CAPA Planning

CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). Thus the focal point of any quality system is CAPA system. An organization’s combined efforts to investigate and correct quality issues – and to prevent their recurrence – are crucial to maintaining compliance with regulatory standards. A solid CAPA program is critical to sustaining long-term product quality as well. Maintaining compliance with globally recognized regulatory requirements FDA guidelines, ISO standards, etc. is particularly crucial.