17025 Accredited Microbiological Testing Laboratory

#1
Hi All,

We are a microbiological laboratory and we want to change the media we use (we want to change the manufacturer only) for a test method. What we need to do? I would appreciate if you could help me on how we can perform verification before switching to new media?

Many Thanks
 
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John C. Abnet

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#3
Hi All,

We are a microbiological laboratory and we want to change the media we use (we want to change the manufacturer only) for a test method. What we need to do? I would appreciate if you could help me on how we can perform verification before switching to new media?

Many Thanks
Good day @Emine
Here are some considerations...
1- Is there a consensus or customer or internal standard that requires a specific media? (if so, does the new media meet this requirement?)
2- Does/do your customer(s) have a change point control requirement? (i.e. do you have any requirement to gain prior approval of any proposed changes?).
3- Does this constitute a deviation from original customer contract(s) ? (If so...7.1.4 ~ 5 may apply)
4- As @indubioush mentioned, validation of the change is likely required (review all of clause 7.2).

Hope this helps
Be well.
 
#4
Good day @Emine
Here are some considerations...
1- Is there a consensus or customer or internal standard that requires a specific media? (if so, does the new media meet this requirement?)
2- Does/do your customer(s) have a change point control requirement? (i.e. do you have any requirement to gain prior approval of any proposed changes?).
3- Does this constitute a deviation from original customer contract(s) ? (If so...7.1.4 ~ 5 may apply)
4- As @indubioush mentioned, validation of the change is likely required (review all of clause 7.2).

Hope this helps
Be well.
Hi @John C. Abnet,
Your response was very helpful, thank you very much. By answering each questions above, now we know what we need to do next :)
Emine
 
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