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Change Control System Change Control System Change Control System

This document discusses change control systems for pharmaceutical companies. It defines change control as a formal system by which qualified representatives review proposed or actual changes that could affect validated facilities, systems, equipment, or processes. The goal is to determine if changes need to be made to ensure systems remain validated. It distinguishes between deviations, which are temporary changes, and actual changes, which are permanent procedure modifications. It provides examples of areas requiring change management and discusses how change control committees assess risks, classify changes, and conduct feasibility studies. Major changes influence quality or reliability while minor changes influence controlled units. Changes needing revalidation include raw materials, packaging, processes, equipment, production areas, and facility relocations. The benefits of change control include improved system

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Behrouz Rostampour
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46 views

Change Control System Change Control System Change Control System

This document discusses change control systems for pharmaceutical companies. It defines change control as a formal system by which qualified representatives review proposed or actual changes that could affect validated facilities, systems, equipment, or processes. The goal is to determine if changes need to be made to ensure systems remain validated. It distinguishes between deviations, which are temporary changes, and actual changes, which are permanent procedure modifications. It provides examples of areas requiring change management and discusses how change control committees assess risks, classify changes, and conduct feasibility studies. Major changes influence quality or reliability while minor changes influence controlled units. Changes needing revalidation include raw materials, packaging, processes, equipment, production areas, and facility relocations. The benefits of change control include improved system

Uploaded by

Behrouz Rostampour
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 13

Change Control

System
for pharmaceutical companies

November 2013

1
What is change control?
According to Annex 15 of EU GMP Guideline:
“ A formal system by which qualified
representatives of appropriate disciplines review
proposed or actual changes that might affect
validated status of facilities, systems, equipment
or processes.
The intent is to determine the need for action that
would en-sure and document that the system is
maintained in a validated state.”

2
What is the difference between change
and deviation?

Deviation is a temporary
planned or unplanned change.
But the actual change is a
permanent procedure exactly.

3
For example if your standard batch size is 200
kgs, if u want to increase the batch size from
200 kgs to 250 kgs at this time first u have to
raise a planned deviation. After successful
completion of the 3 batches QA will evaluate the
results and shall decides whether the batch size
shall be incorporate in the process. After getting
the approval the concerned personnel
(Department) shall raise the change control for
the batch size changes.

4
Raiser of a change:
Everybody who works
That means the raiser of a change can
be member of any department

5
Areas requiring change management:

Automation
Process Equipment Documents
Systems Materials Batch

Packaging Hardware/ Regulatory And


/Labels
network/
changes EHS Governances
applications others

EHS: Environment, Health and Safety

6
Change Control Committee(CCC):

All companies’ managers can be a member of


CCC due to QA manager’s viewpoint.

7
What are they do in CCC?
Risk assessment of future change
Classification of change
Feasibility study

8
Classification:
Major changes : Are the changes which influence
product quality or process reliability.
Minor changes : Are the changes that influence a
unit requiring control.
Not requiring control: Are the changes which have
no effect on GMP or authorization.

9
Examples:
Major : Change in process parameters
Minor : Change of cleaning agent for floors or
replacement of apparatus of the same design.
Not requiring control : Change in working time or
renovations of administration area.

10
Changes which needs revalidation:
Physical characteristics of the raw materials.
Origin of starting materials.
Packaging material.
Process changes.
Equipments.
Production area and supply system.
Moving manufacturing into a new building.

11
Change control advantages:
The statistics for the annual changes can give a
good view for the system reliability.
Decrease work expenditure.
Lower the process time.
Reduction of internal or external complaints.
And so on …

12
Thank you for your patience

13

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