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R Raghunandanan, Mumbai
Director ISPE India
26th February 2011
Agenda
Introduction
What, how and who in deviations
Types of deviations
Regulatory perspective
SOP for deviation handling
Process steps
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Introduction (1)
Medicines are different from any other
consumer products
End user of our products are patients, invalid,
infants, aged
They can not perceive quality, they accept
what you make and provide
They may be dealing with life and death
situation
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Introduction (2)
Thats why GMP standards are developed
GMP requires all processes / procedures to be
controlled
Any change from GMP must be justified,
approved and documented
Deviations are unplanned changes
Management of deviations is mandated by
GMP
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Process Step 1
The person who observes the incident / event
to notify the dept manager immediately
The incident / event recorded with adequate
traceability
Involve QA and decide if the event / incident
is a deviation or not
Evaluate the immediate impact or potential
impact on product quality, GMP and
compliance
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Process Step 3
The Dept Manager along with the QA
Manager to decide on the extent of Root
Cause Analysis required
Root Cause Analysis required if the impacts
are serious e.g. threat to patient safety,
severe product quality issues, major
regulatory non-compliance etc.
Root Cause Analysis required if deviation
happens recurrently
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Process Step 4
Establish team for doing Root Cause Analysis
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Process Step 5
Establish CAPA to eliminate the root cause
identified
Define actions and timescales
Follow up CAPA
Complete CAPA documentation
Close deviation
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Process Step 6
QA to periodically review the Deviation
Handling process
Carry out trending of deviations for the year
Process related
Equipment related
Procedure related
Summary findings discussed in Management
Review meetings
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Batch release
QA must approve each deviation and confirm
that all remedial actions have been
appropriately identified, agreed and
completed prior to batch release.
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Engineering involvement
If it is concluded that the deviation is due to
equipment / machinery failure then the Head
of Engineering should also be consulted for
taking any corrective or preventive actions
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Supplier involvement
If the deviation is attributed to a material
defect then this should be taken up with the
manufacturer (through Procurement) for
initiating any corrective actions as appropriate
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Responsibilities Observer
The Observer is the person who observed or
caused the incident / deviation
To record the incident accurately and
promptly
To take any immediate action to control the
incident
To notify the dept manager of the incident
observed
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Responsibilities QA
Decide along with the manager if the incident
or event is a deviation
Evaluate and approve the impact assessment
of the deviation
Assess the remedial action already taken
Classify the deviation after the results of the
investigation are known
Assess to what extent Root Cause Analysis is
required
Approve the investigation report and the CAPA
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Regulators comments
on deviation handling
Deviations handling is a hot topic for regulators
Some of the typical observations include
Deviations not documented as they occur
Reasons for deviations always human failure
No root cause identification for deviations
Investigation too scanty (no relevant details)
Deviations not included in batch records
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Questions
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