Concept of

Deviation & CAPA at Analytical Lab in Pharma Industry

By

P. MUTHURAJ

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 Agenda
Deviation – Definition / Examples / Types / Category

Flow Charts – Planned & Unplanned Deviation / Laboratory Error Incident

Change Control – Definition & it’s Benefits

Types of Common Laboratory Incident – Errors / Investigation Checklist

Flow Chart – Laboratory OOS Investigation / Decision Tree Deviation – Categorization

CAPA – Definition / Examples / Benefits / 7 Cyclic Steps / Investigation Quality Tools

CAPA – Good Vs Bad / Regulatory Challenges / Common Issues / Fish Bone Diagram

Application of CAPA System Throughout the Product Lifecycle – ICH Q10

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 Deviation - Definition
Deviations are measured differences between observed value and expected or normal value for a

process or product condition, or a departure from a documented standard or procedure.

Deviation is a departure from approved procedure or established standard or specification.

A planned event required due to an unforeseen issue that is meant to keep control of the

process/product but which does not follow standard operating practices/procedures.

A deviation is an activity performed differently and/or modified than that specified in an approved

document.

A deviation may occur during sampling and testing, raw materials- and finished product

acceptance and manufacturing. 3

Deviations - Examples

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 Deviation - Types
There are two types of deviations : Planned Deviation & Unplanned Deviation.

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Flow Chart – Planned & Unplanned Deviation

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 Change Control – Definition & it’s Benefits
Change control is “A process that ensures the changes to material, methods, equipment and
software are properly documented, validated, approved and traceable”.

The assessment process of determining

the impact of the proposed change on
o Product quality,
o Safety,
o Quality Management System,
o Operating procedures,
o Environment and Personnel based on
the Risk Analysis.
classify as critical, major or minor.
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Laboratory Error Incident – Flow Chart

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Types of Common Laboratory Incident - Errors

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 Laboratory Incident – Investigation Checklist

# But not limited to 10

 Laboratory OOS Investigation – Flow Chart

Investigation – Phase - I

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 Laboratory OOS Investigation – Flow Chart

Investigation – Phase - II

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 Laboratory OOS Investigation – Flow Chart

Investigation – Phase - III

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Deviation - Categorization

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Decision Tree Deviation - Categorization

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 CAPA - Definition
 CAPA means “Corrective and Preventive Actions”

The CAPA defined as a systematic approach that includes actions needed to correct (correction),
avoid recurrence (Corrective action) and eliminate the cause of potential nonconforming product and
other quality problems (Preventive action).

Corrective Action : helps to eliminate the causes of a detected nonconformity or other undesirable
situation and should avoid the reoccurrence of the same issues.
Preventive Action : to eliminate the cause of a potential nonconformity or other undesired potential
outcomes.

Deviation Management is a subset of CAPA, Deviation management alone, while necessary, does
not correct problems. For this reason, CAPA involves
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Corrective Action vs Preventive Action

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CAPA - Examples

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CAPA - Benefits

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CAPA – 7 Cyclic Steps

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CAPA – Input Factors

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CAPA – Investigation Steps & Tools

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CAPA – Implementation & Effectiveness Checks

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Good CAPA vs Bad CAPA

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CAPA – Regulatory Challenges & Common Issues

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 Fish Bone Diagram - Attributes for Effective CAPA
Identification Impact / Risk Assessment Immediate Action

Effective
Outcome –
CAPA

Investigation – Quality Decision Action / Implementation

Root Cause
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Application of CAPA System Throughout the
Product Lifecycle- ICH Q10

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Seminar – Significance?

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Seminar – Really Impact?

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Seminar – Deviation & CAPA

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