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

Syahputri2012-All Rights Reserved IVT Singapore - 27 Feb 2012

INTRODUCTION

SINGAPORE
BUKIT BATOK
NATURE RESERVE PARK

2


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 GMP Guidance/Regulation says?
(cont’d)
– Change Management System through out
Product Life Cycle
– Risk Based Approach Pharmaceutical
(ICH Q10 : Pharmaceutical Quality System) Development

Product Technology
Discontinuation Transfer

Commercial
Manufacturing
4


 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 placed
I.E.
o Under work order with QA oversight or
o 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

Approved
Implementat
Initiation Evaluation for Closure
ion
execution

APR

Investigation

Inspection

Further Improvement

Product/System/Process/
Facility Utility history
10


HOW TO IMPLEMENT AN EFFECTIVE CHANGE
CONTROL :
• Mapping
• Review current process
Define/ • Grouping
• Set up Hierarchy
Improve • Set Change Categorization

• SOP
Set-up • FORM
System • Database

• Training
Implementation • Monitoring/Improvement

11


CHANGE CONTROL

Provides :
 Traceability

 Historical data

 Measure of accountability

 Control variation

 Improve product reliability and customer
satisfaction
 Protect patient from unintended consequences

12


CONTROL :

• Mapping
• Grouping
Define/ • Set up Hierarchy
Improve • Set Change
Categorization

13


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
What the first thing pop up in your mind if you receive
this kind of change proposal?
17


Product
Transfer
Product
BOM Change
Transfer MI
Change

Manufacturing Cleaning
VS Analytical
Instruction Portfolio
Change
Method
Change

BOM
Analytical Change
Method
Creation
Cleaning
Portfolio

18



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


CONTROL :

• Mapping
• Grouping
Categorization

21


REVIEW CURRENT CHANGE CONTROL

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

22


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

 Wasthe improvement that had added
 proactive/reactive?

 How to simplify it

24



 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


CONTROL :

• Mapping
• Grouping
Categorization

26


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



Ideally one change control system for all
system :
 Product related change (process, material,
equipment
 Facility/Utility

 Supplier

 Analytical method

 Etc.

28


Manufacturing 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


How 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


CONTROL :

• Mapping
• Grouping
Categorization

34


SET-UP CHANGE CONTROL SYSTEM HIERARCHIES

 Change system grouping is applied:
 Provideguidance/policy/high level SOP
explaining the hierarchies
 Give an overview to change
management system
 Provide the link among systems

35


SET-UP CHANGE CONTROL SYSTEM HIERARCHIES
(EXAMPLE)

Policy/Guideline

Change Management High
Level Document/Procedure

Operational Procedures

Forms

36


CONTROL :

• Mapping
• Grouping
Categorization

37


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
 Potentialimpact
 Risk implication on product/process/end
user/ and quality system
 Riskbased 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/Urgency
o 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


• Simple Change Complexity categorization :
Major Moderate Minor
Investment more than S$ Isolated for one or multiple Involve one or multiple
50,000.00 products product
Full qualification/validation Partial qualification/validation No qualification/validation
required (simple
IQ/Commissioning only)
Impact Regulatory/ Direct impact to Product No direct impact to
registration parameter Quality/Critical Parameter product/critical parameter

Direct impact to Product Impact to packaging site No direct impact to
Quality/Critical Parameter packaging site
Impact to packaging site Involve 2 or more
department
Involve 3 or more
department
42


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


SET-UP CHANGE CONTROL SYSTEM

 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 change
Change description

Current state and future proposed state

Justification, Business Case and Risk
Assessment
Evaluation 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 :
Tracking

Trending

Reporting

54


ESTABLISH GUIDELINE

 SOP :
Include guidance :
Todefine the urgency/importance
Complexity (i.e Major, Moderate, Minor)

System

Impact assessment

55


Reason of Change

Quality/HA
Compliance?
HSE
Must
Possible Plant Shutdown
Business Continuity
Production Process Stop

Process Improvement

Business Improvement/ Productivity
Economy

Cost Saving

56


ESTABLISH GUIDELINE

REGULATORY TECHN
Change Type Example REG LAB IT
CHANGE TYPE ICAL

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
Change in Computer system and
which may have an
software which impact directly - X
impact on system
to the product
validation, product
quality or GXP

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

57


ESTABLISH GUIDELINE
(IMPACT ASSESSMENT)

Environmental Monitoring

Manufacturing Lisence
Cleaning Validation
Process Validation

Quality Agreement
Testing Method
Poison License

Lab Worksheet
Qualification

Master Plan
AMT/AMV

Training
P&ID

QRA
Change API/excipient to different
Product formulation 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
Total change on manufacturing
process concept (i.e wet
granulation to direct compression
Manufacturing process

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

58


ESTABLISH GUIDELINE

 NOTE :
 Byhaving guidance does not mean : everything
become black and white

 Spacefor 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 Reserved
64


THANK YOU FOR YOUR ATTENTION

ANY QUESTION?

65

Best Practices to Implement an Effective Change Control Program Company Wide

More Related Content

What's hot

Similar to Best Practices to Implement an Effective Change Control Program Company Wide

Best Practices to Implement an Effective Change Control Program Company Wide

Editor's Notes