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The GMP Insider

The GMP Insider

De : Tushar Arora
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GMP Insider is your go-to podcast for practical insights into pharmaceutical quality, Good Manufacturing Practices (GMP), and regulatory compliance.

Designed for quality professionals, manufacturing teams, and pharma leaders, this show breaks down complex regulations into clear, real-world guidance. Each episode explores topics like audits, CAPA, data integrity, quality systems, validation, and global regulatory expectations — all with a focus on protecting patients and building strong quality cultures.

Whether you work in Quality Assurance, Quality Control, Manufacturing, or Regulatory Affairs, GMP Insider helps you stay compliant, confident, and ahead in an ever-evolving pharmaceutical industry.

New episodes deliver:
• GMP best practices
• Audit readiness strategies
• Real compliance case studies
• Industry trends and updates
• Expert tips from quality professionals

From batch to patient — quality is everything.

Copyright 2026 by Tushar Arora
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    Épisodes
    • Data Integrity in GMP: From Trust to System Control

      Data Integrity in GMP: From Trust to System Control
      Jan 30 2026

      Data integrity issues rarely begin with bad actors — they usually start with convenience.

      In this episode, we examine how FDA auditors identify loss of system control through everyday practices like shared logins, manual entries without review, and backdating documentation. These shortcuts weaken compliance and raise serious red flags during inspections.

      Learn how regulators evaluate whether systems can independently prevent, detect, and correct errors — and why robust design matters more than personal trust.

      Topics covered:
      • The real root causes of data integrity failures
      • What auditors look for beyond data accuracy
      • How weak controls compromise reliable records
      • Designing systems that reduce human dependency
      • Fixing documentation risks before inspection day

      An essential episode for anyone responsible for GMP data and quality systems.
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      16 min
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