IPEC: Updated Position Paper on Third Party Audits

The International Pharmaceutical Excipients Council (IPEC) Federation has released an update of its position paper advocating for independent third party audits and certification programs. The position paper was first published in September 2015.

Key Highlights:

• Regulatory and Industry Challenges: Increasing regulatory demands require pharmaceutical manufacturers to source excipients from reputable suppliers, placing a significant audit burden on both suppliers and users.
• Third-Party Auditing Benefits: Independent audits improve impartiality, enhance GMP compliance, and reduce the need for repetitive audits by multiple customers.
• Certification Standards: Third-party audits follow internationally recognized standards, such as ISO 17021 and ISO 17065, ensuring credibility and consistency.
• Regulatory Alignment: Certification schemes align with regulatory requirements, including the EU’s Falsified Medicines Directive and the U.S. FDA’s Safety and Innovation Act.
• Industry-Wide Efficiency: Adoption of third-party certification helps reduce costs, resources, and time for both excipient suppliers and users.

According to IPEC, the use of third-party audit and certification schemes helps to reduce costs, time and resources for both excipient suppliers and users. Such third-party audit and certification schemes both raise quality expectations to an industry-accepted level and improve patient safety.

Source:

IPEC: News