Journal: Drug Invention Today

Article Id: JPRS-P'ceu-00004954
Title: Product quality review on pharmaceutical dosage forms
Category: Pharmaceutics
Section: Review Article
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  • Abstract

    The product quality review (PQR) is basically an annual review to determine whether there are potential improvements in the pharmaceutical product’s system or production or improvements to the product requirements and manufacturing processes. The PQR is an assessment designed to satisfy the requirements of various good manufacturing (cGMP) regulatory bodies. A good manufacturing practice ensures that goods are reliably manufactured and regulate in compliance with quality standards. It is intended to mitigate drug errors and also she risks associated with pharmaceutical product manufacturing. This article gives information regarding the contents of the PQR and documentation process. It also centers on the United States and European Union legislation and regulatory standards with comparative estimation of resemblances and variances of circumstances related with the drug product manufacturing in these two countries. The article also gives information regarding the trend analysis and the types of trends that can be plotted using statistical tool which is used in pharmaceutical industry.

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    Author(s) Name:

    Teja Sri Maddirala, T. Shailesh*, S. Hemanth Kumar, M. P. Gowrav, H. V. Gangadharappa

    Affiliation(s) Name:

    Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India

    *Corresponding author: T. Shailesh, Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru - 570 015, Karnataka, India.

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    Author:

    Teja Sri Maddirala, T. Shailesh*, S. Hemanth Kumar, M. P. Gowrav, H. V. Gangadharappa

    Title:Product quality review on pharmaceutical dosage forms
    Journal:Drug Invention Today
    Vol(issue):13 (April )
    Year:2020
    Page No: (558-562)
  • Experimental Methods Keywords

    Methodology:Current good manufacturing practice, Good manufacturing practice, Product quality review
    Research Materials:pharmaceutical dosage forms

Keywords

Current good manufacturing practice Good manufacturing practice Product quality review

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