A remedial action, in this context, should be defined as the process of providing a change to non-conforming products, manufacturing processes, and company policies in order to properly address those deficiencies. This action (or actions) should be executed under a comprehensive plan that will later confirm effectiveness. Remediation Plans that are well planned and executed should effectively bring products and company to acceptable levels of GMP compliance.
The sooner these remediation plans are designed, and actions executed, the better chance your company will have to remain open and minimize losses, even if a recall operation is involved.
The best approach to take is by organizing lines of actions in individual CAPA investigations. A comprehensive CAPA investigation will identify and investigate existing and potential products, processes and quality problems. This approach will serve to your Quality Unit to initiate the investigation(s) and put in motion a set of actions to eliminate nonconformities on systems, processes or products, and to later verify their non-recurrence.