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Quality Assurance

What is Role of Quality Assurance department in Pharmaceutical Industry…??? 

Definition:-

ICH :-

ICH Good Clinical Practice Definition of Quality Assurance. The planned and systematic actions that are established to ensure that the trial is. performed and the data are generated, documented, and recorded in compliance with Good Clinical Practice and applicable regulatory requirements.

 

We will provide you all Information about SOP, SMF, Quality Policy, Quality Management System.

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Quality Control

What is Role of Quality Control department in Pharmaceutical Industry…??? 

Definition:-

 

Quality Control Department is deal with Sampling, Specification & Analytical Procedure preparation & appropriate execution.Quality Control department is also documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory.

We will provide you;

  • Specifications.
  • SOP for Sampling, Testing, Records ( Including test worksheets & Laboratory  notebooks format ), Recording and verifying ;
  • SOP for calibration/qualification of instruments and Maintenance of Equipment also department should maintain Records of the same.
  • SOP of investigation of out of specification and out of Trend results.
  • testing reports and/or certificates of analysis.
  • Data from environmental (air,water & other utilities ) monitoring, where required;
  • validation records of test methods where is applicable.
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Microbiology

What is Role of Microbiology department in Pharmaceutical Industry…???

Microbiology department deal with all type of MLT , Sterility Testing, Environmental Monitoring, Pathogen Testing & Sterilization Activity .

We will provide you all types of Microbiology Testing & Activities Procedure.

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We will provide you all Pharma Solutions Like Pharmaceuticals Guidelines of MHRA, EU, USFDA, ICH, EDQM, EMA,TGA...etc.
All reference of Quality Assurance, Quality Control, Microbiology, Production, Maintenance, Analytical Method Validation Protocol & Reports, MLT Validation Protocol & Report, eCTD, Regulatory Affairs, AHU Validation Protocol& Reports, Reference Validation Protocols.

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