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Change Control: Luisa Stoppa
Change Control: Luisa Stoppa
Luisa Stoppa
This principle is not only valid the first time a medicinal product is
manufactured or the first time a facility is used or a procedure
comes into effect
QM change
statement policy
EU-GMP
Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, the People’s Republic of China, 16-20 November 2009
16 |
Change control programs
Major change Minor change Not requiring
control
The example is one
Significance Influences product Influences a unit No relevance to
way to rate them: of change quality or process requiring control GMP or
reliability authorization
Possible Official license Amendment
No relevance to
measures GMP or
(selection) New approval Review
authorization
revalidation documentation
Other
classifications are
possible
WHO-GMP
WHO-GMP guidelines
Changes Deviations
)planned changes( )unplanned changes(
PIC/S guideline
The team should also deal with all changes whose grade
or implementation is unclear or questionable
EU-GMP
Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, the People’s Republic of China, 16-20 November 2009
34 |
Documentation
WHO-GMP
Change control
procedure
(example 1)
Change control
procedure (example
2, 2/2)
Change Activities
Approval Approval
Activities Activities
Completion Completion
Change Closed
Change control
procedure: flow
chart (example 4)
Change control
procedure: flow
chart for change
master documents
(example 1)
Change request
form (example 1,
1/2)
Change request
form (example 1,
2/2)
Change request
form (example 2,
1/2)
Change request
form (example 2,
2/2)
Change request
form (example 3)
Change database:
electronic copy