Equipment Gap Analysis and remediation plan


(Joanna) #1

Hello there,

What is the more important thing in review of an existing Validation Documentation (Equipment)?
I have identified gap assessment, and released that many reports have not been found, many reports have not been executed to current GMP standard. Now I am working on Remediation Plan, and I am not sure what to include to make an Auditor happy, as we have decided to revalidate all 250 pieces of the equipment.

I will be grateful to get some hints and a little help.

Best regards,
Joanna
Validation Officer


(Pragnesh) #2

Better to raised the Deviation, include in it.
Perform Risk assessment of the Gap you found, categorize them and accordingly prepare remedial plan, may be in some equipment you need to revalidate few things and in some you need to perform 100%.
Also it will be easy to justify the auditor as well as products which were already manufactured at what extent it may have impact on quality.


(DeepakMishra) #3

Agree with Pragnesh. Raise Deviation, investigate the cause of failures. Risk assessment, impact assessment to be performed and wherever required requalification to be performed.