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[國內外GMP法規及其指南]
持續工藝確認SOP和報告

      

 
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药生

      

      
      		


      


81#


      

      

      

      

 樓主|
发表于 2015-11-27 09:20:39
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      Suvilian 发表于 2015-11-26 21:14
      
你的SOP里面的包括 的内容部分跟年度质量回顾重叠了。
      
我们计划持续工艺确认全部工作都交给生产部做，主要 ...

      
附錄裏把工藝驗證詳細的分爲幾個部分，即包括：首次驗證、工藝變更的驗證、必要的對關鍵工藝的定期再驗證，以及持續工藝確認。
      
那麽我認爲持續工藝確認就是爲了確保工藝實施條件沒有發生變化或者得到有效控制、質量趨勢沒有發生異常或發生異常時采取必要的預防措施。
      

      



      

      

      點評
      

      


      
李老師說持續工藝確認包括首次驗證、工藝變更的驗證、再驗證及持續監控 

发表于 2015-12-5 22:01

      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


82#


      

      

      

      

发表于 2015-11-27 09:23:13
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學習了學習了學習了學習了學習了
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


83#


      

      

      

      

发表于 2015-11-27 13:15:08
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學習分享謝謝，
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


84#


      

      

      

      

发表于 2015-11-27 13:17:29
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不錯，學習一下。
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      

      
      		


      


85#


      

      

      

      

发表于 2015-11-27 13:31:26
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給個機會學習下呗！
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


86#


      

      

      

      

发表于 2015-11-27 15:53:06
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Thanks for sharing
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      

      
      		


      


87#


      

      

      

      

发表于 2015-11-27 15:53:22
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學習一下，謝謝樓主了
      

      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


88#


      

      

      

      

发表于 2015-11-27 15:55:31
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與年度産品質量回顧有何本職上區別？異常趨勢的判斷原則是什麽？
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


89#


      

      

      

      

发表于 2015-11-27 15:57:24
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看看新的課題
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      

      
      		


      


90#


      

      

      

      

发表于 2015-11-27 16:24:29
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參考下，與我們自己寫的看看有多少理解上的差距
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
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91#


      

      

      

      

发表于 2015-11-27 18:31:58
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      牧戎遠 发表于 2015-11-27 09:14
      
因为是初稿，只是拟定了目标内容。我的初衷是把我们已有的质量趋势控制和质量回顾结合起来，并确认工艺实 ...

      
其實GMP檢查或審核，最忌諱的是找理由說爲什麽沒做到
      
Just do it!
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


92#


      

      

      

      

发表于 2015-11-27 18:36:58
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學習了謝謝
      

      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


93#


      

      

      

      

发表于 2015-11-27 18:55:23
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持續工藝確認SOP和報告
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


94#


      

      

      

      

发表于 2015-11-27 19:44:54
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謝謝，周末愉快
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


95#


      

      

      

      

发表于 2015-11-28 07:10:08
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药徒

      

      
      		


      


96#


      

      

      

      

发表于 2015-11-28 08:45:40
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學習一下，謝謝分享。
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      

      
      		


      


97#


      

      

      

      

发表于 2015-11-28 08:49:53
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如果您要查看本帖隐藏内容請
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      



      

      

      


      
药徒

      

      
      		


      


98#


      

      

      

      

发表于 2015-11-28 09:09:24
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thanks for sharing
      



      

      

      


      



      

      


      

      


      

      

      





      

      





      

      

      

      
 

      

      


      


      

      

      

      
      		


      


99#


      

      

      

      

发表于 2015-11-28 09:14:10
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100#


      

      

      

      

发表于 2015-11-28 09:58:57
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學習、學習。
      



      

      

      


      



      

      


      

      

      		

      

      

      





      

      





      

      

      

      



      






      







      



      

      

      

      








      

      

      


      

      
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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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