Direkt-Links zu wichtigen GMP Guidelines

Guidelines für GMP-Inspektoren, um eine einheitliche Vorgehensweise bei der Inspektion aller Aspekte des Steriltests zu erreichen.

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics.

This document specifies the quality system requirements for National pharmaceutical inspection services concerned with good manufacturing practice and good wholesale distribution practice of medicinal products.

The Aide-Memoire describes different areas which could be evaluated during the GMP inspection of HVAC systems, pharmaceutical water, steam and medicinal gases.