I am with API industry.

At present my task is to prepare and perform the facility qualification.

Did anybody have a template or input for performing the Facility Qualification.

Thanks
Regards/Raghu

Hi Raghu,

You are going to have to be a lot more specific if you want a comprehensive answer as the term "facility" can mean anything: What kind of facility? What is it designed to do? What are its operating parameters? etc...

The more information you can provide the greater degree of tailoring the respondent(s) can offer.

Jimmy

The objective of the facility or premises qualification is as follows:

Premises is designed, constructed, adapted and maintained to suit the operations to be carried out.

The layout and design must aim to minimise the risk of errors and to permit effective cleaning and maintenance in order to prevent/avoid cross contamination, buildup of dust/dirt and in general any adverse effect on the quality of the product

Additional info: The qualification is a retrospective one (!), since

1. Ours is a running API-facility which is recently acquired
2. Previously facility qualification was not carried out.

Hope this will help me

Thanks
Regards / Raghu

Hi Raghu,

Facility Qualification is usually referred to the qualification of the utilities like HVAC, Water, Compressed Air and so on.

I think you want a template of Site Master Validation Plan, right ?

Raghu,

You could also use the "Site Master File (SMF) (http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con007557.pdf)" as recommended by World Health Organization (WHO) and other regulators like MHRA.

This is a great document and you could include the Qualification and Validation requiurements in it too :)

Ajit,

Many Thanks for the SMF guideline.

In the mean time I have prepared one checklist (for our self inspection) based on ICH guideline which is very similar to the SMF guideline. (Please find the attachment)

While I go through our requirements the approach is very similar to the approach what we have followed for our equipment qualification and I didn’t see any difference.

I thought that there will be a different approach when we do qualification for facility.

At present what I am planning is to go through with the attached checklist and to create evidence during the qualification exercise.

Is this the acceptable practice?

Kindly pass your comments to proceed further.

Thanks,

Regards / Raghu

Attachment is missing in my previous reply.

Pls. find the attachment here.

Regards / Raghu

Ajit,

Many Thanks for the SMF guideline.

In the mean time I have prepared one checklist (for our self inspection) based on ICH guideline which is very similar to the SMF guideline. (Please find the attachment)

While I go through our requirements the approach is very similar to the approach what we have followed for our equipment qualification and I didn’t see any difference.

I thought that there will be a different approach when we do qualification for facility.

At present what I am planning is to go through with the attached checklist and to create evidence during the qualification exercise.

Is this the acceptable practice?

Kindly pass your comments to proceed further.

Thanks,

Regards / Raghu

Its perfectly fine ... continue using and you can fine tune it later.:)

Thanks. Will update once the facility qualification is completed.

Regards / Raghu