Good Manufacturing Practice (GMP)



IT Validation – the Direct Way to Compliance
There is rarely a topic which polarizes experts more than the validation of IT-systems. Some would even comprehensively validate systems which only have a remote influence on product quality while others undervalue the meaning of obviously critical systems. A huge uncertainty can be observed everywhere as well as constant competition between too much and too little until the point of a complete and an escape to the good old world of paper.



7 Steps to GMP Compliance
Updating Chinese GMP Guidelines - The Chinese know that implementing good manufacturing practice (GMP) is a prerequisite for a certificate but in the past, the Chinese GMP system could not be compared to Western GMP standards.





Bio Evaluation
EXCiPACT
IPEC Europe
Sartorius AG
Lonza AG
International Society for Pharmaceutical Engineering (ISPE)
Azelis Corporate Services NV
Forma Life Sciences
Patheon Italia
Dottikon Exclusive Synthesis AG
Hochschule Koblenz
Rotego Chem
Concept Heidelberg
Chemgineering Technology GmbH
WeylChem International GmbH
Novozymes Biopharma UK Ltd.
Ferak Berlin GmbH
Siemens AG Industry Automation Division
gempex GmbH – THE GMP-EXPERT
Symbiosis Pharmaceutical Services
Clariant International Ltd
ISPE D/A/CH e.V.
Trinseo LLC
Merck KGaA
Society of Chemical Manufacturers & Affiliates (SOCMA)
Thomson Reuters
Press'n'Relations GmbH Niederlassung Berlin















