Category: Articles

The Articles category is the central knowledge base of GMP Insiders, offering guidance, analysis, and technical resources across all areas of pharmaceutical compliance. It spans the core foundations of GMP, including quality assurance, quality control, manufacturing, microbiology, distribution, computerized systems, and research and development.

Content is created to support professionals at every level — from daily operations to long-term strategy, by linking regulatory expectations with practical implementation. This section allows readers to explore a broad range of GMP topics in one place, navigate across specialized subcategories, and access resources that strengthen technical expertise and compliance.

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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....
Corrective and Preventive Actions (CAPA) Plan in GMP

Corrective and Prevention Action (CAPA) Plan in GMP

Explore CAPA's role in GMP for pharmaceuticals: key processes, challenges, and strategies for regulatory compliance...
Worst Case Selection in Cleaning Validation

Worst Case Selection in Cleaning Validation

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
2024 Cannabis Flower Ph.Eur Monograph

2024 Cannabis Flower Ph.Eur Monograph: A Walkthrough

Explore the new 2024 Cannabis Flower Ph.Eur Monograph, setting new quality standards for medicinal cannabis from July 1, 2024....
Cleanroom Qualification and Validation in GMP

Cleanroom Qualification and Validation in GMP

Explore the critical steps of cleanroom qualification and validation within GMP environments, emphasizing the importance of design, operational standards, and...
Person Performing Process Validation Lifecycle

Process Validation Lifecycle: Risk-Based Approach

Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to...

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