Good Manufacturing Practice (GMP)

Wockhardt Medicines Recalled by MHRA

Boehringer Ingelheim Ohio Subsidiary Enters Consent Decree

Scrum in the Regulated Environment

Product Protection by Implementation of Improved Hygiene Zones

FDA Reform Act Signed into Law

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.

Recombinant Human Albumin

For Increased Patient Safety

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.

Vaccine Production: ‘Best-in-Class’

Flow Chemistry for Hazardous Reactions

Securing Each Step

Turning Point

Improving Efficiencies And Compliance

Safety Takes Priority