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Quality Manual & Quality Policy in Pharmaceuticals

  • Post author:pharmabeginers
  • Post published:September 28, 2023
  • Post category:cGMP
  • Post comments:0 Comments

WFIWhat is a Quality Manual (Quality System Manual / QMS Manual? A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems.…

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Dry Heat Sterilizer (DHS) Validation Protocol

  • Post author:pharmabeginers
  • Post published:August 10, 2023
  • Post category:cGMP
  • Post comments:1 Comment

oProcedure and protocol for Dry heat sterilizer (DHS) validation, DHS consists of accurately measuring the temp. at critical points within the sterilization chamber throughout the process. Dry heat process generally…

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MLT Method Validation Procedure & Protocol

  • Post author:pharmabeginers
  • Post published:June 29, 2023
  • Post category:cGMP/GLP/Micro Sop/Microbiology/Quality Control/SOPs/Validation
  • Post comments:0 Comments

The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory…

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