RR1 Posted April 20, 2009 Share Posted April 20, 2009 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 practicesthanks!Apex validation template v1.0 complete.docvalidation of cooler box.docvmp 72a.doc Link to comment Share on other sites More sharing options...
MT in ALB Posted April 23, 2009 Share Posted April 23, 2009 This are the templates that we use. Hope they help. If you make improvements, plese let me know.QA-519 V-1 Validation Protocol.docQA-519 V-2 Ver-B SOP Validation Checklist.docQA-519 V-3 Software Validation Protocol - 19 Jan 09.doc Link to comment Share on other sites More sharing options...
RR1 Posted April 27, 2009 Author Share Posted April 27, 2009 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 track1. Place agar plates at significant locations in the lab2. Get colony counts/ area3. Clean lab thoroughly .4. Place new agar plates and obtain colony counts5. 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!!!! Link to comment Share on other sites More sharing options...
L106 Posted April 28, 2009 Share Posted April 28, 2009 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 Link to comment Share on other sites More sharing options...
RR1 Posted April 28, 2009 Author Share Posted April 28, 2009 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. Link to comment Share on other sites More sharing options...
RR1 Posted May 4, 2009 Author Share Posted May 4, 2009 Interesting doc attached from Vox Sang.guidelines_for_validation_and_maintaining.pdf Link to comment Share on other sites More sharing options...
Eagle Eye Posted May 4, 2009 Share Posted May 4, 2009 This one is some where on this forum...But thanks. Link to comment Share on other sites More sharing options...
RR1 Posted May 5, 2009 Author Share Posted May 5, 2009 Another good WHO doc- nicely explained on validation and lots of templates.WHO validation.pdf Link to comment Share on other sites More sharing options...
RR1 Posted May 6, 2009 Author Share Posted May 6, 2009 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! Link to comment Share on other sites More sharing options...
pluto Posted May 7, 2009 Share Posted May 7, 2009 Thanks Rashmi for that infoMy heart skipped a beat when you had earlier mentioned Agar platesI like that KISS acronym never heard that one before Link to comment Share on other sites More sharing options...
Kitty Petershagen Posted May 26, 2009 Share Posted May 26, 2009 Would you mind sharing ?9.1 Change Control Form9.2 Change Control Policy (BT-POL-BT-004) Link to comment Share on other sites More sharing options...
RR1 Posted June 1, 2009 Author Share Posted June 1, 2009 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. Link to comment Share on other sites More sharing options...
RR1 Posted November 21, 2009 Author Share Posted November 21, 2009 (edited) 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, 2009 by RR1 Link to comment Share on other sites More sharing options...
RR1 Posted January 8, 2010 Author Share Posted January 8, 2010 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 Link to comment Share on other sites More sharing options...
LM1 Posted January 12, 2010 Share Posted January 12, 2010 here is our Change Control Procedure and FormCCP QAS.docCCF QAS.doc Link to comment Share on other sites More sharing options...
gshickman Posted January 13, 2010 Share Posted January 13, 2010 :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 practicesthanks! Link to comment Share on other sites More sharing options...
RR1 Posted January 13, 2010 Author Share Posted January 13, 2010 :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. Link to comment Share on other sites More sharing options...
RR1 Posted January 18, 2010 Author Share Posted January 18, 2010 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 versiongmp_annex_11_consult_200804.pdf Link to comment Share on other sites More sharing options...
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