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Change Control Matrix For Facility Change

This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

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Prem Goel
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713 views

Change Control Matrix For Facility Change

This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

Uploaded by

Prem Goel
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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] [email protected] Skype:gaoposher [email protected] MSN MESSENGER :[email protected] 00 91 7600134939 / 9327316198

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