一期临床样品的BPR

NzrKA2I03g

一期临床样品的制备必须需要BPR吗？
车间还是研发起草，复核呢？

window

尚未交付正式生产的，需要有制备记录即好，至于该哪个部门起草复核，按你公司相关职责确定即可

四叶花

有行动就应该有记录

zysx01234

制备记录？其实规范的企业，对研发记录也是有要求的。就看企业怎么管理了。

beiwei5du

一般的临床一期如果在合乎条件的实验室做，则由研发人员制定，如果是在车间，还是车间制定好！
E.  Manufacturing and Records

The manufacture of phase 1 investigational drugs should follow written manufacturing and
process control procedures that  provide for the following records.
A record of manufacturing data  that details the materials,  equipment, procedures used,
and any problems encountered during manufacturing.  We recommend that
manufacturers retain records sufficient to replicate the manufacturing process.  Similarly,
if the manufacture of a phase 1 investigational drug batch is initiated but not completed,
we recommend that the record include an explanation of why manufacturing was
terminated.  
A record of changes in procedures and processes used for subsequent batches along with
the rationale for any changes
A record of the microbiological controls that  have been implemented (including written
procedures) for the production of sterile-pro cessed phase 1 investigational drugs that are
covered by this guidance.  You should follo w the recommendations for use of aseptic
techniques and the control of in-process materials, components, and container closures
designed to prevent microbial and endotoxin contamination (see section VI.C).  

9

小金库

谢谢分享。