Tag: GMP

Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.

Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical for aseptic environments.

Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the pharmaceutical industry.

Explore the significance of challenge tests for blister machines in the pharmaceutical industry, ensuring the detection and rejection of defective packs to maintain product quality and safety.

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

EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications for chemical purity in 2023.

Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to commercialization, meeting critical specifications.

Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP.

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

Exploring Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) - essential steps in ensuring equipment quality and compliance in GMP facilities.