Reference Standards: Orders &Catalogue »ïðåäîñòàâëÿåò ïîëüçîâàòåëÿì âîçìîæíîñòü ñâîáîäíîãî äîñòóïà ê åæåäíåâíî îáíîâëÿþùèìñÿ êàòàëîãó ÑÎ â ôîðìàòå PDF è áàçå äàííûõ ÑÎ â ðåæèìå îíëàéí (ðèñ. 1).

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    Eur. è ìîæåò èñïîëüçîâàòüñÿ â êà÷åñòâå çàìåíû ïîäðîáÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur.
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    íîé èíôîðìàöèè, óêàçûâàåìîé â çàÿâêå íà ïîëó÷åíèå ðåãèñòðàöèîííîãî óäîñòîâåðåíèÿ ËÑ [8]. Ñòðàíèöà ñàéòà EDQM «Ph. Eur. Reference Standards: Orders &Catalogue »ïðåäîñòàâëÿåò ïîëüçîâàòåëÿì âîçìîæíîñòü ñâîáîäíîãî äîñòóïà ê åæåäíåâíî îáíîâëÿþùèìñÿ êàòàëîãó ÑÎ â ôîðìàòå PDF è áàçå äàííûõ ÑÎ â ðåæèìå îíëàéí (ðèñ. 1).

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Borisevich IV, Petukhov VG, Volkova RA, Ustinnikova OB, Fadeikina OV, Malkova VI. Standard samples as a tool to provide metrology of analytical methods of immunobiological medicines (IM) monitoring. BIOpreparations. Prevention, Diagnosis, Treatment 2010; (4): 8–10 (in Russian).
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    Ó÷ðåæäåíèå ïîëó÷èëî ñòàòóñ Ìåæäóíàðîäíîé ëàáîðàòîðèè áèîëîãè÷åñêèõ ñòàíäàðòîâ ÂÎÇ è ïî ñåé äåíü ÿâëÿåòñÿ îôèöèàëüíîé Ëàáîðàòîðèåé êîíòðîëÿ ìåäèöèíñêèõ ïðåïàðàòîâ â Åâðîïå è Àíãëèè. Îí ïðîèçâîäèò áîëåå 90 % ìåæäóíàðîäíûõ ÑÎ äëÿ øèðîêîãî ñïåêòðà ãðóïï âåùåñòâ, âêëþ÷àÿ àíòèáèîòèêè, ôåðìåíòû, èììóíîáèîëîãè÷åñêèå ïðåïàðàòû, âèðóñíûå ïðåïàðàòû è êîìïîíåíòû êðîâè
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    . Èíòåðàêòèâíûé êàòàëîã ïðîäóêöèè ðàçìåùåí íà ñàéòå ó÷ðåæäåíèÿ â ðàçäåëå «Biological reference materials»; ïîñåòèòåëü ðåñóðñà ìîæåò èçó÷èòü ïîëíûé ñïèñîê çàïèñåé, ïðîêðó÷èâàÿ ñòðàíèöó, âîñïîëüçîâàòüñÿ íàâèãàöèîííî-ïîèñêîâîé ñèñòåìîé áðàóçåðà èëè ñàéòà.

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Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation. Expertise. Provision with standard samples and pathogenic strains. Available from: http://www.regmed.ru (in Russian).
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    ÊîìÐèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC [4] Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC [4] ìåð÷åñêàÿ ÷àñòü ïðîåêòà (ðèñ. 9) äîñòóïíà âñåì çàèíòåðåñîâàííûì ëèöàì íà ñòðàíèöå îôèöèàëüíîãî ñàéòà îðãàíèçàöèè
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    . Ìåæäó òåì, ñóùåñòâóþùèå ðàçëè÷íîãî ðîäà ðååñòðû ÑÎ íå âñåãäà îáåñïå÷èâàþò ïîäðîáíîé èíôîðìàöèåé îá èõ ôèçèêî-õèìè÷åñêèõ ñâîéñòâàõ è ìåòðîëîãè÷åñêèõ õàðàêòåðèñòèêàõ. Òàêèì îáðàçîì, ñîçäàíèå èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû

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    -àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû, à, ñ äðóãîé ñòîðîíû — ïîâûøåíèÿ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè [12]. Ðèñ. 9.Ôðàãìåíò ïåðå÷íÿ ðåàëèçóåìûõ îòðàñëåâûõ ñòàíäàðòíûõ îáðàçöîâ ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè
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    Íà îñíîâàíèè ïðîâåäåííîãî àíàëèçà îïðåäåëåíû îñíîâíûå èíôîðìàöèîííûå áëîêè, êîòîðûå öåëåñîîáðàçíî âêëþ÷èòü ïðè ðàçðàáîòêå èíôîðìàöèîííîàíàëèòè÷åñêîé áàçû ÑÎ: – íàèìåíîâàíèå ÑÎ (íîìåð ÑÎ, íîìåð ñåðèè); – èñòîðèÿ ÑÎ (ò.å. âîçìîæíîñòü ïðîñëåæèâàòü ìàòåðèàëû, èñïîëüçîâàííûå ïðè àòòåñòàöèè ïðåäûäóùèõ ñåðèé); – ïàêåò ñîïðîâîäèòåëüíûõ äîêóìåíòîâ (êòî ÿâëÿåòñÿ ïîñòàâùèêîì îáðàçöà äëÿ àòòåñòàöèè, íàèìåíîâ

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Improvement of the system of development and application of standard samples intended for assessing the quality, efficacy and safety of medicinal products. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Sakanyan EI, Klimov VI, Volkova RA; prepared by: Yashkir VA, Fadeikina OV. Mos-
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    Òàêèì îáðàçîì, ñîçäàíèå èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû, à, ñ äðóãîé ñòîðîíû — ïîâûøåíèÿ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè
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    . Ðèñ. 9.Ôðàãìåíò ïåðå÷íÿ ðåàëèçóåìûõ îòðàñëåâûõ ñòàíäàðòíûõ îáðàçöîâ ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè [11] Íà îñíîâàíèè ïðîâåäåííîãî àíàëèçà îïðåäåëåíû îñíîâíûå èíôîðìàöèîííûå áëîêè, êîòîðûå öåëåñîîáðàçíî âêëþ÷èòü ïðè ðàçðàáîòêå èíôîðìàöèîííîàíàëèòè÷åñêîé áàçû ÑÎ: – íàèìåíîâàíèå ÑÎ (íîìåð ÑÎ, íîìåð ñåðèè); – èñòîðèÿ ÑÎ (ò.å. âîçìîæíîñòü ïðîñëåæèâàòü ìàòåðèàëû, èñïîëüçîâàííûå ïðè àòòåñòàöèè ïðåäûäóù