Published on June 18, 2024, this rule revises requirements around current good manufacturing practice (CGMP), post-marketing ...

As FDA inspections return, ... some regulations have changed, ... evidence that the data is a true and accurate representation of the GMP readiness of facilities.

Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ResearchAndMarkets.com's offering. cGMP or current ...

Pharmaceutical CGMP manufacturing encompasses all processes that abide by these guidelines to ensure drug products meet required standards from raw material sourcing to final product distribution.

Conducted in compliance with GMP guidelines, release testing ensures that every batch of a drug leaving the manufacturing facility is safe for consumption and effective for its intended use. The scope ...

Gap between domestic GMP & GMP required for intl compliance is huge: Dr Amaresh Tumbagi: Nandita Vijayasimha, Bengaluru Friday, June 27, 2025, 08:00 Hrs [IST] Drug regulators have ...

The audit by the FDA found "deviations" from Current Good Manufacturing Practice (cGMP), which are a system of regulations by the FDA to ensure safety, effectiveness and purity of pharmaceuticals ...