Professional Documents
Culture Documents
Change Control
Change Control
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
16 | Nanjing, the People’s Republic of China, 16-20 November 2009
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
examples ⚫Change of ⚫Replacement of ⚫Change to
manufacturer: other apparatus part of the working times
synthesis route of a same design
starting material (other ⚫Installation of air
impurities) ⚫Change of cleaning conditioner in
agent for floors administrative
⚫Removal of processes area
to another site ⚫Change of laundry for
work clothes (non- ⚫Change in
⚫Change in the product sterile or antibiotics purchase
composition area) procedure
⚫ 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
34 | Nanjing, the People’s Republic of China, 16-20 November 2009
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