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2.0
3.0
4.0
Purpose
1.1
1.2
Scope
2.1
2.2
Responsibility
3.1
3.2
Department
operations
documented
engaged are
SOPs.
3.3
Procedure
4.1
4.2
SOPs must reflect the actual and current practices for that
procedure.
4.3
4.4
4.5
4.6
4.7
4.8
4.9
Definitions
4.9.1 Scope :
It shall describe who and what the procedure does and
does not apply to and/or when it is applied. The scope of a
SOP declares the extent of the procedure described.
4.9.2 Responsibility :
It shall declare the individuals and/or department who take
responsibility for executing or supervising this activity.
4.9.3 Reagents and Chemicals :
In general, reagents and chemicals shall be consistent
throughout all SOPs, use common universal terms and
include pertinent information such as concentration and
sterility.
GMP ASEAN GUIDELINE