Hi Folks,

if we could use this thread to post documents you are willing to share on validation: SOPs, Templates, tips ...whatever you have would be good. This will help us all improve practices

thanks!

Apex validation template v1.0 complete.doc

validation of cooler box.doc

vmp 72a.doc

This are the templates that we use. Hope they help. If you make improvements, plese let me know.

QA-519 V-1 Validation Protocol.doc

QA-519 V-2 Ver-B SOP Validation Checklist.doc

QA-519 V-3 Software Validation Protocol - 19 Jan 09.doc

Hi everyone,

Does anyone have a clue as to how to validate your cleaning procedure? I was going to do the following- but not sure if i'm on the right track

1. Place agar plates at significant locations in the lab

2. Get colony counts/ area

3. Clean lab thoroughly .

4. Place new agar plates and obtain colony counts

5. see if counts are reduced....but what level is acceptable?

is this going over the top?....I have to admit I don't really know how to do this !!!!

-would be a good problem to 'brainstorm'

suggestions please!!!!

Rashmi -

Does your facility have a person or department or committee that is in charge of "Infection Control" for your facility? If so, they should be the specialists that decide on the policies and procedures for the entire facility regarding cleaning protocols.

Donna

Thanks Donna, I'll try them, but I think I know what the response will be!!

It seems that a lot of folk don't understand the term validation as applied to cleaning of labs. The infection control teams are purely concentrating on patient areas and are not applying this to all areas.

Interesting doc attached from Vox Sang.

guidelines_for_validation_and_maintaining.pdf

This one is some where on this forum...But thanks.

Another good WHO doc- nicely explained on validation and lots of templates.

WHO validation.pdf

Further to my post on validated cleaning....it looks as though I was going over the top with suggestions of performing micro cultures for lab environments. After all, if something came up positive (as it inevitably would)- what actions would you then take ?

A reply I received from one of our BBT colleagues was nicely put as: " validation is proving that things work to your specification, you should validate that cleaning does occur on schedule .Perhaps a checklist of what needs to be cleaned/maintained according to a schedule"

So basically if you state how you are going to clean, and evidence it was performed and checked according to your procedure....and it looks clean!- should be OK.

Obviously this is only for blood banks that don't perform component processing and are not classified as 'clean rooms; as defined for pharmaceutical manufacturers.

I suppose the KISS technique applies to all this quality stuff (Keep It Short and Simple).

Thanks for all the info!

Thanks Rashmi for that info

My heart skipped a beat when you had earlier mentioned Agar plates

I like that KISS acronym never heard that one before

Would you mind sharing ?

9.1 Change Control Form

9.2 Change Control Policy (BT-POL-BT-004)

Hi Kitty,

I seem to be having problems uploading the change control policy (don't know why...as I have posted lots before). if you email me -I will send you a copy. My change control forms are currently being reviewed as they don't seem to be 'working' ideally for me. There are some other on this area of BBT, but once I have updated mine- I will forward these too.

On an annual basis (and after any significant changes) we need to re-qualify our main component storage equipment to ensure this is still fit for use. I had previously set up an incredibly complex template for checking the equipment against, for my poor staff to action. After having further thoughts about this, I have come up with a much simpler template (attached).

Is this how everyone else is doing this, am I on the right tracks ? all feedback, improvement suggestions etc would be very welcome!!

Qualification of Blood Component Storage Equipment.doc

Edited November 21, 200915 yr by RR1

Another useful document that was referred to me for the validation of computer systems in GXP regulated environments, from the www.picscheme.org website.

pi-011-3-recommendation-on-computerised-systems.pdf

here is our Change Control Procedure and Form

CCP QAS.doc

CCF QAS.doc

:tongue::)Thank you for the cooler validation procedures. It really helped me out a lot.

Hi Folks,

if we could use this thread to post documents you are willing to share on validation: SOPs, Templates, tips ...whatever you have would be good. This will help us all improve practices

thanks!

:tongue::)Thank you for the cooler validation procedures. It really helped me out a lot.

Thanks for your feedback, it's good to know we are all starting to use various documents on BBT to help. There are a lot more documents in the references section ( top bar), in the document library.

Another 'just for info' document: Eudralex draft version of the revised annex 11 GMP for computerised systems . Goes into a bit more detail than the current version

gmp_annex_11_consult_200804.pdf