#PharmaGyan How are equipment qualified in pharmaceutical industry? EQUIPMENT QUALIFICATION,IQ,OQ,PQ,VALIDATION
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IQ OQ PQ are 3 pillars of Process Validation. IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance Qualification. Before you even get to IQ, OQ, PQ, if you're acquiring a new piece of equipment, you'll need design specifications that define exactly what's in that piece of equipment
Equipment Qualification (urs,dq,fat,sat,iq,oq,pq)
URS - USER REQUIREMENT SPECIFICATION
DQ - DESIGN QUALIFICATION
FAT - FACTORY ASSESSMENT TEST
SAT - SITE ACCEPATANCE TEST
IQ - INSTALLATION QUALIFICATION
OQ - OPERATIONAL QUALIFICATION
PQ - PROCESS QUALIFICATION
This video covers in details:
- What is required in IQ, OQ & PQ.
- FDA guidelines on IQ OQ PQ as per 21CFR 820.75 and as per ISO13845
- Why do we to validate a process?
- IQ OQ PQ process Flow
- Input/ Output of each IQ OQ PQ
QUALIFICATION, URS, DQ, FAT, SAT, IQ, OQ, PQ IN PHARMA
How are equipment qualified in pharmaceutical industry? EQUIPMENT QUALIFICATION,IQ,OQ,PQ,VALIDATION
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