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 ISPE, 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

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