Release for Commercial Use of Drug Product Validation Batches

beiwei5du

Summary - Release for Commercial Use of Drug Product Validation Batches（pre-validation batches/revalidation with significant planned change)
选自：http://www.gmpsop.com
Batches of product manufactured prior to completion of PV activities may be released for commercial use following verification of acceptable results for all tests, verification that the acceptance criteria have been satisfied, the critical process parameters, ranges and materials used are the same as the proposed commercial manufacturing process and fulfilment of other site requirements for product release as necessary. Release for commercial use will require satisfactory completion of the validation study for that process, ensuring that the recommendations described in this bulletin are met for these pre-validation batches.

Product batches manufactured prior to completion of PV activities may include Demonstration (demo) batches, sometimes called ‘proof of concept’ batches, pre-validation
batches, or engineering batches. These are typically manufactured for the purpose of examining a new process or a process with a significant planned change that requires
revalidation, to insure that the process operations are understood and work as planned before beginning production of validation batches.

The process used must be within processing conditions allowed by the approved product registration, unless the validation activities include, or are as a direct result of changes to registered processing conditions. The requirements for Product Change Management system should be followed. Once registration approval has been received, the recommendations of this guidance can apply to the new manufacturing process.

The scope of a validation project can vary in many ways. The decision to approve and release product batches prepared for the validation study should be made only after review of relevant data and verification that the required acceptance criteria have been met. Depending on organization of validation protocol(s) prepared for a process, there may be different points in the production process where evaluation of data and verification of meeting acceptance criteria are needed.


这边有个疑问，对于和工艺验证方法的工艺完全一致的，并且在验证批以前开展的demonstration（demo) batches（完全按照GMP的要求，新公司，但还没有取得GMP证书），那么对于这种批次的产品，上面文章也有提及在某些情况下可以放行（比如在完成PV并通过后等等），大家有实践过这种操作么？？？？？

albertchen

谢谢分享啊

piao0923

这种情况很多啊，就是验证批产品的放行规定。

beiwei5du

piao0923 发表于 2015-11-22 16:55
这种情况很多啊，就是验证批产品的放行规定。

验证前的pilot batch呢？？如果完全按照GMP，且和工艺验证工艺完全一致！

syhorchid

看看再说

胜利者

谢谢分享

Jason

国外原料药的验证批是不能销售的，但是国内，好像可以只要该合格的合格，偏差都关掉。一般在放大批3批，工程批3批（或工艺确认批），然后验证批3批，之后才是大量生产批，一般是9批后才做commercial batch。

lumang

这是哪个机构发布的guidance?,验证批应该是没有批文的吧，怎么能够放行？在我国，必须有生产许可证、注册证、GMP证后，药品才能上市销售。

beiwei5du

lumang 发表于 2015-11-23 09:24
这是哪个机构发布的guidance?,验证批应该是没有批文的吧，怎么能够放行？在我国，必须有生产许可证、注册证 ...

来自一个网站，验证批次在拿到所有生产许可证、注册证、GMP证后，也能销售作为商业化生产？

Jason

lumang 发表于 2015-11-23 09:24
这是哪个机构发布的guidance?,验证批应该是没有批文的吧，怎么能够放行？在我国，必须有生产许可证、注册证 ...

是的，但是CRO帮厂家做的第三方生产的药品，是来做临床的，这算不算是销售呢？国内的各省有不同的规定，有些省的官员说可以，有些省的官员说不可以。好像国内没有guidance的文件规定！

cgc717

没有取得GMP证书之前生产的，进行销售，在国内是否违法（指在现场认证检查之前生产的）？

cgc717

piao0923 发表于 2015-11-22 16:55
这种情况很多啊，就是验证批产品的放行规定。

这个应该是指有生产许可及GMP证书的条件下才可以吧？！