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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deviation management process featured image

Deviation Management Process in GMP

Explore the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality...
usp-233 elemental impurities procedures adopt the harmonized standard

Harmonized Standard for USP <233> Elemental Impurities—Procedures Adopted

Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....
rabs-vs-isolators-fi

RABS vs Isolators: Which Barrier System Meets Annex 1 Expectations?

RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
Method validation vs method verification: Key Differences

Difference Between Validation and Verification of Analytical Methods

Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and...
Melt granulation process (Principles, Mechanisms, and practical applications)

Melt Granulation: Principles, Mechanism, and Applications

Solvent-free melt granulation improves flowability, compressibility, and drug release. Learn its process, advantages, equipment, and pharma applications....
Difference between reference and retention samples

Reference vs Retention Samples: What is the Difference?

Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory...
How to Select and Justify the Right Biological Safety Cabinet for the Laboratory

How to Select the Right Biological Safety Cabinet (BSC) for the Lab?

Learn how to choose the right Biological Safety Cabinet (BSC) for your lab. Explore BSC types, features, biosafety levels, and...
6 Steps on How to Perform Root Cause Analysis (RCA)

6 Steps on How to Perform Root Cause Analysis (RCA)

Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance...
Contamination, Cross-Contamination, and Mix-Ups in Pharmaceutical Manufacturing

Contamination, Cross-Contamination, and Mix-Ups in GMP

Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance....
Types of Airlocks Used in the Pharmaceutical Industry

Types of Airlocks Used in the Pharmaceutical Industry

Explore types of airlocks in pharma: Cascade, Bubble, Sink. Learn how they ensure contamination control, cleanroom integrity, and GMP compliance....

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