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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The role of Batch Manufacturing Records - BMR in GMP

The Role of Batch Manufacturing Records (BMR) in GMP

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards....

Data Integrity in Chromatographic Peak Integration

An essential guide to maintaining data integrity in chromatographic peak integration for QC laboratories....
Corrective and Preventive Actions (CAPA) Plan in GMP

Corrective and Preventive Action (CAPA) Plan in GMP

Explore CAPA's role in GMP for pharmaceuticals: key processes, challenges, and strategies for regulatory compliance...
Worst Case Selection in Cleaning Validation

Worst Case Selection in Cleaning Validation

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
2024 Cannabis Flower Ph.Eur Monograph

2024 Cannabis Flower Ph.Eur Monograph: A Walkthrough

Explore the new 2024 Cannabis Flower Ph.Eur Monograph, setting new quality standards for medicinal cannabis from July 1, 2024....
Cleanroom Qualification and Validation in GMP

Cleanroom Qualification and Validation in GMP

Explore the critical steps of cleanroom qualification and validation within GMP environments, emphasizing the importance of design, operational standards, and...
EDQM Presents 10 Deficiencies in New CEP Applications for Chemical Purity

EDQM Presents 10 Common Deficiencies in New CEP Applications for Chemical Purity

EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications...
Person Performing Process Validation Lifecycle

Process Validation Lifecycle: Risk-Based Approach

Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to...
Gas Chromatography for testing residual solvents in GMP

Residual Solvents in GMP: Classes, Guidelines and Testing

Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP....
People performing Process Validation in GMP facility

Process Validation in GMP

Discover the essentials of Process Validation in GMP, ensuring pharmaceutical quality through scientific and regulatory practices....

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