BASF Receives EXCiPACT Certification as Pharma Excipient Supplier

BASF has received the EXCiPACT certificate for pharmaceutical excipients for the group of polyvinylpyrrolidone (Kollidon) polymers, produced in Ludwigshafen, Germany. The certificate was issued by mdc medical device certification GmbH — one of EXCiPACT’s internationally-recognised certification bodies.

The certification demonstrates that BASF manufactures and distributes pharmaceutical excipients according to the EXCiPACT GMPs. “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 business unit. “With our Kollidon portfolio, we ensure to achieve the highest standards in regulatory, quality and safety.” BASF will conduct recertification audits every three years, plus annual surveillance audits to ensure the continued safety and quality of excipients.

The EXCiPACT scheme can be made available when the regulators in the EU and US require the holder of the marketing authorisation for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The FDA and the EMA continue to require drug producers to qualify their excipient suppliers appropriately and, as a result, the suppliers must be prepared to receive increasing numbers of audits from their customers.

EXCiPACT helps to avoid additional audits in a cost-effective manner for all parties concerned because one single audit will be all it takes to prove an excipient complies with current GMP and GDP requirements. “BASF is the third company that has been certified by EXCiPACT,” said Dr. Iain Moore, Chairman of the EXCiPACT Association’s Global Steering Committee. “With the certificate, we minimise risks for customers and help ensure patient safety while reducing costs.”

BASF SE, +49 621 60 48978, nina.osten@basf.com, www.basf.com.

EXCiPACT, +32 2 736 53 54, info@excipact.org, www.excipact.org.