Cleaning validation

Quality Assurance
1

What are the tests performed for chemical swab sample and micro swab sample???

2

The tests to be performed on swab samples collected during cleaning validation are specified in the Cleaning validation protocol.
The chemical tests include quantitative determination of carry over residue(s) of previous product API, and impuritie(s), toxic compund(s), excipient(s) if any.
The microbiological tests include Total bacterial & fungal count and objectionable micro-organisms (pathogen if any).
These results are to be corelated with the ‘Acceptance criteria’ defined in the cleaning validation protocol.

3 Likes
3

Thanks for responding,
And what is the limit for rinse and which test is carried out for rinse.

4

Hello. I’m new to pharmaceutical company. How do we determine acceptance criteria? and what are the microbiological medium used for the test?

5

if I have two products and I want to carry out cleaning validation
what should I do?

6

Go back to your reference pharmacopeia they wrote all the limits

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