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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FDA Warning Letter Issued to Rhyz Analytical Labs – November 12, 2025

FDA Warning Letter to Rhyz Analytical Labs cites CGMP failures in OOS investigations and Quality Unit oversight at a contract...
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...
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...

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