Validation Review Board - Industry Standards for Validation Teams

D

deethreepio

#1
I am working on establishing a validation team with oversight from senior management. Does anyone have suggestions for finding what industry standards are for validation teams who would initially be responsible for carrying out validations but would eventually transition to monitoring upcoming projects and creating IQ/OQ/PQ templates for the company?

Thank you
 
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Jeff Frost

#2
You should obtain ISO/TS 14969 which is the guidance document for ISO 13485, it contains useful information on validations. Also obtain Global Harmonization Task Force document # GHTF/SG3/N99-10, Quality Management Systems – Process Validation Guidance. I believe a copy is in the Elsmar Cove attachment file (top of web page) or just Google the document number and find a copy.
 
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D

deethreepio

#3
Thank you for this. I hadn't considered ISO/TS 14969. However, I am more interested in specifics of people's experience in developing those teams in regards to time commitment and organization.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Typically R&D and manufacturing engineering / technical staff + a QA engineer or two (preferably one who's also into RA).

Edit: You'd want someone with strong statistics background (at least 1).
 
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