For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, for example, live organisms and…
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#21 CFR 11#483#Aseptic Processing Isolator#biotech#CDSCO#cGMP#CPMS#FDA#GMP certificate#Injectable#ISO14644#Isolator#MHRA#NVPC#Palash#Palash chandra Das#Palash Das#Parenteral#Particle#Particle Count#Pharma#PRES#QRM#Qualification#Risk#Schedule M#Steam sterilizer#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#Validation#warning letter#WHO
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
read moreFor companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can…
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