什么叫合乎 GMP 的机械设备设计？
什么叫合乎 GMP 的机械设备设计？It's a frequent question whatGMP-compliant equipment design is or how a system has to be made up inorder to be GMP compliant and suitable for the manufacturing of medicinalproducts/APIs.它是1个疑难问题，什么叫合乎 GMP 的机械设备设计？或是1个系统软件怎样搭建能够合乎 GMP规范并合适药物/API生产制造？The short answer is: thesystem has to be qualifiable.简而答之：系统软件务必是可确定的。Since this requires someclarification, here comes a more elaborate answer. To be clear from the start,though, there is no regulatory document or general GMP certification forequipment. This is simply impossible as pharmaceutical manufacturing processesare quite different: dry granulation, tableting, fermentation, sterile fillingand others, for example. And if you add manufacturing processes of the classic(chemical) API production, there are clearly more. Even the product itself canpose various requirements for the production equipment. It makes a bigdifference for the design of a system whether or not the manufactured producthas to be sterile or whether the product is temperature or oxygen sensitive.This certainly has an impact on the system design as well. But even thoughthese requirements are quite diverse, there are some general specificationsthat apply to every GMP compliant equipment design in the GMP regulations:这儿得出1个更详尽的参考答案开展表明。有关机器设备，并沒有对于的管控文档或通用性的GMP 验证。这真是是并不是的，由于不一样药物生产工艺流程彻底不一样：比如，干法纪粒、压片、发醇、无菌检测罐装等。假如加上(有机化学)API 的生产工艺流程，显而易见也有大量。乃至商品自身也会对生产线设备明确提出各种各样规定。它系统对的设计构思有挺大的危害，包含生产制造的商品是不是无菌检测，商品是不是对溫度或co2比较敏感等。这或许也系统对设计构思有危害。可是，虽然这种规定十分多种多样，但在 GMP政策法规中每一合乎 GMP 规范的机械设备设计中，仍有某些通用性规范:The system may not have a negative impact on product quality 该系统软件不可对产品品质造成不良影响The system must be easy to clean系统软件务必便于清理The system has to comply with applicable technical rules 系统软件务必遵照适度的技术标准The system must be suitable for its purpose系统软件务必合乎其主要用途These four points are still sovague that further explanation is in order.这几点依然模棱两可，必须深化表述。The system maynot influence the product quality in a negative way.系统软件不可对产品品质造成不良影响。This simply means that theremay no negative interaction between product-co