Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions
Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.
Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.