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關(guān)于原輔料的檢驗(yàn)頻次和內(nèi)容的一些規(guī)定
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有一天開(kāi)會(huì)提到一個(gè)問(wèn)題是否可以減少進(jìn)場(chǎng)原輔料的檢驗(yàn)頻次和內(nèi)容。因?yàn)槲覀儸F(xiàn)在的進(jìn)場(chǎng)原輔料實(shí)在是太多，而且由于生產(chǎn)計(jì)劃和采購(gòu)計(jì)劃的不協(xié)調(diào)導(dǎo)致所有的壓力都在QC和倉(cāng)庫(kù)。后來(lái)上網(wǎng)搜索了一下發(fā)現(xiàn)了一些端倪，共享給大家學(xué)習(xí)一下。但是中外的差異還是很大的。 FDA和ICH相關(guān)條文 21 CFR Section 211.84(d)： (d) Samples shall be examined and tested as follows: (1) At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used. (2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. (3) Containers and closures shall be tested for conformity with all appropriate written specifications. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals. (4) When appropriate, components shall be microscopically examined. (5) Each lot of a component, drug product container, or closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such contamination. (6) Each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. ICH Q 7 7.30 At least one test to verify the identity of each batch of material should be conducted, with the exception of the materials described below in 7.32. A supplier's Certificate of Analysis can be used in place of performing other tests, provided that the manufacturer has a system in place to evaluate suppliers. 7.31 Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications. Full analyses should be conducted on at least three batches before reducing in-house testing. However, as a minimum, a full analysis should be performed at appropriate intervals and compared with the Certificates of Analysis. Reliability of Certificates of Analysis should be checked at regular intervals. 7.32 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer’s Certificate of Analysis is obtained, showing that these raw materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers should help in establishing the identity of these materials. The lack of on-site testing for these materials should be justified and documented. 也就是說(shuō)，如果經(jīng)過(guò)前三批的全檢之后，經(jīng)過(guò)風(fēng)險(xiǎn)評(píng)估是可以根據(jù)自己的實(shí)際情況部分檢驗(yàn)，但是部分檢驗(yàn)中必須是要有至少一個(gè)鑒別的。然后隔一段時(shí)間做一次全檢即可。 但是國(guó)內(nèi)的要求又有不同 GMP第二百二十三條：“物料和不同生產(chǎn)階段產(chǎn)品的檢驗(yàn)應(yīng)當(dāng)至少符合以下要求：（一）企業(yè)應(yīng)當(dāng)確保藥品按照注冊(cè)批準(zhǔn)的方法進(jìn)行全項(xiàng)檢驗(yàn)�！边@里物料指的是原料、輔料和包裝材料。所以企業(yè)應(yīng)對(duì)直接接觸藥品的包裝材料進(jìn)行全項(xiàng)檢測(cè)，如你企業(yè)有些檢測(cè)實(shí)在無(wú)法做到，可以按有關(guān)規(guī)定進(jìn)行委托檢測(cè)。但你企業(yè)應(yīng)對(duì)檢測(cè)承擔(dān)責(zé)任。 也就是說(shuō)國(guó)內(nèi)的GMP要求進(jìn)場(chǎng)原輔料必須按照注冊(cè)標(biāo)準(zhǔn)進(jìn)行全檢。 |
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