Author: GMP Insiders Expert Team

The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.

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Analyzing migrated data in PMS featured image showing cloud data validation and migration process.

Analyzing Migrated Data in PMS: Practical Guidance for Pharma Professionals

Learn how to validate PMS migrated data using Excel checks to find missing fields, duplicates, and SPOR misalignments before EMA...
Different types of pharmaceutical packaging — primary, secondary, and tertiary packaging illustration.

Different Types of Pharmaceutical Packaging Used in GMP

What are the types of pharmaceutical packaging? Primary, secondary, and tertiary packaging protect medicines through GMP-compliant systems....
New Drafts release in Pharmeuropa 37.4. October 2025.

Pharmeuropa 37.4: New Drafts Released for Public Consultation

Pharmeuropa 37.4 introduces updates to residual solvents (2.4.24), cannabis flower (3028), and rubber closures (3.2.9) to improve analytical clarity....
HPLC vs UPLC Key Differences

HPLC vs UPLC: Differences in Application, Performance and Cost

What’s the difference between HPLC and UPLC? Compare speed, cost, resolution, and regulatory fit for pharmaceutical analysis....
Software Validation in GMP featured image with digital binary code and compliance theme.

Continuous Software Validation in GMP: Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
Quality Risk Management in Computer System Validation (CSV) featured image with digital compliance and validation icons.

Quality Risk Management in Computer System Validation (CSV)

Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
CSV vs CSA software validation differences – featured image showing a professional using a laptop with digital icons representing compliance, documentation, and data security.

CSV vs CSA: Key Differences in Software Validation

Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
FDA New Guidance on CSA in 2025 - Featured Image

FDA’s 2025 Guidance on CSA: What Manufacturers Need to Know

FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....
fda-warning-letter-analysis

FDA Warning Letter to Somerset Therapeutics Pvt. Ltd. (India) Issued September 2025

FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....

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