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微生物檢查用培養基，是否需要進行每個滅菌批次的培養基適用性檢查？

      

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樓主


      

      

      

      

發表于 2025-8-14 12:09:50
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      若進行批批培養基適用性檢查，每次都使用中檢院對照培養基的話，是不是太浪費了，有沒有其他更合規合適的方法呢
      

      




      


      
單選投票, 共有 35 人参与投票

      




      


      

      





      


      


      

      

      
      		
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批量搞大點啊 

發表于 2025-8-14 14:05

      

      

      


      



      

      


      

      


      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
大师

      

      
      		


      


沙發


      

      

      

      

發表于 2025-8-14 12:22:08
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作为药学和医疗器械领域的专家，针对您的问题回複如下：
      

      
根據《中國藥典》2020年版四部9203《藥品微生物實驗室質量管理指導原則》，若采用已驗證的配制和滅菌程序且過程受控，同一批脫水培養基的適用性檢查試驗可僅進行1次，無需每個滅菌批次都做。若批批使用中檢院對照培養基確實成本過高，可采用實驗室通過驗證的自制培養基（配合陽性對照），在符合法規的前提下實現合規替代。
      

      
建議建立穩定的培養基制備標准操作流程並定期確認其性能，既能保證檢驗質量又可降低成本。
      

      
【鼠鼠還在學習中，內容僅供參考（藥搭GMP軟件提供技術支持）】
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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板凳


      

      

      

      

發表于 2025-8-14 12:47:28
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如果不使用中檢院的，審計或評審的時候，審計官認不認可呢
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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地板


      

      

      

      

 樓主|
發表于 2025-8-14 13:43:18
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      機智鼠 發表于 2025-8-14 12:22
      
作为药学和医疗器械领域的专家，针对您的问题回複如下：
      

      
根据《中国药典》2020年版四部9203《药品微生物实 ...

      
25版中國藥典，將這句取消了，換成“每批商品化的預制培養基、由脫水培養基或按處方配制的培養基均應符合培養基適用性檢查的要求”。這句話，如何理解呢？是對20版藥典的總結概括，還是又提出了新的要求。根據USP要求，他們確實是每個滅菌批進行培養基是適用性檢查。如果CHP向他們靠攏的話，是不是可以理解成每個滅菌批進行培養基適用性檢查呢》？
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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5#


      

      

      

      

發表于 2025-8-14 16:28:07
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我們就藥典裏面要求做培養基適用性的那幾款培養基按滅菌批做適用性，其他的比如稀釋液我們就不做適用性了，畢竟藥典沒要求
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药生

      

      
      		


      


6#


      

      

      

      

發表于 2025-8-14 20:26:43
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一次多做幾批
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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7#


      

      

      

      

發表于 2025-9-11 11:23:09
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多做幾批，驗證存放有效期是多久
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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8#


      

      

      

      

發表于 2025-10-23 16:15:04
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9#


      

      

      

      

發表于 2025-10-31 08:55:56
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過了一個國慶節，原來一直用的培養基，要重新做適用性檢查
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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10#


      

      

      

      

發表于 2025-10-31 09:24:40
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一次多做幾批保存涉及保存条件、保存期限、保存条件偏离在线报警、偏差处理等因素，要真正做好比较有难度。
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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11#


      

      

      

      

發表于 2025-10-31 09:33:28
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 本帖最后由 心若菩提靜若枯 于 2025-10-31 10:02 编辑 
      

      Hilary1 發表于 2025-8-14 13:43
      
25版中国药典，将这句取消了，换成“每批商品化的预制培养基、由脱水培养基或按处方配制的培养基均应符合 ...

      
  1105这句话 我的理解是每进货批做适用性即可  什么是商品化  我的理解是可以作为销售完整的产品才是商品化的培养基  而且我们使用过程中分装了多个批次 不能算为商品化的 若不然我分装后退回去 厂家也不能当做单独销售。
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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12#


      

      

      

      

發表于 2025-11-3 15:32:43
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      Hilary1 發表于 2025-8-14 13:43
      
25版中国药典，将这句取消了，换成“每批商品化的预制培养基、由脱水培养基或按处方配制的培养基均应符合 ...

      
目前我了解的解答是要提高培養基適用性的頻率，至少要比25版實行前的頻率要高，至于用不用每批都做，目前沒有強制要求。
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      

      
      		


      


13#


      

      

      

      

發表于 6 天前
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      牛牛默默 發表于 2025-11-3 15:32
      
目前我了解的解答是要提高培养基适用性的频率，至少要比25版实行前的频率要高，至于用不用每批都做，目前 ...

      
從哪個渠道了解的？
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      



      






      






      



      

      

      

      








      

      

      


      

      
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 A JAPANESE AT HIS TOILET FOR A VISIT OF CEREMONY. A JAPANESE AT HIS TOILET FOR A VISIT OF CEREMONY. Top-side Galah! I prompted Camille to ask if he had ever encountered Ned Ferry, and he laughed. "But if she should be at Wiggins--" "And there is the whole trouble," I added. "She will not let you marry the woman whose--" A port crowded with steamers taking in coal, and very light barks high out of the water, kept in equilibrium by parallel outriggers at the ends of two flexible spars. These crank boats, made of[Pg 124] planks that scarcely overlap, were piled with luggage, and the boatmen jostle and turn and skim close under the fast-steaming transatlantic liners, amid a bewildering babel of shouts and oaths, under a sun hot enough to melt lead.     97 “You tell me who knew the way to get into the captain’s safe and I’ll try to get the emeralds.”  The reporter interposed that it was the act of men maddened by grief and their losses. [Pg 86] He turned his chair and studied her in a kind of hopeless amusement. "Felipa," he said, "if you will insist upon being told, I cut open the pockets of those dead men's clothes with it."  JOSIAH KLEGG, ESQ.,  "Did you raid the establishment of a person named"  "You drunken maverick," answered Billings, trying to brave it out. "I'll have you shot for insultin' and threatenin' your sooperior officer. Skip out o' here before the Provo comes up and ketches you. Let me go on about my business. Forward, boys."    "Of course you did. I—I gave myself away. I pleaded with you." That same day, Calverley summoned, or rather packed, a jury at which he himself presided; and a verdict of wilful murder was returned against Edith. Apprehensive, however, that the charge of poisoning might not be sustained upon the unsupported testimony of Mary Byles, he easily influenced the credulous jurors to believe that witchcraft had as much to do with the child's death as poison. His usual tact, however, had forsaken him on this occasion, and it was not until the verdict was announced and recorded, that the unwelcome conviction flashed across his mind, that the temporal courts could exercise no jurisdiction over the crime of witchcraft. It was now too late to alter the language of the inquisition. It had gone forth to hundreds who awaited its promulgation with intense anxiety; and the language of the verdict that "Edith Holgrave delivered to Mary Byles, a certain charmed or poisonous drug, for the purpose of destroying Roland De Boteler, and which said drug was administered to, and caused the death of, the said Roland," was, in a few hours, familiar to the whole town and neighbourhood.  Xi extends condolences over Hong Kong building fire, urges all-out rescue efforts to minimize losses
(Xinhua) 08:02, November 27, 2025
BEIJING, Nov. 26 (Xinhua) -- Chinese President Xi Jinping on Wednesday extended condolences over a deadly residential building fire in Hong Kong, which killed at least 13 people.

Xi, also general secretary of the Communist Party of China (CPC) Central Committee and chairman of the Central Military Commission, expressed sympathy to the families of the victims and those affected by the disaster. He urged all-out efforts to extinguish the fire and minimize casualties and losses.

In the wake of the fire, Xi attached great importance to the accident and immediately sought updates on the rescue efforts and casualties.

Xi instructed the director of the Liaison Office of the Central People's Government in the Hong Kong Special Administrative Region (HKSAR) to convey his condolences and sympathies to HKSAR Chief Executive John Lee.

He required the Hong Kong and Macao Work Office of the CPC Central Committee and the liaison office to support the HKSAR government in making all-out efforts to put out the fire, do everything possible in search and rescue, treat the injured, and comfort the victims' families.

(Web editor: Zhang Kaiwei, Du Mingming)
China releases white paper on arms control in new era
(Xinhua) 10:19, November 27, 2025
BEIJING, Nov. 27 (Xinhua) -- China's State Council Information Office on Thursday released a white paper titled "China's Arms Control, Disarmament, and Nonproliferation in the New Era."

The white paper said that China plays a constructive role in international arms control, disarmament, and nonproliferation, and actively offers its initiatives and solutions.

China has been and will always be a builder of world peace, a contributor to global development, and a defender of the international order, it said.

The white paper was released to comprehensively present China's policies and practices on arms control, disarmament, and nonproliferation, and its position on security governance in emerging fields such as outer space, cyberspace, and artificial intelligence.

It was also to restate China's commitment to safeguarding world peace and security, and to call on countries around the world to work together for international arms control.

The white paper noted that China is committed to upholding the international arms control regime with the United Nations (UN) at its core. It works to promote global governance in arms control, supports all efforts to build a world of lasting peace and common security, and serves as a key promoter of international arms control.

It also noted that as a permanent member of the UN Security Council, China has actively safeguarded the authority and effectiveness of the international arms control regime, played a constructive role in multilateral arms control in the nuclear, biological, chemical and other fields, and conscientiously performed its duties prescribed by international arms control treaties, making its due contribution to international arms control.

Emerging fields such as outer space, cyberspace, and AI represent new frontiers for human development. They create a new focus of strategic security, and new territories of global governance, the white paper pointed out.

China proposes that with the universal participation of all countries, the UN should play a pivotal role in fostering a global governance framework and standards for emerging fields based on broad consensus, while increasing the representation and voice of developing countries, it added.

The white paper stressed that China continues to build its domestic nonproliferation capacity, actively participating in the international nonproliferation process, promoting international cooperation on peaceful uses of science and technology, and facilitating the improvement of global nonproliferation governance.

Chinese modernization follows the path of peaceful development, and China's growth contributes to the growth of the world's peaceful forces. China stands ready to work with all peace-loving countries to build an equal and orderly multipolar world and promote universally beneficial and inclusive economic globalization. It will consolidate and develop the UN-centered international arms control regime, work with all parties to build a community with a shared future for humanity, and create a brighter future for all, according to the white paper.
The Chinese Foreign Ministry on Tuesday said the atmosphere of the phone call between Chinese President Xi Jinping and U.S. President Donald Trump on Monday was "positive, friendly, and constructive." 

At a regular press briefing on Tuesday, Foreign Ministry spokesperson Mao Ning confirmed that the U.S. side had initiated the call. She noted that since the start of President Trump's second term, the two leaders have maintained frequent communication. 

Mao said the two heads of state exchanged views on issues of mutual concern, stressing that such communication is vital for the stable development of China鈥揢.S. relations.
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