Month: March 2023

Restricted access barrier system RABS technology for sterile dosage form manufacturing and filling. Sterile dosage form is required to maintain its sterility and it directly depends on the movement of…

What is 483 USFDA observations? Detail information issued by the US FDAs 483 observation form. US FDA is world one of best pharmaceutical regulatory agency, when it conducts any inspection…

What is OOS in pharma, how to Investigate Out of Speciation results.  OOS is an abbreviation of term “out of specification” the specification means the standards of the quality attributes…

Compressed air gas for pharmaceutical manufacturing it’s limit for microbial count. for sterile product the Total Viable Bacterial count should be lesser or equal to 1 cfu/ cubic metre,  and…

Hold time study in pharmaceutical manufacturing. What is hold time study? Good manufacturing guidelines for pharmaceutical manufacturing mentions that a pharmaceutical manufacturing unit must follow time limitations for stages of…

Hold time study for clean and unclean equipments must be carried out during cleaning validation. It’s one of important aspect that many pharma companies forget to do Hold time study…

Cleaning validation in pharma manufacturing. When you thinking of doing cleaning validation of an equipment or a procedure adapted for cleaning, first question you should ask is that is the…

New Tuberculosis Vaccine which is a subunit vaccine for TB developed that does not require to store at cool cold storage found the problems with live attenuated TB vaccine can…

Recall Classification Mock Recall detail information. Q: Why are Pharmaceutical Product is Recalled by pharmaceutical manufacturing companies? Q: What is the Mock recall? How mush is Time limit set by…