📢 DDReg Knowledge Capsule – Episode [23]importance of maintaining rigorous oversight of external vendors within the international pharmaceutical and medical device sectors. It explains that regulatory bodies hold the primary product owners directly accountable for any quality failures, regardless of where manufacturing or material sourcing occurs. To mitigate these risks, the source advocates for a structured governance model that uses risk-based assessments to determine the intensity and frequency of supplier evaluations. Furthermore, it details how formal quality agreements, comprehensive audits, and continuous performance tracking are essential tools for ensuring global compliance. Ultimately, the text asserts that integrating digital quality systems and expert-led monitoring is necessary to satisfy legal requirements and protect patient safety.
https://resource.ddregpharma.com/blogs/managing-supplier-compliance-and-audits-across-global-networks/