OR WAIT null SECS
August 02, 2008
Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.
July 02, 2008
They may have seemed harmless at first, but these ideas took a big bite.
July 01, 2008
At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.
How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?
June 02, 2008
Customers complaining lead to some serious explaining.
May 02, 2008
WFI system deficiencies and damp tax records cause problems for two plants
May 01, 2008
The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.
When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.
Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.
April 02, 2008
Essential components of a good inspection: good ingredients, proper inserts, and ... deer?