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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Gas Chromatography for testing residual solvents in GMP

Residual Solvents in GMP: Classes, Guidelines and Testing

Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP....
People performing Process Validation in GMP facility

Process Validation in GMP

Discover the essentials of Process Validation in GMP, ensuring pharmaceutical quality through scientific and regulatory practices....
FAT and SAT in GMP Importance in Equipment Validation

FAT and SAT in GMP: Importance in Equipment Validation

Exploring Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) - essential steps in ensuring equipment quality and compliance in...
GMP vs GLP - 10 Key Aspects for Quality and Compliance

GMP vs GLP: 10 Key Differences for Quality and Compliance

Explore the key differences of GMP vs GLP and how these practices warrant the highest industry standards....
Temperature Mapping in GxP Environment

Temperature Mapping in GxP Environment

Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage....
Out of Specification Results Dealing with OOS Investigations in Pharma

Out of Specification Results: OOS Investigations in Pharma

Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry...
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....
Differences Between OOS, OOT and OOE Results

5 Key Differences Between OOS, OOT and OOE Results

Look into the five key differences between OOS, OOT, and OOE results, the regulatory requirements and their importance in the...
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...

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