Pharmaceutical Resource and Education Services ( PRES) is committed to provide a quality training and education services. All the content in this channel is free of cost. Its a novel mission carried out by PRES to educate the entire pharmaceutical and health care professional. Knowledge is the key of success and empower you to grow in your career.
Channel Maintain by : Palash Chandra Das , SME in sterile operation & practices (M.Pharm) Mail id: mail2uscgmp@gmail.com, LinkedIn : www.linkedin.com/in/palashchandradas/
FAQ: 1. Why we are different from other ? We directly discuss about actual regulatory requirements through technical article, guidance or regulations. We help to understand better the cGMP requirements. 2. Can we include this video for institutional or organization training ? Yes, you can utilize this educational video to your students or employees.
Sir kindly do the video on 1)actual practical basis disinfectant validation, process flow 2)actual microbial OOS flow. 3) trend analysis as per contamination recovery rate and incident rate... It will help a lot to people like me...
Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor Change in equipment Change in area Change in location / site Introducing new product Change in batch size Change in software
Sir, will you please answer my below question. Why ampoule products require sterilization and vial products for depyrogenation. Can we use depyrogenation tunnel for ampoule product
Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance? 8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser. Load dryness should be confirmed by visual inspection as a part of the sterilisation process acceptance.
There is one more possibility of introducing H2O2 by turbulent flow through nozzle directly to the chamber, in IMA machine we had qualified.For your information
