India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

Posted on

New Drug Approvals

 

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

The pressure on India is getting bigger because of GMP deficiencies found during inspections. An article of the news agency Reuters summarised impressive information on the topic. Read more here about the Reuters article.

read here

http://www.gmp-compliance.org/enews_4294_India%20under%20Pressure%3A%20GMP%20Conformity%20Not%20Guaranteed%20in%20many%20APIs%20Facilities_8500,S-WKS_n.html

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

The pressure on India is getting bigger because of GMP deficiencies found during inspections. A wide range of FDA Warning Letters and FDA Import Alerts are given special attention. The GMP deviations observed are extreme and partly alarming with regard to the potential risks for the patients. Even elementary GMP requirements have been neglected. Production areas were often found in an uncontrolled status (risk of cross contamination) that medicinal products had to be recalled. The Warning Letter for Wockhardt is one of the most prominent examples. According to an…

View original post 469 more words

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s