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.

If you don’t find what you are looking for, try using a different term or contact us.

Good Documentation Practice - FI

Good Documentation Practices in the Pharmaceutical Industry

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability....
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FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products

Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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....
Swissmedicines Inspectorate

SwissMedicines Inspectorate: Interpretation of GMP Annex 1 [2022]

Swissmedicines Inspectorate interprets the 2022 GMP Annex 1 guidelines, offering crucial insights into pharmaceutical manufacturing quality. Stay informed with GMP...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!