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可以不按藥典標準放行嗎？

Pharmacopoeias play an important role in quality control. They define important standards and framework conditions for tests; they contain requirements for reagents and reference materials as well as specifications for active substances (APIs), excipients, packaging materials and medicinal products. In addition, pharmacopoeias also contain descriptions of all relevant test methods.

藥典在質(zhì)量控制中起著重要的作用。它們?yōu)闄z驗確定了重要的標準和框架條件；它包含試劑和標準物質(zhì)的要求，以及活性物質(zhì) (API)、輔料、包裝材料和醫(yī)藥成品的標準。此外，藥典還包含所有相關(guān)分析方法的描述。

As a rule, authorities expect products and materials to meet the requirements of pharmacopoeia monographs during their storage life. In the context of the differentiation established in Europe into release and shelf-life specifications, specifications in pharmacopoeias are therefore to be seen as shelf-life specifications. This means that if changes occur during storage, specifications for release may need to be made more stringent.

通常，當(dāng)局希望產(chǎn)品和物料在儲存期內(nèi)符合藥典個論的標準。在歐洲將產(chǎn)品標準分為放行標準和貨架期標準，藥典標準當(dāng)然將被視為貨架期標準。這意味著，如果藥品在儲存期間會發(fā)生變化，放行標準可能需要更加嚴格。

However, this does not mean that the performance of all tests set out in a monograph is always a mandatory prerequisite for the release of a product batch. For example, the manufacturer can ensure that a product meets the requirements of the monograph on the basis of data from validation studies of the manufacturing process and in-process controls, such as online or at-line monitoring. In some circumstances, such data may provide a better guarantee that a batch meets a specific requirement of a monograph than test data from the examination of a small number of units taken from that batch. Control of synthetic by-products after the production of the active substance may eliminate the need for testing for these impurities in the medicinal product. This of course only applies to impurities from the production of the active substances which cannot be degradation products at the same time.

但是，這并不意味著專論中規(guī)定的所有檢驗始終是產(chǎn)品批放行的強制性先決條件。例如，生產(chǎn)商可以根據(jù)生產(chǎn)過程和過程控制(如在線或近線監(jiān)測)的驗證研究數(shù)據(jù)，確保產(chǎn)品符合專論的要求。在某些情況下，此類數(shù)據(jù)可能比從該批次中抽取少量樣品的檢驗數(shù)據(jù)更能保證批次符合專論的要求。對活性物質(zhì)生產(chǎn)后的合成副產(chǎn)物的控制可以消除對藥品中這些雜質(zhì)的檢驗需求。這當(dāng)然只適用于不與活性物質(zhì)同一步驟產(chǎn)出的雜質(zhì)。

Furthermore, under conditions considered appropriate by the regulatory authority, parametric release is not excluded by the need to comply with the requirements of the pharmacopoeia.

此外，在經(jīng)監(jiān)管機構(gòu)批準的情況下，還可以采用參數(shù)放行。

In most pharmacopoeias, the tests and assays described in a monograph are official methods on which the pharmacopoeia standards are based. After regulatory approval (included in the submission to the authority), alternative analytical methods may be used for routine control purposes. However, this only applies on the condition that a clear decision is possible on the basis of the methods used as to whether fulfilment of the monograph standards would also be possible using the official methods. In case of doubt or dispute, the analysis methods set out in the relevant monograph are binding.

在大多數(shù)藥典中，專論中描述的檢驗和分析是官方的方法。在監(jiān)管批準后(包含在提交給當(dāng)局的文件中)，也可用替代分析方法進行日?？刂?。然而，這僅適用于能夠根據(jù)所使用的方法作出明確判定的條件，即是否通過官方方法也可以符合專論標準。如有疑問或爭議，將以藥典專論的分析方法為準。

Monographs for pharmaceutical active substances contain a section on description or characters, which also includes solubility data. These are informative in nature and do not constitute a requirement.

藥用活性物質(zhì)的專論包含關(guān)于簡介或特性的章節(jié)，其中還包括溶解度數(shù)據(jù)。這些只做信息用途，不構(gòu)成標準要求。

Pharmacopoeias contain general monographs whose requirements for reagents, reference standards, packaging, excipients and active substances and/or medicinal products should be met. Individual monographs contain specific requirements for an article, including additional points, and may extend limits for the requirements of a general monograph or provide for exceptions. The exact application of the general monographs is handled differently in the various pharmacopoeias. The USP provides for more comprehensive definitions in the individual product monographs.

藥典通論，包含關(guān)于試劑、對照標準、包裝、輔料和活性物質(zhì)和/或醫(yī)藥產(chǎn)品的要求應(yīng)符合。個別專論包含藥品的具體要求，包括附加要點，并可能超出通論的要求或作出例外規(guī)定。通論的精確應(yīng)用在各種藥典中有不同的處理方式。USP 在各個產(chǎn)品專著中規(guī)定了更全面的定義。

Biological macromolecules produced from cell cultures, such as monoclonal antibodies, represent a challenge for a pharmacopoeia.

細胞培養(yǎng)產(chǎn)生的生物大分子，如單克隆抗體，對藥典來說是一個挑戰(zhàn)。

In addition to the specifications, these substances are significantly characterised by the manufacturing process. Because pharmacopoeias are primarily based on specifications, a different approach with regard to monograph content is required for biological medicinal products, and this is still in development.

除了標準之外，這些物質(zhì)在生產(chǎn)過程中具有顯著的特點。由于藥典主要基于標準，生物醫(yī)藥產(chǎn)品需要對專論內(nèi)容采取不同的方法，而且這種方法仍在開發(fā)中。

可以不按藥典儲存嗎？

藥品的儲存條件首先按照藥品說明書上的要求進行保存，若說明書未標示具體溫度等條件，則按照《中華人民共和國藥典》規(guī)定的貯藏要求進行儲存。具體依據(jù)如下：

法規(guī)規(guī)定：《藥品經(jīng)營質(zhì)量管理規(guī)范》明確要求，企業(yè)應(yīng)當(dāng)根據(jù)藥品的質(zhì)量特性對藥品進行合理儲存，按包裝標示的溫度要求儲存藥品，包裝上沒有標示具體溫度的，按照《中華人民共和國藥典》規(guī)定的貯藏要求進行儲存。

說明書的重要性：藥品說明書是藥品上市許可持有人、藥品生產(chǎn)企業(yè)基于藥品的研發(fā)、生產(chǎn)等過程，對藥品的使用、儲存等各方面進行詳細說明的法定文件。其中的【貯藏】項是藥品儲存的直接依據(jù)，它針對該藥品的具體特性，給出了最準確、最合適的儲存條件，以確保藥品在有效期內(nèi)的質(zhì)量和穩(wěn)定性。比如硝酸甘油，說明書通常會明確要求遮光、密閉保存，這是因為硝酸甘油對光敏感，容易分解失效。

說明書上的儲存條件可以和藥典不一致，但需要有充分的依據(jù)和經(jīng)過相關(guān)部門的審批。

藥品說明書的儲存條件是根據(jù)藥品的穩(wěn)定性試驗結(jié)果制定的，應(yīng)確保藥品在規(guī)定的儲存條件下能夠保持其質(zhì)量、安全性和有效性。如果藥品的儲存條件與藥典不一致，企業(yè)需要提供充分的穩(wěn)定性研究數(shù)據(jù)和科學(xué)依據(jù)，證明該儲存條件能夠保證藥品的質(zhì)量和穩(wěn)定性。同時，企業(yè)還需要按照藥品注冊管理的相關(guān)規(guī)定，向藥品監(jiān)督管理部門提交補充申請，經(jīng)批準后方可變更說明書中的儲存條件。

真實案例：某產(chǎn)品在中國藥典中規(guī)定的儲存條件為：陰涼儲存（即≤20℃），該公司考慮到該產(chǎn)品在國外藥典儲存條件為：室溫（即15~25℃），通過查詢相關(guān)文獻，該產(chǎn)品可以支持常溫儲存，該公司在充分穩(wěn)定性試驗的條件下申報儲存條件變更為常溫保存，不同于藥典。