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-recognized certification bodies. The certification demonstrates that BASF manufacturers and distributes pharmaceutical excipients according to the EXCiPACT GMP.
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, BASF reports. The US Food and Drug Administration and the European Medicines Agency require drug producers to qualify excipient suppliers and 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, according to a BASF statement.
BASF is the third company that has been certified by EXCiPACT according to the EXCiPACT Association’s Global Steering Committee. BASF will conduct recertification audits every three years, plus annual surveillance audits to ensure the continued safety and quality of excipients.