I hope that you all can help me. I am currently responsible for the Sterilization Validation. We are doing Gamma Sterilization. My question pertains to a WI or SOP for the ongoing monitoring and validation status of products. I have to write this procedure and I am just looking for a little help. I have not found anything online to help guide. THis document would satisfy the requirements in 13485:2003 section 7.5.1.2.1. Any advice would be greatly appreciated.:thanx: :cfingers:

I hope that you all can help me. I am currently responsible for the Sterilization Validation. We are doing Gamma Sterilization. My question pertains to a WI or SOP for the ongoing monitoring and validation status of products. I have to write this procedure and I am just looking for a little help. I have not found anything online to help guide. THis document would satisfy the requirements in 13485:2003 section 7.5.1.2.1. Any advice would be greatly appreciated.:thanx: :cfingers:Do you mean the periodic revalidation of your sterilization process?

Do you mean the periodic revalidation of your sterilization process?

For Gamma Sterilization it would be Dose Auditing. YOu will have to forgive me I am not all that familiar with the process and I have no internal resources that is familiar with Gamma Radiation.

For Gamma Sterilization it would be Dose Auditing. YOu will have to forgive me I am not all that familiar with the process and I have no internal resources that is familiar with Gamma Radiation.That makes two of us, but have a look at what I found with Google.

I have seen that flowchart and what I was specifically looking for was how to document the requirments in my QMS.

I have seen that flowchart and what I was specifically looking for was how to document the requirments in my QMS.Let the "Guy" who owns the process write what "He" does, then you can make it nice!