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 they do expect companies to investigate mistakes, determine their root causes, and take corrective and preventive actions (CAPAs) to ensure compliance issues don’t recur.

A well-structured CAPA process demonstrates a company’s commitment to regulatory standards and operational excellence. Corrective actions address immediate issues, while preventive actions ensure systemic improvements. When evaluating a potential acquisition, look beyond vendor agreements and examine the entire supply chain. A company with a proactive compliance culture is less likely to face regulatory penalties and will provide greater long-term value.

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