erniel
25th December 2007, 10:27 PM
I am beginning to put together a CAPA program for a small pharmaceutical company. I have found a lot of CAPA forms available in the forums but i cannot locate any SOP's related to a CAPA program. Would anyone be willing to share their procedures for a comprehensive program that will comply with 21CFR 211. Any help is appreciated
Ajit Basrur
26th December 2007, 12:16 AM
Hi,
Got the following presentation and guideline from the internet. You could follow the methodology defined in the presentation and guideline and adopt as per your organization structure and records.
The MS PowerPoint could also be used as training material.
Another example of SOP for CAPA is HERE (http://onnp.ebme.case.edu/qsdraft/QS/QPR/CAPA/SOP/QS-QPR-CAPA-SOP-01%20Corrective%20and%20Preventive%20Action%20Procedure.doc)