Change Control

Importance & Management.

Ajmal Nasir Ph.D

Director Technical

BF Bioscineces Ltd Lahore

PAKISTAN

OBJECTIVE
To Discuss The Importance Of Change Control, Requirement And Effective Management.

DEFINITION
A CHANGE IS ANY VARIATION THAT MAY IMPACT CONSISTENT PRODUCT QUALITY.
Variation Can Be In Documentation, Equipment, Packaging, Utilities, Facilities, Formulations, Process Or Computer System. The Change May Or May Not Impact The Safety, Quality, Purity Or Potency Of A Product Throughout Its Shelf Life

INITIATIVES TO CHANGE
Change is the end result of initiatives for Quality Management and Continuous improvement. Objective of Change is
Improving Quality Increasing Yield Reducing Costs Cutting Waste Streamlining

Processes Etc.

CLASSIFICATION OF CHANGE

Change is of two Types:

Temporary

Can be a planned or un planned

deviation.
Permanent

Result of three planned and approved deviations agreed by all stake holders.

CLASSIFICATION OF CHANGE
There are three level of Change:
High :

Very likely to impact the product.

Somewhat likely to impact the

Medium :

product
Low :

(Emergency changes) Anticipated to have no or a negligible impact on the product.

Change Level indicates the possible impact to the product.

Why a Change Control

One Of The Most Critical Element In A

Pharmaceutical Or Biotech Company's Quality Management System.

Huge Risk Of Non Compliance If Not

Adequate.
The FDA's Guidance For Industry, EU

Orange Guide , ICH Guidelines Etc. Clearly Reinforces The Importance Of Implementing An Effective Change Control Procedures As A Critical Component In An Overall Quality System .

Change Control is Done For

Advance Determination of

issues Related to Required Change. Decision on required Validation or Qualification Possibilities. In time Preparation or Updating of SOPs / Documents . Structured Training program for all Concerned. Smooth sailing of the CHANGE

Possible Proposed or

WHO CAN INITIATE CHANGE

Any Body In The Organization Can

Initiate. Must Be Reviewed and Approved By The Sectional Head And All Other Sections Involved The Activity Shall Be Controlled By QO Formal Review Of Change Control Request. Formal Approval / Rejection By All Concerned.

What IS Required ?
A Formal System By Which Qualified Representatives Of Appropriate Disciplines Review Proposed Or Actual Changes That Might Affect The Validated Status Of Facilities, Systems, Equipment or Processes That Would Ensure And Document That The System Is Maintained In A Validated State
EU guidance on GMP - Qualification and Validation (Annex 15 of the 'Orange Guide' page 185)

PROGRAM DESIGN
The Program Must Manage The End-toEnd Change Control Process Including:
Initiating Reviewing Approving Training Distributing

Storing Change History.

PROGRAM SCOPE
The Change Control Program Must Cover A Broad Set Of Possibilities Including
Formulation Product Design, Manufacturing

instructions
SOPs,
Test methods Specifications, New raw materials Changes in Policy.

Facilities,
Utilities Equipment Computer systems,

PROGRAM MUST
Provide Compliance Capture Relevant Information

For The Objective ,Nature &Scope Of CC.

Provide Traceable History of

Changes in Quality and Systems

System Schematic
Identifies The Need For Change Assesses impact of the proposed change

Approves the change

Implements change

Assess (reviews) the change [follow-up]

Impact Assessment
For Impact analysis we shall consider
Risk Associated to the Change Which SOPs and documents will be affected Impact on other Departments Training required before the Change

implementation

Risk Assessment
Should be performed by a person or Committee understanding Process and expert in Transfusion.
How Bad

What Can Go Wrong

Action Needed?

Frequency?

RISK MATRIX
CONSEQUENCES
CRITICAL MAJOR MODERATE MINOR NEGLIGABLE RARE UNLIKELY POSSIBLE LIKELY ALMOST CERTAIN

LIKELIHOOD

WHAT WE NEED TO MANAGE CHANGE CONTROL

A Company

-wide Change Control

System

HISTORY Maintenance Of Changes For

Audit Trail Purposes(Most Important Aspects )

A Structured

Approach Towards

Managing Change In An Environment Focused On Continuous Improvement.

How system should be

A Concrete System Capable To Manage The End-to-end Change Control Process Must Include :
Initiating, Training Maintaining Change

Reviewing,

Approving, Distributing

History
Evidence To Compliance

Must Helps To Capture Relevant Information About The Objective, Nature And Scope Of Change.

Approach Shall Be

KISS
Keep It Simple Stupid

ELEMENTS OF GOOD SYSTEM

A company wide System

Owner Ship at all levels

List of Change Control Items Formal Review ,Risk analysis,

approval/ Rejection Simple Forms and Pathway An efficient and Quick System Proper Training and Distribution Archiving of History Formal Close out

What Is The Difference Between Deviation And Change Control? At What Situations We Can Raise The Deviation And Change Control

Deviation is temporary and it is two

types one is planed deviation another is un-planed deviation. Un-planed deviation occurs suddenly. Change control is a proposal that change in any process, equipments or method. But it approved the comments of all department which are related to this change.