Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System

Month: March 2023

  • Restricted access barrier system

    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 personnel working in the aseptic filling area. Slightest movement of personnel can shed a huge number of particles in the filling area and there will…

  • What is 483 observation of USFDA

    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 of best pharmaceutical regulatory agency, when it conducts any inspection and observe any discrepancy or violation with respect to the good manufacturing practices guidelines issued by US FDA, it provides the observations in a format…

  • 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 specification” the specification means the standards of the quality attributes like assay, measure of content in the formulation, Colour standard, written visual description, identification, and purity etc. When a product or a material falls out…

  • Compressed air gas for pharmaceutical use

    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 be lesser or equal to 1 cfu/ cubic metre,  and Total fungal count should be nil or not detected, the particle count of compressed air should equal to the at rest condition of the respective…

  • 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 pharmaceutical manufacturing unit must follow time limitations for stages of manufacturing. US FDA guidelines have not provided a particular time as standard for hold time. Definition of hold time: It is a time period for…

  • Hold time study in cleaning validation

    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 for clean and unclean equipments during Cleaning Validation. What is Clean equipment hold time dirty equipment hold time ? During validation of cleaning procedures, hold…

  • Cleaning Validation In Pharma

    Cleaning Validation In Pharma

    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 cleaning validation planed in the validation master plan? If not it’s not late to do that. Along with cleaning validation most important work needs to…

  • New Tuberculosis Vaccine developed that does not require to store at cool storage

    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 be eliminated with this new vaccine. Tuberculosis vaccine consist of live bacteria, mycobacterium bovis, its virulence is reduced by the process of attenuation, vaccine is…

  • Recall Classification Mock Recall

    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 FDA for recall? Classification of Recall in pharmaceutical. Give procedure for doing mock recall. Q: What is type1, 2,3 recall or What is Class A,B,C…

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