What is a GMP Audit? | Pharma Compliance Basics
Автор: Help Me GMP | GMP GDP Pharma Training | HelpMeGMP
Загружено: 2025-04-10
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What is a GMP Audit? | Pharma Compliance Basics @HelpMeGMP
Wondering what a GMP audit actually is? In this short video from our GMP Basics Series, we break down the essentials of a Good Manufacturing Practice (GMP) audit—why it's done, who performs it, and what it means for pharmaceutical compliance.
A GMP audit is a structured inspection that evaluates whether pharmaceutical manufacturing processes, systems, and documentation comply with Good Manufacturing Practice standards. These audits are conducted by regulatory bodies like the MHRA, FDA, EMA, or by internal quality teams and third-party auditors. Their goal? To ensure patient safety by verifying that drugs are consistently produced and controlled to quality standards.
✅ What You'll Learn:
What is a GMP audit?
Who performs GMP audits (regulators, internal teams, 3rd parties)?
Why audits are essential for maintaining pharmaceutical quality.
How audits help identify gaps and drive continuous improvement.
What you can do to prepare for your next audit.
📌 Why It Matters:
GMP audits are a critical component of compliance in the pharmaceutical industry. A successful audit ensures that your facility is following the correct procedures to maintain safety, quality, and integrity. Failing an audit can lead to regulatory warnings, product recalls, or even shutdowns. This is why understanding GMP audits is essential for everyone working in QA, QC, Regulatory Affairs, and Manufacturing.
👨🏫 Who Should Watch This Short?
New pharma employees learning GMP basics
QA/QC and Compliance professionals
Regulatory Affairs staff
Students entering the pharmaceutical industry
Anyone preparing for a GMP inspection
📚 Explore More in Our GMP Basics Series: 📌 What is GMP? | GMP Basics in 60 Seconds
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📌 What is a Deviation in GMP?
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📌 What is Change Control? Why It Matters in GMP
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📌 What is Validation in Pharma? Explained Fast
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📢 Understanding audits is the first step to staying compliant. Watch now and level up your GMP knowledge in under 60 seconds!
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