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

Krutika Patel, S. G. Vasantharaju, Sudheer Kumar Verriboina, B. S. Muddu Krishna

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)15-19
Number of pages5
JournalPharma Times
Volume50
Issue number8
Publication statusPublished - 01-08-2018

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics(all)

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