• gmp-verlag.de
  • GMP Compliance Adviser Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


3. GDP Audit Questionnaire
More than 700 questions with reference to regulations.


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> More Downloads

News about GMP/cGMP

2018-09-14

Second Impurity Found in Valsartan

Health Canada has identified a second impurity, N‑nitrosodiethylamine (NDEA) in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China. All drugs containing valsartan manufactured from that source have already been recalled in Canada after the first impurity, N-nitrosodimethylamine (NDMA), was identified earlier this summer. Both, NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could cause cancer.

 

Besides Health Canada, also the EMA and the US FDA have released further reviews on valsartan medicines. Together with other international regulatory partners they are investigating the root cause of the issue. The EMA’s risk assessment considers the life-time risk of cancer to be low. It is estimated to be in order of 1 in 5,000 for an adult patient who had taken an affected valsartan medicine at the highest dose (320 mg) every day from July 2012 to July 2018. The low risk estimate is to some extent supported by a Danish study which tracked patients who had taken medicines containing valsartan from Zhejiang Huahai over the past 6 years. However, the authors note that patients were followed up for a relatively short period (4.6 years on average).

Data on levels of NDEA are currently very limited, and both, Health Canada and EMA will provide further information on whether its presence impacts the risk assessment once more information becomes available. Meanwhile EU authorities have carried out inspections of the manufacturing sites of the involved companies (Zhejiang Huahai and Zhejiang Tianyu) in China and will consider the findings.

Medicines containing valsartan from the two manufacturers are no longer distributed in the EU or have been recalled. Both companies are not currently authorised to produce valsartan for medicines in the EU.

The US FDA has also updated its investigation results and also reports on the finding of the additional impurity NDEA identified in products of Torrent Pharmaceuticals Ltd. Torrent’s valsartan was already part of an earlier recall of August 2018. The API used again originated from Zhejiang Huahai Pharmaceuticals. Currently the FDA is continuing to test all products that contain valsartan for NDEA and related impurities.

Source:

Health Canada: Recalls and Alerts

EMA: Press Release

FDA: Press Announcement

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
Questionnaire for preparing GMP-inspections
GMP Compliance Adviser
Single User Licence (monthly subscription)
GMP Fundamentals – A Step-by-Step Guide (download)