Brussels, Belgium / Ludwigshafen, Germany – January 8, 2014 – BASF has received the EXCiPACTTM Certificate for pharmaceutical excipients for the group of polyvinylpyrrolidone (Kollidon®) polymers, produced in Ludwigshafen. The certificate was issued by mdc medical device certification GmbH - one of EXCiPACT’s internationally-recognized Certification Bodies.
The certification demonstrates that BASF manufactures and distributes pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practices (GMP). “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 USA require the holder of the marketing authorization for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The US Food and Drug Administration and the European Medicines Agency 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 which has been certified by EXCiPACT,” said Dr. Iain Moore, Chairman of the EXCiPACT Association’s Global Steering Committee. “With the certificate we minimize risks for customers and help ensure patient safety while reducing costs.”
About EXCiPACT
EXCiPACT is a project of the IPEC Federation, a global organization to promote quality in pharmaceutical excipients (see www.ipecfed.org ). EXCiPACT is a voluntary international scheme to provide for independent 3rd party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. It will ensure patient safety through supplier quality while minimizing the overall costs for assessing the excipient supply chain. It was launched in January 2012 since when there has been considerable interest among pharmaceutical excipient suppliers, customers and regulators. For further information see www.excipact.org or contact [email protected].
About BASF
BASF is the world’s leading chemical company: The Chemical Company. Its portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. We combine economic success with environmental protection and social responsibility. Through science and innovation, we enable our customers in nearly every industry to meet the current and future needs of society. Our products and solutions contribute to conserving resources, ensuring nutrition and improving quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future. BASF had sales of €72.1 billion in 2012 and more than 110,000 employees as of the end of the year. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information on BASF is available on the Internet at www.basf.com.
Contact:
Carole Capitaine
EXCiPACT
Office
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+32 2 736 53 54
Nina Osten
BASF SE
Global Communications Nutrition & Health
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+49 621 60 48978