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.