Restricted access barrier system
Restricted access barrier system RABS technology for sterile dosage form manufacturing and filling. Sterile dosage form is required to maintain…
What is 483 observation of USFDA
What is 483 USFDA observations? Detail information issued by the US FDAs 483 observation form. US FDA is world one…
How to Investigate Out of Speciation results
What is OOS in pharma, how to Investigate Out of Speciation results. OOS is an abbreviation of term “out of…
Compressed air gas for pharmaceutical use
Compressed air gas for pharmaceutical manufacturing it’s limit for microbial count. for sterile product the Total Viable Bacterial count should…
Hold time study in pharmaceutical manufacturing
Hold time study in pharmaceutical manufacturing. What is hold time study? Good manufacturing guidelines for pharmaceutical manufacturing mentions that a…