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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Pre Use Post Sterilisation Integrity Testing (PUPSIT) According to Annex 1 - Featured Image

Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in Annex 1

Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Bioburden testing in the pharmaceutical industry - featured image

Bioburden Testing in the Pharmaceutical Industry

Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....
types of hepa filters used in the pharmaceutical industry - featured image

Types of HEPA Filters Used in the Pharmaceutical Industry

Explore HEPA filter types used in pharmaceutical cleanrooms. Understand H13 vs H14, ULPA, gel-sealed filters, and Annex 1 testing requirements....
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...
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....
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....
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...

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