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    Category: SOPs

    Important SOPs for Quality Control Department (Chemical section) in Pharmaceutical Industry

    Sampling of raw material, packaging material, bulk, intermediate and finished product Raw material, packaging material, bulk, intermediate and finished product analysis Cleaning and storage of…

    pharmastateacademy-2
    PharmaState Academy 04/09/2018
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    SOP on Data Integrity in Pharmaceutical Industry

    Objective: To lay down a procedure for data integrity as part of quality management system. Scope: This procedure is applicable for all the data associated…

    pharmastateacademy-2
    PharmaState Academy 31/08/2018
    1 Comment

    Important SOPs for Quality Assurance in Pharmaceutical Industry

    Preparation, review, approval and control of SOPs Training procedure Handling and control of documents Change control Handling of deviations SOP for line clearance Handling of…

    pharmastateacademy-2
    PharmaState Academy 28/08/2018
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    Procedure for Cleaning and Monitoring of Clean Room Pass Boxes

      Cleaning of Clean- Room Pass Boxes: (A) Subject:  Procedure for Cleaning of Class- Room Pass Boxes. (B) Purpose: This procedure is applicable for Cleaning of Clean-…

    pharmastateacademy-2
    PharmaState Academy 26/06/2018
    1 Comment

    Working Principles for Dynamic and Static Pass Boxes

    (1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box. (A) Objective:  This working principle is applicable for usage of Dynamic Pass Box in formulation…

    pharmastateacademy-2
    PharmaState Academy 26/06/2018
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    Validation of Clean Room Pass Boxes

    (A) Clean Room: A Clean Room is an area in which the quantity and size of air- borne particles are controlled in order to limit contamination.…

    pharmastateacademy-2
    PharmaState Academy 22/06/2018
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    Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA

    Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances                          CATEGORY                             TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical…

    pharmastateacademy-2
    PharmaState Academy 15/06/2018
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    Pharma Regulations and Guidelines-India, Easy Access Links

    (1). Regulations & Guidelines:              CDSCO    Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of…

    pharmastateacademy-2
    PharmaState Academy 15/06/2018
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    Specimen Collection, Transport and Processing: Bacteriology

    F. Pus Purpose: To isolate and identify bacterial etiological agent(s) in deep-seated pus/wound specimens. Specimen collection: Preferably collect specimen prior to initiation of therapy and only…

    pharmastateacademy-2
    PharmaState Academy 01/06/2018
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    Standard Operating Procedures (SOPs)- Bacteriology

    General Guidelines Introduction: This is a comprehensive standard operative procedure manual for all types of specimens received in a clinical bacteriology diagnostic laboratory serving a…

    pharmastateacademy-2
    PharmaState Academy 27/05/2018
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