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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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....
Mold contamination in cleanrooms featured image showing mold growth on an agar plate under laboratory light.

Mold Contamination in Cleanrooms: An Invisible but Critical Threat

Even modern cleanrooms face mold risks from HVAC systems, materials, and humidity. Understand how maintenance and monitoring programs can prevent...
Software Validation in GMP featured image with digital binary code and compliance theme.

Software Validation in GMP: Continuous, Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
Quality Risk Management in Computer System Validation (CSV) featured image with digital compliance and validation icons.

Quality Risk Management in Computer System Validation (CSV)

Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
CSV vs CSA software validation differences – featured image showing a professional using a laptop with digital icons representing compliance, documentation, and data security.

CSV vs CSA: Key Differences in Software Validation

Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
Pre Use Post Sterilisation Integrity Testing (PUPSIT) According to Annex 1 - Featured Image

Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in Annex 1

Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Bioburden testing in the pharmaceutical industry - featured image

Bioburden Testing in the Pharmaceutical Industry

Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....

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