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Category: News

The News category provides timely updates on developments that shape GMP compliance across the pharmaceutical industry. It brings together regulatory changes, FDA and EMA communications, inspection findings, warning letters, and product recalls, highlighting how external events influence daily operations.

With clear context and analysis, this section supports proactive decision-making and helps companies remain aligned with global GMP standards.

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FDA Warning Letter Analysis: Catalent Indiana, LLC

This FDA Warning Letter analysis examines how weak investigations, ineffective contamination control strategies, and batch-release-driven decision making allowed contamination risks...
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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...
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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....
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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....
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FDA New Guidance on CSA in 2025 - Featured Image

FDA’s 2025 Guidance on CSA: What Manufacturers Need to Know

FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....
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FDA Warning Letter to Somerset Therapeutics Pvt. Ltd. (India) Issued September 2025

FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
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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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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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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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