Scribd
Upload
149 views1 page

Change Control Assessment Checklist

This check list outlines factors to consider when assessing changes to materials used in manufacturing processes. It separates factors into those relevant for non-critical materials versus critical materials. Critical materials require consideration of more factors like process validation, cleaning validation, equipment qualification, stability impact, testing requirements, regulatory impact, and downstream effects on customers.

Uploaded by

flong
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
149 views1 page

Change Control Assessment Checklist

This check list outlines factors to consider when assessing changes to materials used in manufacturing processes. It separates factors into those relevant for non-critical materials versus critical materials. Critical materials require consideration of more factors like process validation, cleaning validation, equipment qualification, stability impact, testing requirements, regulatory impact, and downstream effects on customers.

Uploaded by

flong
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

Appendix 5

Check List for Change Control Assessment

Non Critical Materials Critical Materials


Impact on site SOPs, batch documentation X X
etc.
Impact on supply X X
Training of personnel X X
Process validation X
Cleaning Validation X X
Equipment Qualification X
Safety X X
Environmental X X
TSE assessment X X
Stability Impact and the minimum period X
before release
Impact on testing of final product X
Extra testing for material received X X
Extra testing during production X
Extra testing requirements to assess the X
impact of the change
Regulatory impact on the filed product with X
all appropriate agencies.
 For new product, the filing strategy is
developed in partnership with research.
 For old product the filing may be needed
to be updated
Down stream impact on customers X

You might also like