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One of the basic expectations of Quality Management System is to carry out Self Inspection to assess the level of compliance. Carrying out Self Inspection is mandated by almost all the regulators in the world be it USFDA, EU,…
Every pharmaceutical manufacturer sometimes goes berserk about ever changing regulations and multiple interpretations of the same guideline by various GMP experts. One of the grey areas is storage of reference and retention samples. This becomes an area of big concern…
Why Media Fill? During manufacturing of sterile formulations viz. Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), Vaccines and other similar formulations, it is important to ensure that the manufacturing process itself is aseptic. Additionally, it provides another level of…