Author: GMP Insiders Expert Team

The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.

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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...
USP–NF PF 51(6) draft updates announced for November 2025, including revisions to chapters ⟨1225⟩ Analytical Lifecycle, ⟨1771⟩ Ophthalmic Products, ⟨1664.1⟩ and ⟨1664.3⟩ Leachables for OINDP and Eye Drops, and ⟨825⟩ Radiopharmaceutical Standards.

USP–NF PF 51(6) Draft: What is New?

USP–NF PF 51(6) draft updates modernize analytical validation, ophthalmic standards, leachables guidance, and radiopharmaceutical practices....
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....
New Drafts release in Pharmeuropa 37.4. October 2025.

Pharmeuropa 37.4: New Drafts Released for Public Consultation

Pharmeuropa 37.4 introduces updates to residual solvents (2.4.24), cannabis flower (3028), and rubber closures (3.2.9) to improve analytical clarity....
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....
Software Validation in GMP featured image with digital binary code and compliance theme.

Continuous Software Validation in GMP: Risk-Based Control

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....

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