Confirms that these excipients meet EXCiPACT Good Manufactuing Practices
BASF has received EXCiPACT certification for its polyvinylpyrrolidone (Kollidon) polymers, produced in Ludwigshafen, Germany.
The certificate was issued by Medical Device Certification (MDC), one of EXCiPACT’s internationally-recognised Certification Bodies, and demonstrates that BASF manufactures and distributes pharmaceutical excipients according to the EXCiPACT Good Manu-facturing 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.
BASF will conduct re-certification audits every three years, plus annual surveillance audits to ensure the continued safety and quality of its 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 US FDA 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 only one audit is required to prove that an excipient complies with current GMP and GDP requirements.
‘BASF is the third company which has been certified by EXCiPACT,’ said 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.’