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cGMP

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Quality Agreement Technical (Contract Manufacturing)

  • Post author:pharmabeginers
  • Post published:July 7, 2022
  • Post category:Audit/cGMP/QA Sop/QC Sop/SOPs
  • Post comments:0 Comments

Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject…

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Depyrogenating Tunnel – Qualification Protocol (PQ)

  • Post author:pharmabeginers
  • Post published:March 25, 2022
  • Post category:cGMP/Protocol/Validation
  • Post comments:1 Comment

Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0   Objective: The purpose of this protocol is to provide…

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Reference Standard, Working Standard Handling

  • Post author:pharmabeginers
  • Post published:February 12, 2022
  • Post category:cGMP
  • Post comments:0 Comments

Procedure for Management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard. Working Standard / Reference Standard Management 1.0   Objective : To lay down procedure…

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