Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Evaluating Systemic Manufacturing Compliance and Identifying Actionable Quality Recommendations

Following a string of what appeared to be isolated enforcement actions, a multinational pharmaceutical and medical device company requested Greenleaf’s assistance in evaluating the company’s manufacturing network for systemic compliance concerns.

Greenleaf experts performed audits at 20 different locations in the United States and in six European countries. Two-person baseline audit teams, consisting of experts in manufacturing and analytical testing operations, visited each site and conducted week-long audits assessing each site’s state-of-control. Audits included evaluation of each site’s quality unit, facilities and equipment, materials control, production, labeling and packaging, and analytical operations. Once all baseline audits and site-specific reports had been completed, Greenleaf prepared and submitted a global report assessing the company’s overall state of compliance based on overarching trends and potential systemic concerns observed across the company’s 20 manufacturing sites.  This work resulted in an actionable recommendation for corporate-level corrective action planning in support of the company’s compliance and quality objectives.