Quality metrics- future need of the pharmaceutical industry for marketing drug products in the U.S. Market

Patel, Krutika and Vasantharaju, SG and Verriboina, Sudheer Kumar and Muddu Krishna, BS (2018) Quality metrics- future need of the pharmaceutical industry for marketing drug products in the U.S. Market. Pharma Times, 50 (8). pp. 15-19. ISSN 0031-6849

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Abstract

Continuous improvement and advancement in Pharmaceutical manufacturing industry are a paramount part of FDA’s mission to safeguard and encourage public wellness. Product recalls are increasing despite elaborate QA/QC monitoring by most companies. Quality metric is the quantification of systems’ effectiveness connected through the manufacturing of drug-based products, including drug-based quality system and are utilized in industry to potentially reduce drug shortages. Quality metrics can incorporate components, for example, consumers’ contentment, suppliers’ execution, manufacturing defects, complaints and other internal as well as external processes. They are difficult to establish but provide excellent insight into the health of the quality system. Quality metric data leads to further development of FDA’s risk-based surveillance schedule and also recognize the conditions that evaluates drug manufacturing and control operations. The objectives of FDA are inspection scheduling based on risk, potential to predict early indicator of drug shortage and advancement in pharmaceutical manufacturing industry. For accomplishing these objectives, FDA initiated voluntary quality metrics reporting program to address regular quality issues in the pharmaceutical industry and allow members to submit information in the underlying period of the program.

Item Type: Article
Uncontrolled Keywords: Quality Metric; FDA; Drug shortages
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Library
Date Deposited: 06 Oct 2018 10:12
Last Modified: 06 Oct 2018 10:12
URI: http://eprints.manipal.edu/id/eprint/152103

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