20xx年醫(yī)學(xué)專題—仿制藥分析方法的驗(yàn)證和藥品穩(wěn)定性的研究--譚海松20xx1127-閱讀頁(yè)
2024-11-04 17:28本頁(yè)面
【正文】 大體積包裝的制劑:靜脈輸液 穩(wěn)定性試驗(yàn)所需總量的10倍以上,第六十八頁(yè)，共七十六頁(yè)。,哪些(nǎxiē)變化需要重測(cè)成品藥的穩(wěn)定性,不同的制劑和配方 改變主要添加劑的比例 改變生產(chǎn)步驟,生產(chǎn)設(shè)備(sh232。i)和生產(chǎn)地 改變藥品的包裝,第七十頁(yè)，共七十六頁(yè)。njiū)的特點(diǎn),周期長(zhǎng) 樣品選擇較嚴(yán)格(y225。) 重測(cè)率高 成本較高,第七十一頁(yè)，共七十六頁(yè)。njiū)的參考文獻(xiàn),ICH Q1A Stability Testing of New Drug Substances and Products ICH Q1B Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q3 Impurities,第七十二頁(yè)，共七十六頁(yè)。),Your firm invalidated analytical data without any scientific justification Your investigation attributes an unknown peak to injector contamination but this peak was not present in previous system suitability or sample injections Your corrective action addresses product disposition but does not address how to prevent reoccurrence of the OOS result,第七十三頁(yè)，共七十六頁(yè)。),Stability failures were attributed to inexperienced analysts when expert analysts repeated the results and obtained passing results. The batch was released on retest data without justification for ignoring the original results. The Quality Unit was unaware of the original failing results. Laboratory investigation and corrective actions were not completed in a timely manner.,第七十四頁(yè)，共七十六頁(yè)。),Some reagents, buffer solutions, reference compound, and water used for analysis, present in the laboratory area, were not appropriately labeled, were expired or carried no expiry date. Refrigerator does not have temperature recorder for 24 hours. SOP does not define freezer temperature (e.g. below 10C). Use of protective clothing in the laboratory area is not described in an SOP. The qualification records of the computer administrator are not complete and the job description is not available.,第七十五頁(yè)，共七十六頁(yè)。ir243。如生產(chǎn)廠家沒有提供有效期, SOP要規(guī)定有效期。色譜峰的容量因子: 1k20。檢測(cè)限和定量限信噪比的測(cè)量。不同緩沖液可放在不同容器中。ngm249。綜合加速試驗(yàn)和長(zhǎng)期試驗(yàn)結(jié)果進(jìn)行統(tǒng)計(jì)
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