Best practices for managing outsourced drug sampling operations include:
Thoroughly vetting and selecting reputable vendors with a proven track record in compliance
Clearly communicating the company’s internal policies, procedures, and expectations to the vendors
Implementing contractual agreements that stipulate compliance with PDMA, 21 CFR Part 11, and other relevant regulations
Regularly monitoring and auditing vendor performance to ensure compliance and detect potential issues
Encouraging open communication and feedback between the company and its vendors to address any concerns or areas for improvement