Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 BASF Gains EXCiPACT Certification | Contract Pharma

What are you searching for?

Sign in
Breaking News

BASF Gains EXCiPACT Certification

Kollidon polymers meet cGMP requirements

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

BASF has received EXCiPACT Certification for pharmaceutical excipients for a group of its polyvinylpyrrolidone (Kollidon) polymers produced in Ludwigshafen. The certificate was issued by mdc medical device certification GmbH, one of EXCiPACT’s certification bodies.
 
The certification demonstrates that BASF manufactures and distributes pharmaceutical excipients according to EXCiPACT GMP. BASF will conduct recertification audits every three years along with annual surveillance audits to ensure continued compliance.
 
“With the certificate we confirm that our customers only get the highest quality excipients,” said Franҫois Scheffler, vice president global marketing at BASF Pharma Ingredients & Services unit. “With our Kollidon portfolio we ensure to achieve the highest standards in regulatory, quality and safety.”
 
The FDA and EMA require drug producers to qualify their excipient suppliers, which can result in numerous audits. EXCiPACT helps to avoid additional audits because one single audit proves an excipient complies with cGMP and GDP requirements.
 
For more about EXCiPACT certification, read our interview with Frithjof Holtz of Merck Millipore about his company’s experience with the process.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics