1. What is 21 CFR part ?
Title 21 CFR Part of the Code of Federal Regulations deals with the Food and Drug Administration (FDA)
2. Different between Qualification and Validation?
“Qualification” refers to the activities performed on facility, utility and equipment
The “Validation” refers to the activities performed on processes, practices and methods.
3. Critical utilities in Injectable facility
Air Handling System
Pure steam Generation and Distribution System
Purified Water Generation and Distribution System
Water for injection Generation and Distribution system
Compressed air
Nitrogen
4.What is dead leg?
A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.
6. What is the recommended bio burden limits of purified water & WFI?
Purified water has a recommended bioburden limit of 100 CFU/mL,
Water for injection (WFI) has a recommended bio burden limit of 10 CFU/100 mL.
7.How many Phases of water system Qualification?
Qualification of pharmaceutical water system involves three phases
Phase -1
Phase -2
Phase -3
8. What needs to be checked during AHU validation?
During AHU validation, following tests shall be carried out
Filter efficiency test,
Air velocity & number of air changes,
Air flow pattern (visualization)
Differential pressure, temperature and RH
Static condition area qualification
Dynamic condition qualification
Non-viable count
Microbial monitoring
Area recovery and power failure study.
9.Which ISO guideline demonstrate compliance of HVAC system
ISO 14644-1 and 14644-3
10. Guidelines for pipeline installed in Pharmaceutical water system.
ASME/ASME BP
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