Article archive

Revised Annex 16: Comments of the European QP Association

18/11/2013 13:02
In July this year, the European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Stakeholders were invited to comment on this draft. As the major interest group of Qualified Persons in Europe, the European QP...

European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

18/11/2013 12:56
European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a second joint question-and-answer document that provides guidance on...

"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5

18/10/2013 04:26
  Hi Friends!   In addition to my website, I created a mobile application named by "SRK GMP OCEAN" works for Android, Blackberry, Iphone, Windows mobile Device (all smart phones)..... Now You can swim in GMP OCEAN using your mobile....This is purely free ..... Please remember to give...

New FDA Fees for Drug Master Files published

18/10/2013 00:26
The US FDA has published the new fees for 2014. In a Federal Register Statement dated August 2, 2013 the following information has been published: Under the Generic Drug User Fee Act (GDUFA), the Drug Master File (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient...

Cleaning Validation Requirements in Asia

17/10/2013 23:37
Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and APIs manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs...

Teva Pharmaceutical to cut 5,000 jobs, save $2 bn annually

17/10/2013 23:29
Teva Pharmaceutical to cut 5,000 jobs, save $2 bn annually  

Zydus, Germany’s Pieris tie up to develop `Anticalin’ protein drugs

17/10/2013 23:25
Zydus, Germany’s Pieris tie up to develop `Anticalin’ protein drugs

New MHRA's Webpage on the Falsified Medicines Directive

17/10/2013 23:21
The Directive on the prevention of the entry of falsified medicines into the legal supply chain, 2011/62/EU, (also called "Falsified Medicines Directive") came into force at the beginning of 2013. This regulation contains a range of provisions with significant influence on Europe's pharmaceutical...

USFDA increases inspection staff in India

17/10/2013 23:18
    With more pharmaceutical products coming from India and the quality problems encountered there, FDA has increased its inspection staff by 60%. Read a news account from an India newspaper as well as an article written by Altaf Ahmed Lal, Ph.D., the Director of FDA’s India office....

U.S. FDA Clearance for Mass Spectrometry

17/10/2013 23:08
bioMérieux announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of...
Items: 211 - 220 of 337
<< 20 | 21 | 22 | 23 | 24 >>