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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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Author's Latest Publications

Draft Revisions to EudraLex GMP Guide Chapter 1 – Pharmaceutical Quality System

Draft Revisions to EudraLex GMP Guide Chapter 1 – Pharmaceutical Quality System

Draft revisions to GMP Chapter 1 focus on risk-based oversight, early warning systems, supply chain risks, and improved Product Quality...
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USP–NF PF 51(5) Draft RELEASED - Featured Image

USP–NF PF 51(5) Draft: Updates in Microbiology, Distribution, and Dosage Form Guidance

USP–NF PF 51(5) draft introduces updates in microbiology, transport, particulates, and dosage form guidance, emphasizing risk-based GMP compliance....
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CSV in pharmaceutical manufacturing - featured image

Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
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PDF revision on sub-visible particulate contamination in products

PDG Publishes Major Revision to General Chapter on Sub-Visible Particulate Contamination

PDG updates Q09 on sub-visible particulate contamination after 20 years, harmonising standards for safer parenteral medicines....
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Cleanroom Classification According to ISO 14644-1

ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing....
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ICH Q3E Draft Guideline on extractablesICH Q3E Draft Guideline on extractables and leachables - Featured Image and leachables

ICH Q3E Draft Guideline on Extractables and Leachables

ICH Q3E draft outlines global guidance for Extractables & Leachables, covering scope, risk assessment, AET, and regulatory expectations....
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Annex 22 Draft: Regulatory Guidance - Featured Image

Annex 22 Draft: Regulatory Guidance on AI Use in GMP

Annex 22 - EU's new draft regulatory framework for AI in GMP, focusing on model validation, performance, and risk management...
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Quality by design (QbD) in pharmaceutical development - Featured Image

Quality by Design (QbD) In Pharmaceutical Development

Learn how Quality by Design (QbD) ensures consistent pharmaceutical quality through process understanding, risk management, and regulatory alignment....
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supplier qualification management in GMP regulated industry - featured image

Supplier Qualification in GMP – What Do You Need to Consider?

Improve supplier qualification management through practical GMP steps, detailed checklists, audits, and ongoing performance monitoring....
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IDMP Ontology what is it and how to use it in your organization - featured image

IDMP Ontology: What It Is and How It Can Be Used in Your Organization

IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...
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