Classification of Changes
|
CHANGE
|
MINOR |
||||
Initiating Dept. |
QAM |
Regulatory
|
R&D / PDL
|
Head
- QA / RA
|
|
|
Grammatical / Language /
Re-phrase (Editorial Changes)
|
Sign
|
Sign
|
Notify
|
NA
|
Sign |
|
Format
|
Sign
|
Sign
|
Notify
|
NA
|
Sign |
|
Minor
changes in analytical procedure
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign |
|
Cleaning
Procedure
|
Sign
|
Sign
|
Notify
|
NA
|
Sign |
|
Safety
Instructions
|
Sign
|
Sign
|
NA
|
NA
|
Sign |
|
SOP
|
Sign
|
Sign
|
NA
|
NA
|
Sign |
|
Stability
Protocol
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign |
|
Equipment
change of location (same)
|
Sign
|
Sign
|
Sign
|
NA
|
Sign |
|
Printed
Label change
|
Sign
|
Sign
|
Notify
|
NA
|
Sign |
|
Drawing
(s), Utility Drawings, lay outs etc.
|
Sign
|
Sign
|
Notify
|
NA
|
Notify |
|
Computer system change / software change
|
Sign
|
Sign
|
NA
|
NA
|
Notify |
|
CHANGE
|
MAJOR |
||||
Initiating Dept. |
QAM |
Regulatory
|
R&D
|
Head
- QA / RA
|
|
|
Formula Change
|
Sign
|
Sign
|
Notify
|
Sign
|
Sign
|
|
Source Change of key RM
|
Sign
|
Sign
|
Notify
|
Notify
|
Sign
|
|
Primary packaging material
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign
|
|
BPCR / Batch Formula / Batch Size /
Master manufacturing
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign
|
|
Site Master File
|
Sign
|
Sign
|
Sign
|
Notify
|
Sign
|
|
Equipment (different)
|
Sign
|
Sign
|
Notify
|
Notify
|
Sign
|
|
Major change in the Process, like
change in solvent.
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign
|
|
Change in Analytical Method like
change from TLC to HPLC.
|
Sign
|
Sign
|
Notify
|
Sign
|
Sign
|
|
Specification
|
Sign
|
Sign
|
Sign
|
Notify
|
Sign
|
|
Parameter
|
Sign
|
Sign
|
Sign
|
Sign
|
Sign
|
|
RM & PM Supplies (Vendor)
|
Sign
|
Sign
|
Notify
|
NA
|
Sign
|
|
Required Process Change
|
Sign
|
Sign
|
Notify
|
Sign
|
Sign
|
Sign Sign required
Notify Notify
NA Not Applicable
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