change control 1

8/3/2019 Change Control 1

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Ajmal Nasir P h. DDirector TechnicalBF Bioscineces LtdLahorePAKISTAN

Change Control

Importance & Management .


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OBJECTIVETo Discuss TheImportance Of

Change Control,Requirement

AndEffective Management.


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DEFINITIONA 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 ProductThroughout Its Shelf Life


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INITIATIVES TO CHANGEChange is the end result of initiatives for QualityManagement and Continuous improvement .

Objective of Change is

Improving QualityIncreasing Yield

Reducing Costs

Cutting Waste

Streamlining

Processes Etc .


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Change is of two Types:Temporary

Can be a planned or un planneddeviation.

PermanentResult of three planned and approved

deviations agreed by all stake holders.

CLASSIFICATION OF CHANGE


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CLASSIFICATION OF CHANGEThere are three level of Change:

High : Very likely to impact the product.

Medium : Somewhat likely to impact theproduct

Low : (Emergency changes) Anticipated tohave no or a negligible impact on the product.Change Level indicates the possible

impact to the product .


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Why a Change ControlOne Of The Most Critical Element In APharmaceutical Or Biotech Company'sQuality Management System.

Huge Risk Of Non Compliance If NotAdequate.

The FDA's Guidance For Industry, EUOrange Guide , ICH Guidelines Etc. ClearlyReinforces The Importance OfImplementing An Effective Change ControlProcedures As A Critical Component In An

Overall Quality System .


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Change Control is Done ForAdvance Determination of Possibleissues Related to Proposed orRequired Change.

Decision on required Validation orQualification Possibilities.In time Preparation or Updating of

SOPs / Documents .Structured Training program for allConcerned.

Smooth sailing of the CHANGE


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WHO CAN INITIATE CHANGEAny Body In The Organization CanInitiate.Must Be Reviewed and Approved By TheSectional Head And All Other SectionsInvolvedThe Activity Shall Be Controlled By QO

Formal Review Of Change ControlRequest.Formal Approval / Rejection By All

Concerned.


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What IS Required ?A Formal System By Which Qualified

Representatives Of AppropriateDisciplines Review Proposed Or Actual

Changes That Might Affect The Validated Status Of Facilities, Systems,

Equipment or Processes That WouldEnsure 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)


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PROGRAM DESIGNThe Program Must Manage The End-to-

End Change Control ProcessIncluding:

Initiating

Reviewing

Approving

Training Distributing

Storing Change History.


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PROGRAM SCOPE The Change Control Program MustCover A Broad Set Of Possibilities Including

Formulation

Product Design,

Facilities,

Utilities

Equipment

Computer systems,

Manufacturing

instructionsSOPs,

Test methods

Specifications,

New raw materials

Changes in Policy.


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PROGRAM MUSTProvide Compliance

Capture Relevant Information ForThe Objective ,Nature &Scope OfCC.

Provide Traceable History ofChanges in Quality and Systems


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System Schematic

Assess (reviews) the change [follow-up]

Implements change

Approves the change

Assesses impact of the proposed change

Identifies The Need For Change


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Impact Assessment

For Impact analysis we shallconsiderRisk Associated to the Change

Which SOPs and documents will be affected

Impact on other Departments

Training required before the Change

implementation


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Risk AssessmentShould be performed by a person or

Committee understanding Process andexpert in Transfusion.

How Bad

Action

Needed?

Frequency?

What Can

Go Wrong


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RISK MATRIX

CRITICAL

MAJOR

MODERATE

MINOR

NEGLIGABLE

RARE UNLIKELY POSSIBLE LIKELY ALMOST CERTAIN

CONS

QUEN

C

LIKELIHOOD


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WHAT WE NEED TO MANAGECHANGE CONTROL

A Company -wide Change ControlSystem

HISTORY Maintenance Of Changes ForAudit Trail Purposes(Most ImportantAspects )

A Structured Approach TowardsManaging Change In An EnvironmentFocused On Continuous Improvement.


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How system should be

Initiating,

Reviewing,

Approving,

Distributing

Training

Maintaining Change

History

Evidence To Compliance

Must Helps To Capture Relevant Information About

The Objective, Nature And Scope Of Change.

A Concrete System Capable To Manage The End-to-endChange Control Process Must Include :


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Approach Shall Be

KISS

Keep It SimpleStupid


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ELEMENTS OF GOOD SYSTEM

A company wide SystemOwner Ship at all levelsList of Change Control Items

Formal Review ,Risk analysis,approval/ RejectionSimple Forms and PathwayAn efficient and Quick SystemProper Training and DistributionArchiving of HistoryFormal Close out


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What Is The Difference Between DeviationAnd Change Control? At What Situations WeCan Raise The Deviation And Change Control

Deviation is temporary and it is twotypes one is planed deviation anotheris un-planed deviation. Un-planed

deviation occurs suddenly.Change control is a proposal thatchange in any process, equipments or

method. But it approved the commentsof all department which are related tothis change.


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