This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for...

Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP …

Jul 2, 2011 · EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of …

Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice …

Aug 8, 2025 · Learn about GMP guidelines, how to uphold GMP standards, and technology for commercial and industrial good manufacturing practices (GMPs).

The GMP Guideline Database contains more than 1,200 GMP Guidelines e.g. from EU/EMA, FDA, ICH, PIC/S, WHO as well as industry interpretation from PDA, ISPE, IPEC, APIC and many more. You …

This guide covers the fundamentals of Good Manufacturing Practices (GMP), the 10 key elements for compliance, the GMP process, best practices, and FDA inspection insights.

1 day ago · Learn what Good Manufacturing Practices (GMP) are, their basic requirements, cGMP, EU GMP, and why GMP is essential for pharmaceutical quality and safety.

Nov 21, 2025 · FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.

This comprehensive guide explores current GMP requirements, implementation strategies, and emerging challenges facing pharmaceutical manufacturers worldwide. What Are Good Manufacturing …