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RegisterRequired SOPs for BA BE unit by the WHO [GxP / QC / QA]
posted by Helmut 
– Vienna, Austria, 2006-11-13 12:27 (6758 d 03:47 ago) – Posting: # 363
Views: 13,372
Hi Dr. Pravin!
A good start is Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies) of the Fortieth Report (WHO Technical Report Series No. 937)'.
I don't know of any countries specific regualtions...
Do you mean the first SOP (the one which describes how to write SOPs)?
In the German language we have a nickname for this SOP, namely 'Ursuppe', which means 'primordial soup'
This SOP should describe the managagement of all SOPs (preferably you should prepare a template for your word processor), including all necessities suitable for your organization (title page, signatures, dates for coming into operation, written by, approved by, replaces version no., changes from last version, revision and filing procedures,...)
❝ can you provide me the information regarding the SOP required for BA BE unit by all regulations.
A good start is Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies) of the Fortieth Report (WHO Technical Report Series No. 937)'.
I don't know of any countries specific regualtions...
❝ ...and standard design of the [...] SOP for SOP.
Do you mean the first SOP (the one which describes how to write SOPs)?
In the German language we have a nickname for this SOP, namely 'Ursuppe', which means 'primordial soup'
This SOP should describe the managagement of all SOPs (preferably you should prepare a template for your word processor), including all necessities suitable for your organization (title page, signatures, dates for coming into operation, written by, approved by, replaces version no., changes from last version, revision and filing procedures,...)
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Helmut Schütz
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Complete thread:
- Required SOPs for BA BE unit by all regulatory requirement Dr.Pravin 2006-11-13 06:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Required SOPs for BA BE unit by the WHOHelmut 2006-11-13 11:27
- Required SOPs for BA BE unit by the WHO sekhar91 2006-11-22 12:44
- Required SOPs for BA BE unit by the FDA? Helmut 2006-11-22 13:06
- Required SOPs for BA BE unit by the WHO sekhar91 2006-11-22 12:44
- Required SOPs for BA BE unit by the WHO sekhar91 2006-12-22 11:04
- Required SOPs for BA BE unit by the FDA? Helmut 2006-12-22 12:30
- Required SOPs Clinical Trials! Sumanta Goswami 2007-01-16 17:25
- Required SOPs Clinical Trials! venu 2007-02-16 08:04
- Required SOPs Clinical Trials! Sumanta Goswami 2007-01-16 17:25
- Required SOPs for BA BE unit by the FDA? Helmut 2006-12-22 12:30
- Required SOPs for BA BE unit by the WHOHelmut 2006-11-13 11:27
Ing. Helmut Schütz