The EDQM and the USP Convention dis

The EDQM and the USP Convention distribute pharmacopoeial primary reference standards (CRS, USPRS), which fulfil all the regulatory stipulations regarding EP and USP monographs (EDQM, 2012; United States Pharmacopeial Convention, 2012). In full consequence, this means that the standards can be used for their intended purpose but may not be suitable for any other purposes. "Where a reference standard is needed, it is an integral part of the pharmacopoeial monograph or the manufacturer’s specification. Where a European Pharmacopoeia reference standard is referred to in a monograph or general chapter, it represents the official standard that is alone authoritative in case of doubt or dispute." (EDQM, 2012 - Section 5.12) This specificity has been even officially recognised in the introduction of ISO Guide 34 (International Organization for Standardization, 2009). Any deviations regarding usage for other purposes than the one for which the standard has been established must therefore be documented and the user must fully demonstrate the suitability. Furthermore the predefinition "Any value assigned to a reference standard is valid for the intended use and not necessarily for other uses." causes the necessity to accomplish own analytical characterizations in this case. To the same extent, the USP states "The use of these materials is specified in the article’s monograph, and these materials generally are necessary for use in the Assay and/or the Identification tests. The suitability of a USP RS for uses outside those specified in a monograph is the responsibility of the user.(United States Pharmacopeial Convention, 2012, Section ) and of course, certified reference substances which are characterised completely in accordance with the regulatory requirements are frequently used for many other applications than those described in the pharmacopoeial
monographs. During the latest 11th International Symposium on Pharmaceutical Reference Standards in Strasbourg in September 2012 some differences between EP und USP with respect to their self-understanding of their mission became obvious. While USP also provides several reference standards not used in any of the USPNF monographs, the EDQM clearly defines its mission as providing reference standards solely for the purpose that its user can make unequivocal fail or pass decisions for the product analyzed by applying exactly the procedure as described in the corresponding EP monograph. Consequently, the EDQM has decided not to disclose data on the uncertainty values of the assigned content of its reference standards. This strategy is also recognized in ISO 34: “The measurement uncertainty associated to the content value of Ph. Eur. CRS is not stated since it is considered to be negligible in relation to the defined limits of the method-specific assays for which they are used” (International Organisation for Standardization, 2009; section 5.17). The reason for that strategy being, that the EDQM does not want the user of its reference standards to use such uncertainty data to make a product pass a test by re-calculating the test result including the uncertainty data, although the test result itself is outside of the specifications set in the respective monograph. Instead, the uncertainty of the reference standard content is already being included in the specifications of each monograph. In contrast to this approach of the EDQM, USP has started to provide uncertainty information for a growing number of reference standards.

Hasil (Bahasa Indonesia) 1:

The EDQM and the USP Convention distribute pharmacopoeial primary reference standards (CRS, USPRS), which fulfil all the regulatory stipulations regarding EP and USP monographs (EDQM, 2012; United States Pharmacopeial Convention, 2012). In full consequence, this means that the standards can be used for their intended purpose but may not be suitable for any other purposes. "Where a reference standard is needed, it is an integral part of the pharmacopoeial monograph or the manufacturer’s specification. Where a European Pharmacopoeia reference standard is referred to in a monograph or general chapter, it represents the official standard that is alone authoritative in case of doubt or dispute." (EDQM, 2012 - Section 5.12) This specificity has been even officially recognised in the introduction of ISO Guide 34 (International Organization for Standardization, 2009). Any deviations regarding usage for other purposes than the one for which the standard has been established must therefore be documented and the user must fully demonstrate the suitability. Furthermore the predefinition "Any value assigned to a reference standard is valid for the intended use and not necessarily for other uses." causes the necessity to accomplish own analytical characterizations in this case. To the same extent, the USP states "The use of these materials is specified in the article’s monograph, and these materials generally are necessary for use in the Assay and/or the Identification tests. The suitability of a USP RS for uses outside those specified in a monograph is the responsibility of the user.(United States Pharmacopeial Convention, 2012, Section <11>) and of course, certified reference substances which are characterised completely in accordance with the regulatory requirements are frequently used for many other applications than those described in the pharmacopoeialmonographs. During the latest 11th International Symposium on Pharmaceutical Reference Standards in Strasbourg in September 2012 some differences between EP und USP with respect to their self-understanding of their mission became obvious. While USP also provides several reference standards not used in any of the USPNF monographs, the EDQM clearly defines its mission as providing reference standards solely for the purpose that its user can make unequivocal fail or pass decisions for the product analyzed by applying exactly the procedure as described in the corresponding EP monograph. Consequently, the EDQM has decided not to disclose data on the uncertainty values of the assigned content of its reference standards. This strategy is also recognized in ISO 34: “The measurement uncertainty associated to the content value of Ph. Eur. CRS is not stated since it is considered to be negligible in relation to the defined limits of the method-specific assays for which they are used” (International Organisation for Standardization, 2009; section 5.17). The reason for that strategy being, that the EDQM does not want the user of its reference standards to use such uncertainty data to make a product pass a test by re-calculating the test result including the uncertainty data, although the test result itself is outside of the specifications set in the respective monograph. Instead, the uncertainty of the reference standard content is already being included in the specifications of each monograph. In contrast to this approach of the EDQM, USP has started to provide uncertainty information for a growing number of reference standards.

Hasil (Bahasa Indonesia) 2:

The EDQM dan Konvensi USP mendistribusikan standar farmakope referensi utama (CRS, USPRS), yang memenuhi semua ketentuan peraturan mengenai EP dan USP monograf (EDQM, 2012; Amerika Serikat Pharmacopeial Convention, 2012). Karena itu penuh, ini berarti bahwa standar dapat digunakan untuk tujuan mereka, tetapi mungkin tidak cocok untuk tujuan lain. "Dimana standar referensi yang dibutuhkan, itu adalah bagian integral dari monografi farmakope atau spesifikasi pabrikan. Dimana standar acuan Eropa Farmakope disebut dalam monografi atau bab umum, itu merupakan standar resmi yang sendirian otoritatif dalam kasus diragukan atau sengketa. " (EDQM 2012 - Bagian 5.12) spesifisitas ini telah bahkan secara resmi diakui dalam pengenalan ISO Guide 34 (Organisasi Internasional untuk Standardisasi, 2009). Setiap penyimpangan terkait penggunaan untuk tujuan lain dari yang untuk yang standar telah ditetapkan oleh karena itu harus didokumentasikan dan pengguna harus sepenuhnya menunjukkan kesesuaian. Selanjutnya predefinition "Apa nilai yang diberikan untuk standar referensi berlaku untuk penggunaan yang dimaksudkan dan bukan untuk kegunaan lain." menyebabkan perlunya untuk mencapai karakterisasi analitis sendiri dalam kasus ini. Pada tingkat yang sama, USP menyatakan "Penggunaan bahan ini ditentukan di monografi artikel, dan bahan-bahan ini umumnya diperlukan untuk digunakan dalam Assay dan / atau tes Identifikasi. Kesesuaian USP RS untuk keperluan di luar yang ditentukan di monografi adalah tanggung jawab pengguna. (Amerika Serikat Pharmacopeial konvensi 2012, Bagian <11>) dan tentu saja, zat referensi bersertifikat yang ditandai sepenuhnya sesuai dengan persyaratan peraturan yang sering digunakan untuk banyak aplikasi selain yang dijelaskan dalam farmakope
monograf. Selama terbaru 11 Simposium Internasional tentang standar referensi Farmasi di Strasbourg pada September 2012 beberapa perbedaan antara EP und USP sehubungan dengan adanya pemahaman diri dari misi mereka menjadi jelas. Sementara USP juga menyediakan beberapa standar referensi tidak digunakan dalam dari monograf USPNF, yang EDQM jelas mendefinisikan misinya sebagai menyediakan standar referensi semata-mata untuk tujuan yang penggunanya dapat membuat tegas gagal atau lulus keputusan untuk produk dianalisis dengan menerapkan persis prosedur seperti yang dijelaskan dalam EP monografi yang sesuai. Akibatnya, EDQM telah memutuskan untuk tidak mengungkapkan data tentang nilai-nilai ketidakpastian isi ditugaskan standar acuannya. Strategi ini juga diakui dalam ISO 34: "Pengukuran ketidakpastian terkait dengan nilai isi Ph Eur.. CRS tidak disebutkan karena dianggap diabaikan dalam kaitannya dengan batasan yang ditentukan dari tes metode khusus yang mereka digunakan "(Organisasi Internasional untuk Standardisasi, 2009; bagian 5.17). Alasan untuk itu strategi makhluk, bahwa EDQM tidak ingin pengguna dari standar acuan untuk menggunakan data ketidakpastian tersebut untuk membuat produk lulus ujian dengan re-menghitung hasil tes termasuk data ketidakpastian, meskipun hasil tes itu sendiri adalah luar dari spesifikasi yang ditetapkan dalam monografi masing. Sebaliknya, ketidakpastian konten standar acuan sudah termasuk dalam spesifikasi masing-masing monografi. Berbeda dengan pendekatan ini EDQM tersebut, USP telah mulai memberikan informasi ketidakpastian untuk semakin standar referensi.