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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A hand pointing on a screen with chromatograms showing peak tailing

Peak Tailing in Chromatography: Troubleshooting Basics

Explore the essentials of troubleshooting peak tailing, including pro tips, and suggestions for accurate and reliable chromatography....
Defining Specification Limits for Unknown, Known and Total Impurities in New Drug Products with HPLC

Defining Specification Limits for Impurities in New Drug Products

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and...
Person working in QC Lab - LC

Impurities in Pharmaceuticals: Types, Regulations and Strategies

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...
Electronic Quality Management System eQMS

Electronic Quality Management Systems – eQMS

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence,...
Topical Ophthalmic Drug Products

FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products

Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for...
GMP Regulatory Bodies

GMP Regulatory Bodies: Understanding the Key Differences

Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide....
GDP Warehouse and man with forklift

Good Distribution Practice – GDP in the Pharmaceutical Industry

Elevate pharmaceutical supply chain integrity with Good Distribution Practice (GDP). Ensure quality, safety, and compliance in every step....
GxP - Person working in laboratory

Understanding GxP Regulations in The Pharmaceutical Industry

Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory...
Laboratory equipped with instruments, chairs, glassware

Performance Characteristics in Analytical Method Validation: Understanding the Significance

Learn how method validation performance characteristics align with GMP to ensure consistent industry-compliant results....
The-Importance-of-Analytical-Method-Validation

Analytical Method Validation & Its Role in Lab Testing

An overview of analytical method validation and its critical impact on testing accuracy, reliability, and compliance with regulatory standards....

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