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      培養基灌裝是否需要做清潔驗證的可行性討論

      發布時間:

      2022-12-27

      作者:


      培養基灌裝是否需要做清潔驗證的可行性討論
       
       
      首先,我們需要確認的是,什么情況下,需要進行清潔驗證。根據GMP正文:“第一百四十三條 清潔方法應當經過驗證,證實其清潔的效果,以有效防止污染和交叉污染。清潔驗證應當綜合考慮設備使用情況、所使用的清潔劑和消毒劑、取樣方法和位置以及相應的取樣回收率、殘留物的性質和限度、殘留物檢驗方法的靈敏度等因素。”
       
      附錄:《驗證和確認》第三十九條  為確認與產品直接接觸設備的清潔操作規程的有效性,應當進行清潔驗證。應當根據所涉及的物料,合理地確定活性物質殘留、清潔劑和微生物污染的限度標準。
       
      總結一下兩個法規的規定,就是對于有可能產生污染和交叉污染(和產品直接接觸設備或區域)的清潔方法,為了證明清潔方法能夠有效的清除可能的污染和交叉污染,需要對清潔方法進行清潔驗證。
       
      培養基灌裝中,使用到的設備是會和產品直接接觸的,培養基是有可能會對產品產生污染的,所以培養基灌裝后的清潔方法是符合以上對于清潔驗證的要求,毫無疑問是需要進行驗證的,如果沒有做,肯定是不符合法規要求。
       
      那么該如何去做培養基灌裝后的清潔驗證呢?因為清潔驗證,針對的是清潔程序,所以也分為以下情況來分析:
       
      一. 培養基灌裝后的清潔方式和產品生產后的清潔方式一致
       
      在這種情況下,你需要做的是在你原始的清潔驗證方案中,將培養基當成是你的產品來進行分析,分析各類產品的溶解性、毒性指標等,然后再來確定清潔驗證的目標物,選擇殘留限度和檢測方法。這個并不需要單獨針對培養基灌裝的清潔寫方案。
       
      二.培養基灌裝后的清潔方式和產品生產后的清潔方式不一致
       
      在這種情況下,你需要單獨起草方案,方案的內容和要求和清潔驗證的一樣,確定殘留限度和檢驗方法。怎么去做,不在這里討論,因為這是技術活,每個公司的選擇都不同,以后有時間再討論了。
       
      有朋友也會問了,我培養基灌裝一年才做兩次,那么這個清潔驗證要怎么做呢,是否可以用清潔確認代替清潔驗證?首先,對于新建藥廠的朋友,就不用說了,培養基灌裝要做三次,你有足夠的時間和批次做這個驗證。
       
            如果是沒有做過,現在需要補充做的朋友呢?首先,清潔驗證要求你做三次,沒規定你到底需要做多久啊?三次也就一年半時間,你做完一次,寫一個階段性的報告不可以么?做完三次,再出一個報告,不可以么?
       
      其次,雖然附錄49條說“對于處于研發階段的藥物或不經常生產的產品,可采用每批生產后確認清潔效果的方式替代清潔驗證。”但是人家還說“每批后的清潔確認應當根據本附錄的相關要求進行。”清潔確認的要求和清潔驗證有區別么?
       
      你是愿意不寫報告,每批培養基灌裝完了都去做清潔確認,還是愿意做完三批的清潔驗證后,在清潔方法沒有變化的前提下,就不需要再做清潔后的效果監測呢?
       
       

      Feasibility discussion on whether cleaning validation is required for culture medium filling
       
       
      First of all, what we need to confirm is, under what circumstances, clean verification is required. According to the body of GMP: "article 143 cleaning methods shall be verified and verified to be effective in preventing pollution and cross contamination. Cleaning validation should be considered equipment usage, the detergents and disinfectants used, sampling method and location, and the corresponding sampling rate, the nature of the residues and limit, sensitivity factors such as residue method."
       
      Appendix: verification and confirmation article 39 in order to confirm the validity of the cleaning operation rules for equipment directly in contact with the product, cleaning verification shall be carried out. The limits for residues of active substances, detergents and microbial contamination shall be reasonably determined based on the materials involved.
       
      Summarize two regulations, it is for possible contamination and cross-contamination (direct contact with the equipment and products or regions) cleaning method, in order to prove the cleaning method can effectively eliminate possible contamination and cross-contamination, need cleaning method for cleaning validation.
       
      Media fills, the equipment is used and direct contact with the product of the culture medium is may produce pollution to the product, so after media fills the cleaning method is accord with the requirement of the above for cleaning validation, there is no doubt that is the need for validation, if not do, certainly do not conform to the regulations.
       
      So how to do the cleaning verification after the filling of culture media? Because the cleaning verification is aimed at the cleaning process, it can be divided into the following situations:
       
      1. The cleaning method after culture medium filling is consistent with that after product production
       
      In this case, you need to do is in your original cleaning validation scheme, as your products will be medium for analysis, analysis of various kinds of products, such as solubility, toxicity index, and then to determine the target of cleaning validation, choose residue limit and test method. This does not require a separate clean writing scheme for medium filling.
       
      2. The cleaning method after filling media is not consistent with that after production
       
      In this case, you will need to draft the plan separately. The content and requirements of the plan will be the same as those of the clean verification. How to do this is not discussed here, because this is a technical job, and every company has different choices, which will be discussed later.
       
      Some friends will also ask, I only do the culture medium filling twice a year, so how to do the cleaning verification? Can we replace the cleaning verification with the cleaning confirmation? First of all, for those of you who are building a new pharmaceutical factory, you don't have to say that the culture medium is filled three times, and you have enough time and lots to do that.
       
      If you haven't, what about the friends you need to add now? First of all, cleaning verification requires you to do it three times, without specifying how long you need to do it. Three times is a year and a half time, you finish once, write a periodic report not ok? Finish three times and give another report, ok?
       
      Secondly, although article 49 of the appendix states that "for drugs in the development stage or products not frequently produced, the method of confirming the cleaning effect after each batch of production can be used instead of the clean verification." But it was also stated that "each subsequent cleaning confirmation shall be made in accordance with the relevant requirements of this appendix." Is there any difference between the requirement of cleaning confirmation and the requirement of cleaning verification?
       
      You are willing to write a report, every batch of media fills out to do the cleaning validation, or willing to finish three batch of cleaning validation, on the premise of cleaning method does not change, you don't need to do it again after cleaning effect monitoring?
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