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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Featured image titled ‘What Is GAMP 5?’ showing a laboratory software engineer working at a computer with code on screen, used for an article explaining GAMP 5 risk-based validation, software categories, and regulatory alignment.

GAMP 5 in CSV: Definition, Categories, and Pharma Guidelines

Understand GAMP 5 with simple guidance on lifecycle control, validation deliverables, software categories, and risk-based decision-making in GMP environments....
Featured image for primary vs secondary reference standards in GMP labs showing laboratory handling of reference materials.

Primary vs Secondary Reference Standards in GMP Labs

Primary vs secondary reference standards explained: definitions, qualification, traceability, uncertainty, and regulatory expectations in GMP labs....
ISO 5 cleanroom requirements infographic showing airflow design, monitoring strategies, and validation elements according to ISO 14644-1.

ISO Class 5 Cleanroom Requirements According to ISO 14644-1

Overview of ISO 5 cleanroom standards, airflow control, monitoring requirements, and qualification steps under ISO 14644-1...
Featured image for change control in the pharmaceutical industry, highlighting risk-based change classification, workflow, and regulatory expectations.

Change Control in Pharmaceutical Industry

Learn how GMP change control in pharma manages modifications through risk assessment, approval, and documentation to maintain regulatory compliance....
Featured image showing laboratory documentation and the title “5 Key Differences Between OOS, OOT, and OOE Results.”

5 Key Differences Between OOS, OOT and OOE Results

Learn the key differences between OOS, OOT, and OOE results, how each directs investigation depth, CAPA actions, and regulatory response...
Cleanroom equipment with text overlay showing comparison of qualification and validation in GMP.

Qualification vs Validation: Key Differences in GMP

Qualification vs. Validation explained for GMP professionals — clear regulatory differences, lifecycle expectations, and real-world applications across pharma systems....
Featured image showing a high-shear granulator used in wet and dry granulation processes for pharmaceuticals.

Granulation Techniques Comparison: Wet vs. Dry Granulation

A technical comparison of wet and dry granulation techniques with focus on process control, scalability, PAT tools, and continuous manufacturing...
Analyzing migrated data in PMS featured image showing cloud data validation and migration process.

Analyzing Migrated Data in PMS: Practical Guidance for Pharma Professionals

Learn how to validate PMS migrated data using Excel checks to find missing fields, duplicates, and SPOR misalignments before EMA...
Different types of pharmaceutical packaging — primary, secondary, and tertiary packaging illustration.

Different Types of Pharmaceutical Packaging Used in GMP

What are the types of pharmaceutical packaging? Primary, secondary, and tertiary packaging protect medicines through GMP-compliant systems....
HPLC vs UPLC Key Differences

HPLC vs UPLC: Differences in Application, Performance and Cost

What’s the difference between HPLC and UPLC? Compare speed, cost, resolution, and regulatory fit for pharmaceutical analysis....

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