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Dose audit, Advantages of Automation, Sterility Audit, Classification of…
Dose audit
IF DOSE EDIT FAIL
Complete investigation to be perfomed
Verfify that there is no change in raw material, environment or manifacturing processes.
cross check if contamination is not from laboratory
Contamination can occur during testing specially if process is complecated. so take sample before those processes.
Cross-check if correct bioburdon calculation is right
Verify that correct Sample Item Portion (SIP) was tested and properly packeged.
Cross-chek if correct verification dose was calculated
Compare bioburdon count of initial validation and auditing and if there is increase in bioburden then change the sterility dose.
Increase bioburdon count may be due to radiation resistant microorganisms. fix the problem.
Verify tht packages is not comporomised
flucatuation is bioburdon indicates lack of manifcatoring process control. so manifacturer should investigate facilities envoronment control.
check valve that separates sterile and non sterile area
check dead lags
Identify any valve that does not recive steam
check slopes
Check low points that are undrained
Identifly single steam trap that are not working
Identify if vaccume is created during sterilization and avoid vaccume and fix the problem.
Bioburdon (initial) tesitng
Sterility testing
Advantages of Automation
increase products
high predictiblity of quality
highly consistant process
highly consistant output
reduce labor cost
Sterility Audit
Environmental Montroing Testing
Bioburden Testing
Verification Dose Experiment
Classification of Audit reports
Acceptable
No critical findings and fewer correctable major findings that can be corrected withing 30 days
Unacceptable
Critical findings or many major findings. Pose risk if not corrected
Conditional
No critical findings and few correctable findings that need to be corrected but temperory control is required
Disadvantages of Automation
No common sense / high valnurablity
Excessive cost
High initial cost (can be componsated in long run though)