CAPA & RCA: A Must for Pharma M&A
When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that enforcement and documentation are essential. If an issue isn’t written down, it effectively never happened. No regulator expects perfection, but t...