stdClass Object
(
    [id] => 16958
    [paper_index] => 202507-02-023057
    [title] => A REVIEW OF THE QUALITY BY DESIGN IN FORMULATION
    [description] => 
    [author] => Mr. Anuj Kumar, Mrs. Deepika Prajapati
    [googlescholar] => 
    [doi] => 
    [year] => 2025
    [month] => July
    [volume] => 10
    [issue] => 7
    [file] => fm/jpanel/upload/2025/July/202507-02-023057.pdf
    [abstract] => This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; product design and understanding including identification of critical material attributes (CMAs); process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. QbD could be a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and method management supported sound science and quality risk management (ICH Q8 QbD suggests that coming up with and developing formulations and manufacturing processes to make sure predefined product quality. 
Product quality is ensured by staple testing, drug substance manufacturing, a fixed drug product manufacturing process, in-process material testing, and end product testing. If they meet the manufacturer’s proposed and FDA approved specifications or other standards like USP for drug substance or excipients, they can be used for the manufacturing of the products.

    [keywords] => Quality, QbD, FDA, Control strategy, Critical quality attributes, Pharmaceutical quality by design, Process understanding, Product understanding
    [doj] => 2025-07-14
    [hit] => 
    [status] => 
    [award_status] => P
    [orderr] => 24
    [journal_id] => 2
    [googlesearch_link] => 
    [edit_on] => 
    [is_status] => 1
    [journalname] => EPRA International Journal of Research & Development (IJRD)
    [short_code] => IJSR
    [eissn] =>  2455-7838 (Online)
    [pissn] => - -
    [home_page_wrapper] => images/products_image/2-n.png
)
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