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NIHFW NIHFW

GMP of Parenteral and Sterile preparation

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GMP of Parenteral and Sterile preparation

About the Course

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  • GMP of Parenteral and Sterile preparation

    Introduction to GMP and Regulatory Guidelines

    Facility Design and Layout for GMP

    Documentation and Record Keeping

    Stability Studies

    Non Compliances Observed in Parenteral and Sterile Preparation

    Process Validation

    Media fill Validation

    Recent Advancements in Analytical Instrumentation Techniques

    Validation of Lyophilizer

    CIP SIP of Simple and Complex Injections

    Pharmaceutical water system and qualification

    Concepts of OOS, Deviation

    Primary Packaging Material for parenteral and Sterile preparations

    HVAC System for parenteral & Sterile Prepration

    Planning Conducting inspections based on risk based approach

    Validation of Sterilization process

  • Post Assessment

    Assessment

  • Certificate

    CDSCO Certificate

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This course includes

  • PDF
  • Assessment
  • Certificate

For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225
Email - drdkyadav@nihfw.org

Assistant Nodal Officer, SAKSHAM
Dr. Raj Narayan
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 327
Email - raj@nihfw.org

Address

Department of Statistics & Demography (S&D) NIHFW, H52G+C6X, Baba Gang Nath Marg, Block A, Munirka, New Delhi, Delhi 110067
Website : www.nihfw.org