akash
☆    

India,
2019-08-16 09:43
(1797 d 18:14 ago)

Posting: # 20497
Views: 3,076
 

 Randomization access [GxP / QC / QA]

As per WHO randomization should be accessible to pharmacist and statistician only.
QA dept independent from other. Does it applicable to QA department?


Edit: Category changed; see also this post #1. Please follow the Forum’s Policy[Helmut]
Ohlbe
★★★

France,
2019-08-16 15:28
(1797 d 12:30 ago)

@ akash
Posting: # 20498
Views: 2,453
 

 Randomization access

Dear Akash,

❝ As per WHO randomization should be accessible to pharmacist and statistician only.

❝ QA dept independent from other. Does it applicable to QA department?


In general, access to the randomisation list should be restricted on a "need to know" basis: only those persons who really need the list should have access to it, and only when they need it.

Regarding QA, the person doing an in-process audit of the dispensing of the investigational products should have access to the list for the purpose and for the duration of the audit. This does not mean that all persons within the QA department should have access to the list at all times.

Regards
Ohlbe
UA Flag
Activity
 Admin contact
23,107 posts in 4,858 threads, 1,644 registered users;
52 visitors (0 registered, 52 guests [including 7 identified bots]).
Forum time: 03:58 CEST (Europe/Vienna)

All paid jobs absorb and degrade the mind.    Aristotle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5