17025 Accredited Microbiological Testing Laboratory

[Emine]

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

 

[indubioush]

Did you validate the test method? You maybe need to perform revalidation with the new media. However, if you can show that the media is equivalent, you might not have to do the revalidation.

 

[John C. Abnet]

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.

 

[Emine]

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