Best Practices to Implement an Effective Change Control Program Company Wide

BEST PRACTICES TO IMPLEMENT AN EFFECTIVE CHANGE CONTROL PROGRAM COMPANY WIDE

MIMI VIRLANY SYAHPUTRI

INTRODUCTION

IVT Singapore - 27 Feb 2012Syahputri2012-All Rights Reserved

2

SINGAPOREBUKIT BATOKNATURE RESERVE PARK

WHAT IS CHANGE CONTROL?Free definition :

Systematic approach to managing all changes made to a product or system

What GMP Guidance/Regulation says?CGMP concept : Managing change to prevent unintended consequences.

Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval (21 CFR 314.70, 514.8, and 601.12). (US-FDA : Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations )


3

WHAT IS CHANGE CONTROL?

• What GMP Guidance/Regulation says? (cont’d)– Change Management System through

out Product Life Cycle– Risk Based Approach

(ICH Q10 : Pharmaceutical Quality System)


4

Pharmaceutical

Development

Technology Transfer

Commercial Manufacturin

g

Product Discontinuati

on

WHAT IS CHANGE CONTROL? Procedures shall be established and maintained

for making changes to a process. Any such change shall be verified or validated to ensure that change does not create an adverse impact (Current Good Tissue Practices – 21 CFR 1271 sec 1271.225: Process Changes)

Making uncontrolled changes is a violation of several sections of the QSR (Quality System Regulatron, including section 820.30, 820.40, 820.70, 820.75 and 820.181 (Change control procedure section, QSR Manual, FDA.gov home page)

These written procedures, including any changes shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the Quality Control Unit (Subpart F – 21 CFR 211.00 Production and process control unit)


5

WHO WILL BE RESPONSIBLE FOR CHANGE CONTROL SYSTEM

System is owned by Quality

Implementation of the system :All employee


6

WHEN TO USE CHANGE CONTROL

If the change may impact to Registered/Critical Parameter Validated/Qualified state Direct Impact to Product Quality

Attribute Non-Direct Impact to Product Quality

but control must be in placed


7

WHEN TO USE CHANGE CONTROL

Non-Direct Impact to Product Quality but control must be in placedI.E.o Under work order with QA oversight oro Under change control system (Categorized as

minor type change)o Document Management System

Focus : Change Control System To manage non routine change


8

DEFINE OR IMPROVE THE CHANGE CONTROL SYSTEM


9

CHANGE CONTROL STEPS

Initiation Evaluation

Approved for

execution

Implementation Closure


10

APR

Investigation

Inspection

Further Improvement

Product/System/Process/Facility Utility

history

HOW TO IMPLEMENT AN EFFECTIVE CHANGE CONTROL :


11

Define/Improve

• Mapping• Review current process• Grouping• Set up Hierarchy• Set Change Categorization

Set-up System

• SOP• FORM• Database

Implementation

•Training•Monitoring/Improvement

CHANGE CONTROL

Provides : Traceability Historical data Measure of accountability Control variation Improve product reliability and customer

satisfaction Protect patient from unintended

consequences


12



13

Define/

Improve

• Mapping• Review current

process• Grouping• Set up Hierarchy• Set Change

Categorization

MAP ALL SYSTEM/PROCESS

Before defining/improving system :

Map the processes/systems

Time consuming but worth


14


Facility/Utility : Routine maintenance work (spare part replacement) Non Routine maintenance work

Site Change : New product transfer/launch

Laboratory : New Instrument New Method

Manufacturing/Equipment : Manufacturing process


15


Mapping will help us to understand : Process Existing System that controlling the

process (i.e electronic batch record, SAP Production Version Control, etc.)

The criticality of each process/system To minimize redundancy Differentiate main change vs action of

change


16


Change Description :“Update Manufacturing Instruction from version A to version B”

Reason for change :“Change on IPC range specification from X1-Y1mm to X2-Y2mm


17

What the first thing pop up in your mind if you receive this kind of change proposal?

MAP ALL SYSTEM/PROCESSProduct Transfer

BOM Change

ManufacturingInstruction

Change

Cleaning Portfolio Change

Analytical Method Creation


18

Product Transfer

MI Change

Analytical Method

BOM Change

Cleaning Portfolio

VS


POINT TO REMEMBER :IMPROVING CHANGE CONTROL SYSTEM IS NOT MERELY ABOUT :

CUT PROCESS STEP SIMPLIFY PROCESS REMOVE WASTE


19


IT IS ABOUT : ROBUST“There is no easy way to properly control changes to devices, processes, device master records, etc. Change Control is a complex process. Failure to have an adequate change control system can cause equally “complex results”

(Introduction section, QSR Manual, FDA. Gov home page)


20



21

Define/

Improve



Categorization

REVIEW CURRENT CHANGE CONTROL

Assess current change control system against the outcome from mapping of current process


22

REVIEW CURRENT CHANGE CONTROLAssess all change control that had been issued How many change proposal annually? :

hundreds? Criticality : was all critical? Did we treat

all the same effort? Did we find recurrence change

proposal? Were we raising change control for routine task?

How many outstanding change control ?


23

REVIEW CURRENT CHANGE CONTROL

Review your procedure from 1st version of SOP till the current one.

Was the improvement that had added proactive/reactive?

How to simplify it


24

REVIEW CURRENT CHANGE CONTROL Does the SOP have proper guidance to

perform impact assessment/evaluation

Is the form user friendly (too much free text field or lack of important information)

Is the data base sufficient to track back the historical data?

Is routine refreshment training available?


25



26

Define/

Improve



Categorization

SYSTEM/PROCESS CHANGE GROUPING• Apply risk based approach (Q09 – Quality

Risk Management)Change management / Change control• To manage changes based on knowledge and information

accumulated in pharmaceutical development and during manufacturing

• To evaluate the impact of the changes on the availability of the final product

• To evaluate the impact on product quality of changes to the facility, equipment, material, manufacturing process or technical transfers

• To determine appropriate actions preceding the implementation of a change, e.g., additional testing, (re)qualification, (re)validation or communication with regulators


27

SYSTEM/PROCESS CHANGE GROUPING

Ideally one change control system for all system : Product related change (process,

material, equipment Facility/Utility Supplier Analytical method Etc.


28

SYSTEM/PROCESS CHANGE GROUPINGManufacturing Plan with complex systems and with interface increase the complexity of Change Control System

i.e.: Simple change : “like for like change” Change due to typographical Change with significant impact : “increase

batch size, equipment change” Do you want to use same “bullet” to hit above

“targets”?


29

SYSTEM/PROCESS CHANGE GROUPINGHow to group? Reason for change

Must/Nice to have

System wise (i.e. IT Change Control, Direct product impact change, Technical Change (Facility, Utility), Lab Change

Complexity (Level of Impact)

Regulatory/Non-regulatory impact

Note : Initial assessment must be in place to control whether the change may give direct impact to product/quality, and conquered by Quality person


30


i.e. : Change to SCADA system which could

impact equipment recipe control

Manage under product related change


31


Note : Initial assessment must be in place to control whether the change may give direct impact to product/quality, and conquered by Quality person


32

Flow


33



34

Define/

Improve



Categorization

SET-UP CHANGE CONTROL SYSTEM HIERARCHIES

Change system grouping is applied:Provide guidance/policy/high level

SOP explaining the hierarchiesGive an overview to change

management systemProvide the link among systems


35

SET-UP CHANGE CONTROL SYSTEM HIERARCHIES (EXAMPLE)

Policy/Guideline

Change Management High Level

Document/Procedure

Operational Procedures

Forms


36



37

Define/

Improve



Categorization

CHANGE CATEGORIZATION(TYPE, COMPLEXITY, IMPORTANCE/URGENCY)

Change Control Type : Help us on trending, traceability To put similar type of change together

i.e. : Equipment change, supplier change, material (API and excipient) change, etc.

Give management overview for assessment and evaluation for future improvement


38


Change Control Complexity Potential impact Risk implication on

product/process/end user/ and quality system

Risk based approach define degree of evaluation and approval


39


Can be defined based on : Level of impact to product/process/end

user and quality system Investment Resources

Risk Analysis tools : FMEA RPN (Risk Priority Number) Fault Tree Analysis Etc.


40


Importance/Urgencyo Why we need to change this?

o Business driven (improvement, cost saving, etc.)

o Compliance driven (compulsory)o Help on resource and time allocation –

managing change is non routine activities


41

CHANGE CATEGORIZATION

• Simple Change Complexity categorization :


42

Major Moderate Minor

Investment more than S$ 50,000.00

Isolated for one or multiple products

Involve one or multiple product

Full qualification/validation

Partial qualification/validation

No qualification/validation required (simple IQ/Commissioning only)

Impact Regulatory/ registration parameter

Direct impact to Product Quality/Critical Parameter

No direct impact to product/critical parameter

Direct impact to Product Quality/Critical Parameter

Impact to packaging site No direct impact to packaging site

Impact to packaging site Involve 2 or more department

Involve 3 or more department

CHANGE CATEGORIZATION

Highly recommended : Change control review board for

change with multiple impact (Major change)

Group of people from different department, Quality Representative, Subject matter expert (SME), Management team (Decision maker)


43

SET-UP CHANGE CONTROL SYSTEM


44


Establish standard operation procedures

Workflow and detail. Form user friendly

Not too much flex-field/less informative

Database


45


SOP : > 1 Change Management System 1 SOP

Change Management (High level) and its operation SOPs

Workflow is preferred together with the responsible person information


46


FORM : Too much tick box standardize on input,

but less informative Too much flex-field More informative

(depend on initiator), may vary from one initiator to another

Must be balance


47


FORM :Minimum Flex-field :

Short description of the changeChange descriptionCurrent state and future proposed stateJustification, Business Case and Risk

AssessmentEvaluation from related impacted area


48


FORM : Must capture :

• Impacted system/equipment/utilities/facilities• Impacted document• Impacted material and its lot number• Initiator• Assignee name for the actions• List of actions• Date of QA Approval for change execution• Date of implementation• Date of Closure


49



50


FORM : List of actions :

Must be in sequence To understand and define prerequisite action list

before implementation (ICH Q9) To avoid overlooking actions that may be

required before change can be implemented.

Recent HA question during audit : How do you know that any proposed change ready for implementation?


51



52


Change Description :“Batch size scale-up of XYZ FCT from 300kg to 500kg”

Question :Could you list down the pre-requisite actions before the change can be started to implement?


53


Database :Excel, Ms Access, Customized

Database system, etc.To facilitate :

TrackingTrendingReporting


54

ESTABLISH GUIDELINE

SOP :Include guidance :

To define the urgency/importanceComplexity (i.e Major, Moderate, Minor)

SystemImpact assessment


55



56

Reason of Change

Quality/HA

Compliance?

HSE

Must

Possible Plant Shutdown

Business Continuity

Production Process Stop

Process Improvement

Business Improvement/

Economy Productivity

Cost Saving

ESTABLISH GUIDELINE


57

Change Type ExampleREGULATORY CHANGE TYPE

REG LAB IT TECHNICAL

Facilities and Utilities Introduce new facilities Site Change X

Introduce new utilities - X

Change on existing facilities Site Change X

Change on existing utilities - X

Changes in Computer systems and software which may have an impact on system validation, product quality or GXP

Change in Computer system and software which impact directly to the product

- X

Change in Computer system and software which impact indirectly to the product

- X

ESTABLISH GUIDELINE(IMPACT ASSESSMENT)


58

Poison License

Environmental

MonitoringQualificati

onProcess

ValidationCleaning Validation

Testing Method AMT/AMV Master

PlanQuality

Agreement

Lab Worksheet P&ID QRA Training Manufacturin

g Lisence

Product formulationChange API/excipient to different API/excipient

X X X X X X X X

Change total on composition X X X X X X X

Change on discharge composition but does not change total composition

X X X X X X X

Manufacturing process

Total change on manufacturing process concept (i.e wet granulation to direct compression

X X X X X

Change on manufacturing step process (non-registered/registered item)

X X X X X X X

ESTABLISH GUIDELINE

NOTE : By having guidance does not mean :

everything become black and white

Space for discussion in change control committee board, or during evaluation phase

At least : give the initiator a hint!


59

IMPLEMENT THE CHANGE CONTROL SYSTEM


60

CREATE INTERACTIVE TRAINING

1st : System introduction and detail explanation

2nd : Hands-on training : Attendee need to fill in the form with case

study (in groups) Cross check the correctness among groups

3rd : Assessment 4th : Periodic Refreshment Training (i.e.

every 4 months, 6 months)


61

MONITORING AND CONTINUOUS IMPROVEMENT

Monitoring on : Effectiveness on procedure/process Number of Change control annually (Open,

closed, outstanding) To be evaluate and assess in periodic

management review meeting/Internal Audit program

Gather feedback for improvement


62

SUMMARY : Understand the process/system

Define how would you like to set your change control system based on process/system (one for all/grouping)

Categorize it (risk based approach)

Establish robust procedure with guidance

Establish user friendly and informative form

Establish robust data base

Set up an effective training program

Establish monitoring for continuous improvement


63

KEY ON DEFINE/IMPROVE CHANGE CONTROL

Gather feedback from the users Get team together to review current

process/system Training is a key in Change Control

system Compliance come first

IVT Singapore - 27 Feb 2012

Syahputri2012-All Rights Reserved64

THANK YOU FOR YOUR ATTENTION

ANY QUESTION?


65

Best Practices to Implement an Effective Change Control Program Company Wide

Documents

Transcript of Best Practices to Implement an Effective Change Control Program Company Wide