breifely explain about media fill stimulation
A media fill is the performance of an aseptic manufacturing and filling procedure using a sterile microbiological growth medium(i.e. SCDM), in place of the drug, to test whether the aseptic procedures,equipements,personnel,system are adequate to prevent contamination during actual drug production.
Yes , I agree with you Sir
thank you very much sir. for giving valuable information. i am working in microbiology department sir but i got an opportunity in qa so i hv an interview so kindly provide some impotent interviewed questions for me, please.
Pls prepare following topic
Line clearance procedure,in process checks,GDP.
area validation, validation of equipment like autoclave,vial washing machine,tunnel.
environmental monitoring,settle plate method and active air sampling.
change control, incident ,deviation
D value ,z value ,F0 value definition
Media fill validation.
breif description of equipment used in plant (make,model)
Area classification (eu-gmp guideline, iso guideline)
search on google https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf
download it and read it.
thank u sir
What are the possible and challenge studies/ should be done, required during media fill study?
Studies required should be specified in the process risk assessment.