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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What is the difference between gmp and cgmp - featured image

GMP vs cGMP: What is the Difference?

GMP vs cGMP—understand what “current” means for today’s quality standards, compliance expectations, and pharma manufacturing practices...
Media Fills In Sterile Manufacturing: Aseptic Process Simulation - Featured Image of Article

Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing

Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....
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Bill of Materials (BOM) in Pharmaceutical Manufacturing

Overview of Bill of Materials in GMP-compliant pharmaceutical manufacturing, including materials, compliance, traceability, version control, and integration....
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Environmental Monitoring in the Pharmaceutical Industry

Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control....
Growth promotion testing (GPT) in pharmaceutical microbiology

Growth Promotion Testing (GPT) in Pharmaceutical Microbiology

Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
FDA Inspection Readiness Guideline: How to prepare for unannounced global audits

FDA Inspection Readiness: How to Prepare for Unannounced Global Audits

Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
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How to Write a GMP-Compliant User Requirement Specification (URS)

Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...
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Risk-Based Contamination Control Strategy (CCS)

Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
GMP Cleanroom

GMP Cleanroom Classifications: Grade A, B, C and D

Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control....
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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...

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