News

New GMP guideline for the manufacture, control and quality management of sterile drugs in consultation --- gempex, now from 3 locations in China, supports companies in the pharmaceutical, chemical and biotech industries --- Guangzhou, Suzhou and new 2025:…

Presentation by gempex at the LOUNGES 2025 --- 27. March 2025, 11-11:30 a.m., Room 3

Supplier documentation according to GMP "out of the box" through standardization and specifics --- Presentation by gempex at the LOUNGES 2025 --- March 26, 2025, 17:00 to 17:30, Room 3

Recommendations, tips and practical experience with FDA investigations --- Technical lecture by FDA and audit expert from gempex at the LOUNGES 2025 --- Karlsruhe, 25.03.2025, 10 AM, Room 3

What needs to be done for an upcoming audit? --- How proceed before, during and after an audit? --- Basic knowledge and know-how --- Tips and practical advice --- Technical lecture from gempex

gempex presents the current service catalog: GMP Consulting & Execution and high-level consulting topics --- Inspection-Readiness, Remediation and Annex 1 Analyses --- gempex offers technical lectures on FDA, GMP Project Management, IT Validation and…

An important process step in the aseptic production of sterile pharmaceutical products --- New technical article from gempex --- Sterilization | Qualification | Validation | Filter integrity tests | Annex 1

gempex supports Sartorius Stedim Biotech GmbH --- The new Ksep® 50 Centrifuge System was, comprehensively tested and qualified, successfully launched on the market.

Live online training with GMP expertise from gempex on February 05/06, 2025 --- ECA Academy GMP Certification Programme

Determination of  measurement uncertainties - when does which approach make sense? --- New specialist information from gempex ---