In general, the activities required for the development and validation of a Standard Operating Procedure are:
Definition of objectives
Design of the experimental activities program
Execution of experimental tests
Sampling and analysis of samples
Statistical analysis of data
Writing of the SOP and its validation.
Here is a diagram of how the various phases of the activities could proceed:
where is it:
DP = Development Protocol
DOP1 = Operating development procedure # 1
ELot1 = Experimental production of batch # 1
DA # 1 = Analysis of lot # 1 data
DOP2 = Operating development procedure # 2
ELot2 = Experimental production # 2
DA # 2 = Analysis of lot # 2 data
DOP3 = Operating development procedure # 3
ELot3 = Experimental production # 3
DA # 3 = Analysis of the data of lot # 3
DR = Development report
SOP = Standard Operating Procedure (to be validated)
VP = Validation Protocol of the Standard Operating Procedure
VLot # 4 = Fourth lot produced and first batch of validation
DA # 4 = Data analysis on the first batch of validation
VLot # 5 = Fifth lot produced and second validation lot
DA # 5 = Data analysis on the second batch of validation
VLot # 6 = Sixth batch produced and third lot of validation
DA # 6 = Data analysis on the third lot of validation
VR = Validation Report of the SOP