API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX

SOP Changes Training Drawing Qualification of Equip / Utility Pre approval from Regulatory body Change being effected intimation to reg Information to Annual update Stability Studies Approval from Reg Aff dept

A) Building of Mfg Block and ware house 1) Effecting Entry and gowning procedure 2) Effecting Utility system that are related to Quality attribute of product e.g HVAC,WATER etc 3) Effecting Man and Material movement 4) Effecting Equipment Layout with relocation of Equipment X X X X X X X

X X X

X X X X X X

X X X X

B) Building of QC C) Building of Microbiological Lab E) Manufacturing Equipment

X X

X X

API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX

SOP Changes Training Drawing Qualification of Equip / Utility Pre approval from Regulatory body X X X QC Instrument Critical Utility X X X X X X X X X X Change being effected intimation to reg X X Information to Annual update Stability Studies Approval from Reg Aff dept X

1 2 3

like to like Capacity Change Change Operating Principal

X X

DR PREM R GOEL BSc,B.Pharm,M.Pharm[India] MS,Ph.D[Pharma][USA]MBA[USA]MIQA[UK] drpremrgoel@gmail.com Skype:gaoposher goelngoelassociatesplc@gmail.com MSN MESSENGER :drpremrgoel1947@hotmail.com 00 91 7600134939 / 9327316198