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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CSV vs CSA: Key Differences in Software Validation

Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
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....
fda-warning-letter-analysis

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....
ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
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....
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Bioburden Testing in the Pharmaceutical Industry

Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....
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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....
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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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