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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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....

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....
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....
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...
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....
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....
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...
clean hold time vs dirty hold time studies in cleaning validation - featured image

Clean Hold Time (CHT) and Dirty Hold Time (DHT) Studies in Cleaning Validation

Explore the critical role of Clean Hold Time (CHT) and Dirty Hold Time (DHT) in cleaning validation. This in-depth guide...
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...
EU GMP Guidelines draft updates: Chapter 4, Annex 11, and new Annex 22 - What is about to change?

2025 EU GMP Draft Updates: Chapter 4, Annex 11, and Annex 22 – What’s Changing?

The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized...

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