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.

If you don’t find what you are looking for, try using a different term or contact us.

Cleaning Validation of Equipment in Pharmaceutical Industry

Cleaning Validation In the Pharmaceutical Industry

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards....
Pharmacovigilance

Pharmacovigilance – Ensuring the Safety of Medications

Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management....
Design Review and Design Qualification in the Pharmaceutical Industry

Design Review and Design Qualification in the Pharmaceutical Industry

Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and...
Quality Assurance vs Quality Control in GMP

Quality Assurance vs. Quality Control in GMP: Key differences

Explore the critical differences between Quality Assurance and Quality Control in GMP and learn more about their role within the...
Person measuring a sample on an analytical balance

Analytical Balances for QC Labs Purposes: Proper Weighing Practices

Explore the critical role of analytical balances in QC labs, focusing on operational principles, performance factors, and compliance with industry...
Quality Risk Management Process

Quality Risk Management in the Pharmaceutical Industry

Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety....
A hand pointing on a screen with chromatograms showing peak tailing

Peak Tailing in Chromatography: Troubleshooting Basics

Explore the essentials of troubleshooting peak tailing, including pro tips, and suggestions for accurate and reliable chromatography....
Defining Specification Limits for Unknown, Known and Total Impurities in New Drug Products with HPLC

Defining Specification Limits for Impurities in New Drug Products

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and...
Person working in QC Lab - LC

Impurities in Pharmaceuticals: Types, Regulations and Strategies

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...
Good Documentation Practice - FI

Good Documentation Practices in the Pharmaceutical Industry

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability....

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!