疫苗工艺，就像制作蛋糕一样
ISPE最近发布一篇文章，表示生产疫苗的工艺就像制作蛋糕一样，需要遵循非常具体的配方和工艺。
疫苗原料药
The Drug Substance batch manufacture has to be tightly controlled and is fully documented against an approved and proven process which can be repeated over and over to make large quantities of Drug Substance. This is referred to as a validated process. Various analytical tests are carried out on samples of this batch as part of Quality Control. There are lots of documents that trace every part of the process, such as where we get the ingredients for each part of the manufacture, how we manufacture, how long we take to do each step in the manufacture, what temperatures and other conditions are used to make the batch, what tests we do on the finished batch, etc. All of these documents form the batch records.
疫苗原料药批生产必须受到严格控制，并针对已批准和已验证的工艺进行完整记录，按照该工艺可以反复进行、以生产大量药品。作为质量控制的一部分，需要对批次样品进行了各种分析检验。有很多文档可追踪工艺的每个部分，例如我们在哪里获得生产疫苗的成分、我们的生产方式、生产每个步骤花费的时间、使用的温度和其它条件，对成品批次进行什么检验等。所有这些文档在一起，构成批记录。
The Drug Substance batch records and Quality Control records showing that the batch has been made correctly and to specification are then independently reviewed by an independent group called Quality Assurance whose role is to do just that, assure Quality.
原料药批记录和质量控制记录显示已正确生产了该批次，并符合规格要求，然后由QA对其进行独立审查，该小组的职责是确保质量。
制剂
Once all of these Drug Substance stages of the process are completed satisfactorily, the Drug Substance may be formulated further and filtered to get the vaccine to the final formulation. It will then be filled into much more useful containers, (elastomer stoppered vials) or devices (pre-filled syringes) to be used in the clinic for delivery to patients. In the pandemic, this is likely to be in vials (a small bottle) containing approximately 5-10 doses currently. (Each vaccine specifies how many doses are in each vial.) The process to fill the Drug Product into smaller containers is again a tightly controlled process, completed in clean rooms, often in further contained spaces to avoid any contamination. This is generically called Fill and Finish. At this point, the contained product is now called a Drug Product. From here on, it gets labeled and packaged for transport.
一旦原料药所有工艺阶段均成功地完成，就可以进一步配制药物并过滤，以使疫苗达到最终制剂的水平。然后将其装入容器（弹性塞瓶）或器械（预装注射器）中，以便在诊所中使用，为患者接种。在大流行中，这很可能是装在西林瓶（一种小瓶）中，目前包含约5-10剂。（每种疫苗规定每个小瓶中有多少剂量。）将药品灌装到较小容器中，这一工艺是严格控制的，在洁净室中完成，通常在更密闭的空间中进行，以避免任何污染。这通常称为灌装和完成（Fill and Finish.）。此时，所包含的产品现在称为药品制剂。从这里开始，它被贴上标签并包装好以进行运输。
包装
The filled containers are labeled for full traceability and then these are put into labeled boxes with product information leaflets for use at the clinic. The individual boxes are then put into larger storage boxes. Again, the process is completed to very detailed procedures and these are all documented. Most of the pictures on the News are of this Fill and Finish part of manufacturing.
灌装后容器标签上应确保可追溯性，然后将它们放入带有说明书的小盒中，以供诊所使用。然后将小盒放入更大的存储外箱中。同样，该工艺按照非常详细的步骤完成，并且需要进行书面化记录。疫苗新闻中的大多数图片都属于生产的“填充和完成”部分。
Ref.:Guide to the Process of Fill and Finish and Vaccine Release.02 February, 2021. ISPE
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