API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX SOP
Training
Drawing
Effecting Man and Material movement
Effecting Equipment Layout with relocation of Equipment
B) Building of QC
X
X
X
X
X
X
X
X
C) Building of Microbiological Lab
X
X
X
X
X
Changes
A) Building of Mfg Block and house 1)
2)
3)
4)
Pre approval from Regulatory body
Change being effected intimation to reg
X
X
X
Information to Annual update
Stability Studies
Approval from Reg Aff dept
ware
Effecting Entry and gowning procedure Effecting Utility Utility system that are related to Quality attribute of product e.g HVAC,WATER etc
E) Manufacturing Equipment
Qualification of Equip / Utility
X
X
X
X
X
X
X
X
X
X
X
API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX SOP
Training
Drawing
X
X
Changes
1
like to like
2
X
Change Operating Principal
QC Instrument
Critical Utility
Change being effected intimation to reg X
X
X
X
Pre approval from Regulatory body X
Information to Annual update
Stability Studies
Approval from Reg Aff dept
X
X
X
Capacity Change
3
Qualification of Equip / Utility
X
X
X
X
X
X
X
X
X
X
DR PREM R GOEL BSc,B.Pharm,M.Pharm[India] MS,Ph.D[Pharma][USA]MBA[USA]MIQA[UK]
[email protected] Skype:gaoposher
[email protected] MSN MESSENGER :
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