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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FDA Issues Warning Letter Due to cGMP Violations

FDA Issues Warning Letter Due to cGMP Violations

FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....
Cold Chain Management in the Pharmaceutical Industry

Cold Chain Management in the Pharmaceutical Industry

Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines...
Calibration, handling and maintenance of pH meters

Calibration, Handling and Maintenance of pH Meters

Discover essential tips for calibration, handling, and maintenance of pH meters in QC labs....
Product Quality Review (PQR)

Product Quality Review – PQR In GMP

Read more on the best practices for conducting effective PQRs, covering the key components, objectives, and challenges in GMP....
Airflow Visualization Smoke Studies (AVS) in Cleanrooms

Airflow Visualization Smoke Studies (AVS) in Cleanrooms

Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical...
Calibration and Performance Checks of Analytical Balances

Calibration of Analytical Balances and Performance Checks

Ensure precision in QC labs with proper calibration and performance checks of analytical balances. Learn best practices for reliable and...
Challenge Tests for Blister Machines

Challenge Tests for Blister Machines

Explore the significance of challenge tests for blister machines in the pharmaceutical industry, ensuring the detection and rejection of defective...
Laminar Flow Cabinets - LFC - Types and Applications in GMP Facilities

Laminar Flow Cabinets in GMP Facilities: Types & Application

Discover the importance, types, and regulatory requirements of laminar flow cabinets in GMP regulated environment....
The role of Batch Manufacturing Records - BMR in GMP

The Role of Batch Manufacturing Records (BMR) in GMP

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards....

Data Integrity in Chromatographic Peak Integration

An essential guide to maintaining data integrity in chromatographic peak integration for QC laboratories....

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