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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

Featured image for a GMP Insiders article on USP Pharmacopeial Forum 52(5), showing regulatory documents clipped together. The issue includes proposals on oral drug product leachables, glycol impurity testing, and revisions to compendial Identification requirements.

USP PF 52(5): New General Chapter ⟨1664.5⟩ on Oral Drug Product Leachables, Revised ⟨469⟩ Glycol Test, and General Notices Revisions

USP Pharmacopeial Forum 52(5) introduces proposals covering oral drug product leachables, glycol impurity testing in ethoxylated substances, and revisions to...
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New Swissmedic pharmacovigilance guidance on requirements for the Responsible Person for Pharmacovigilance and deputy.

Swissmedic Guidance MU100_00_001: Requirements of the Responsible Person for Pharmacovigilance, Valid from September 2026

Swissmedic has issued new guidance defining requirements for the Responsible Person for Pharmacovigilance and deputy, including qualifications, duties and oversight....
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Featured image for a GMP Insiders news article on EMA’s revised Shortage Prevention Plan framework, showing a pharmaceutical supply warehouse with stocked pallets. The update introduces new risk thresholds, market-share criteria, and a two-day SPP submission requirement.

EMA Revises the Shortage Prevention Plan Risk Assessment Ahead of the Mid-2027 Legal Deadline

EMA has revised its Shortage Prevention Plan guidance, introducing new risk assessment criteria, market-share thresholds, supply chain classifications, and a...
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eatured image for a GMP Insiders news article on the proposed Ph. Eur. GC method for macrogols, showing gas chromatography laboratory equipment. The EDQM proposal introduces a redesigned GC procedure and new controls for ethylene glycol and diethylene glycol in Macrogols (1444).

Ph. Eur. Proposes a New Gas Chromatographic Control for Ethylene Glycol and Diethylene Glycol in Macrogols (1444)

Ph. Eur. proposes a new capillary GC method and tighter limits for ethylene glycol and diethylene glycol in Macrogols (1444)....
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fda-warning-letter-analysis

FDA Warning Letter Analysis: Dabur India Limited

FDA Warning Letter analysis of Dabur India Limited covering CGMP violations, data integrity failures, import alert, recalls and remediation expectations....
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Featured image for a news article about the new PIC/S Qualification and Validation Guidance (PI 006-4), highlighting major updates to process validation, cleaning validation, equipment qualification, and quality risk management effective from August 2026.

PIC/S Issues PI 006-4 on Qualification and Validation, Effective 1 October 2026

PIC/S PI 006-4 introduces major updates to qualification and validation, including process validation, cleaning validation, qualification, data integrity, and quality...
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Featured image for a GMP Insiders news article on EMA's Q&A guidance for microbial contamination control in non-sterile medicinal products. The graphic shows regulatory documents clipped together, representing new EMA expectations for contamination control, cleaning validation, and quality risk management in pharmaceutical manufacturing.

EMA Issues Q&A Guidance on Technical and Organizational Controls for Microbial Contamination in Non-Sterile Medicinal Products

The European Medicines Agency has published a new Q&A clarifying GMP expectations for preventing microbial contamination in non-sterile medicinal products....
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Featured image for a GMP Insiders news article on Pharmeuropa 38.3 showing a document being officially stamped, highlighting proposed European Pharmacopoeia draft revisions for microbiological quality, pesticide residues, and delivered dose testing.

Pharmeuropa 38.3: Proposed Ph. Eur. Updates for Microbiological Quality, Pesticide Residues and Delivered Dose Testing

Pharmeuropa 38.3 introduces proposed European Pharmacopoeia revisions affecting microbiological quality, pesticide residues, and delivered dose testing. This article explains the...
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FDA revises Preapproval Inspection (PAI) Compliance Program 7346.832, featured image showing regulatory documents and inspection records representing FDA risk-based pharmaceutical inspections.

FDA Rewrites Its Preapproval Inspection Playbook: Revised Compliance Program 7346.832

FDA's revised Compliance Program 7346.832 changes how Preapproval Inspections (PAIs) are planned, scoped, and conducted using a more risk-based inspection...
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Revised EU GMP Annex 19 published, with a regulatory document being stamped and the subtitle on reference and retention samples before September 2026.

Revised EU GMP Annex 19: What Changes for Reference and Retention Samples?

The 2026 revision of EU GMP Annex 19 introduces focused updates for reference and retention samples, mainly affecting parallel trade,...
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