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    Tag: Quality Assurance

    SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)

    Note: The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is therefore, needed in the design, maintenance and…

    pharmastateacademy-2
    PharmaState Academy 29/05/2018
    5 Comments

    SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES & LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS

    Sterile products are very critical and sensitive in nature need very high degree of precautions, prevention and preparations and needed. Dampness, dirt and darkness are…

    pharmastateacademy-2
    PharmaState Academy 29/05/2018
    4 Comments

    GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS

    **To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference;…

    pharmastateacademy-2
    PharmaState Academy 29/05/2018
    4 Comments

    TYPES OF AIRLOCKS USED IN PHARMA

    There are three basic classifications of airlocks that are physically the same, but only the pressure cascade regime differs. Cascade Airlock:- These airlock are very…

    pharmastateacademy-2
    PharmaState Academy 12/05/2018
    0 Comments

    BOOKS & STANDARDS FOR PHARMACEUTICAL INDUSTRY

      HVAC DESIGN ASHRAE 62.1 Ventilation for ACC – Acceptable Indoor Air Quality ASHRAE 189 Standard for the Design of High-Performance Green Buildings ASHRAE 90.1…

    pharmastateacademy-2
    PharmaState Academy 03/05/2018
    0 Comments

    DETERMINING THE EFFECTIVENESS OF THE AUTOCLAVE PROCESS

    A number of tools are available to assess the performance of the autoclave; these include physical, chemical and biological indicators. It is important to note…

    pharmastateacademy-2
    PharmaState Academy 03/05/2018
    0 Comments

    GUIDELINE ON GOOD MANUFACTURING PRACTICES (GMP) IN PHARMA

      GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced…

    pharmastateacademy-2
    PharmaState Academy 23/01/2018
    0 Comments

    AN OVERVIEW ON SIX SIGMA

    Definition of Six Sigma:- Six Sigma is a smarter way to manage business or department. It is a vision of quality that equates with only…

    pharmastateacademy-2
    PharmaState Academy 18/01/2018
    0 Comments

    MEDICINE LICENSING PROCESS IN UK (MHRA)

      A licence, also referred to as a marketing authorization, from the MHRA is required before any medicine can be used to treat people in…

    pharmastateacademy-2
    PharmaState Academy 18/01/2018
    0 Comments

    FILTER INSTALLATION LEAK TESTS – TOTAL AEROSOL PENETRATION TEST METHOD FOR CLEAN ROOMS

    The purpose of the total aerosol penetration test method is to verify filter and installation integrity when downstream access to the filter and installation is…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
    0 Comments
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