• Login
    • Library Home
    View Item 
    •   BracU IR
    • Department of Pharmacy (PHR)
    • Bachelor of Pharmacy
    • Project report (Bachelor of Pharmacy)
    • View Item
    •   BracU IR
    • Department of Pharmacy (PHR)
    • Bachelor of Pharmacy
    • Project report (Bachelor of Pharmacy)
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    An overview of established practices and parameters to ensure quality of a pharmaceutical product

    Thumbnail
    View/Open
    ID 12346007_PHR.pdf (1.119Mb)
    Date
    2017-10-07
    Publisher
    BRAC University
    Author
    Akter, Shimu
    Metadata
    Show full item record
    URI
    http://hdl.handle.net/10361/9486
    Abstract
    The quality of a pharmaceutical product is one of the most challenging considerations of the pharmaceutical industry because it is directly related to the patient health and safety. Every pharmaceutical product should be manufactured by a licensed pharmaceutical manufacturer according to the guidelines, which should be stringently monitored by the licensed pharmacist, in order to attain the target quality product. The guidelines that are followed in the pharmaceutical industry are several, such as the ICH guideline, WHO guideline, FDA guideline, etc. A systematic approach needs to be designed and developed with the ‘end’ in mind, in order to ensure quality where the product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches. The impact of starting raw materials and process parameters on product quality must surely be well understood, with an emphasis on product and process understanding and process control. All processes involved must be continually monitored, evaluated, documented and updated in line with the ‘quality by design’ approach to allow for consistent quality throughout product life cycle. The aim of the study was to highlight the various approaches and steps involved, and other relevant considerations that a pharmaceutical company must undertake, whether manufactured in-house or by outsourcing, in order to ensure product quality through ‘quality by design’ approach.
    Keywords
    Pharmaceutical product; Quality Product; Quality Control
     
    Description
    This project report is submitted in partial fulfilment of the requirements for the degree of Bachelor of Pharmacy, 2017
     
    Cataloged from PDF version of project report.
     
    Includes bibliographical references (page 84-86).
    Department
    Department of Pharmacy, BRAC University
    Collections
    • Project report (Bachelor of Pharmacy)

    Copyright © 2008-2019 Ayesha Abed Library, Brac University 
    Contact Us | Send Feedback
     

     

    Policy Guidelines

    • BracU Policy
    • Publisher Policy

    Browse

    All of BracU Institutional RepositoryCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    View Usage Statistics

    Copyright © 2008-2019 Ayesha Abed Library, Brac University 
    Contact Us | Send Feedback