GXP

Implementing an Effective CAPA Program at the Contract Laboratory

Introduction Our objective is to identify problems in a timely manner, to correct them and to prevent their re-occurrence.  As a corollary to this, we want to foresee potential issues and ward them off before they become real.  The ultimate goal is for the laboratory operation to become self-correcting.   To be successful, management has put into place a corrective-and-preventative actions (CAPA) system. Any CAPA system must work effectively and its “effectiveness” must be measured. It must also work efficiently.  The CAPA program itself should not become a problem. ...

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