INTERNAL AUDITS OF LABORATORIES
Sanjay S Shetgar
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Quality Systems Guidance
Quality System
• The requirements of a good Quality System are no
more than common sense and good business
practice
• A comprehensive pharmaceutical quality system
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Management Involvement for resource and review
Promotes a lifecycle approach to product quality.
Promotes innovation and continual improvement.
Provides opportunity to optimize regulatory processes.
Typical Quality Management Review
• Critical / Major audit findings and status of
closure ( Regulatory / Internal )
• Trends and Status of Quality Indicators like
Deviations, Non-conformances, OOS,
Complaints, Environment, Rejections
• Product / facility / personnel issues if any
• CAPA status
• Major change controls
Audits
It is a systematic and independent
examination to determine whether or not the
quality activities and related results comply
with planned arrangements and whether
these arrangements are implemented
effectively and are suitable to achieve the
objective.
These can be formal or informal , random and
unannounced.
Why Audits
Why is there a need to audit ?
• Health of Quality System
• Identify gaps and avoid potential big problems
• Mitigate risk
• Simplification and better allocation of resources
• Continuous improvement
• Assurance to management
• Audit ready at all times
Requirements
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Carried out by trained and qualified personnel
Personal preferably independent of activity being audited
Set the scope for the audit
Divide laboratory based on risk and audit one by one each
of the identified area
Use of checklist
Documentation
Develop Corrective and Preventive actions
Escalation and review by Management
Follow up for effectiveness check
Periodic Audit
Auditing
• What a auditor should know
- Finding will not be in a open platter to pick up
- You have to search for it ( or else auditee would
have anyway identified )
• Look at type of findings from previous audits.
• Evaluate and check where the maximum number
of observations are seen however small
• Concentrate on this area during the audit
Example of Plan ( Cont.)
Category of observation
Observations
Personal related
5%
Standard Maintenance
8%
Specification and test
methods
5%
Calibration and
Preventive maintenance
20 %
Method validation
5%
Out-of-specifications and 22%
investigations
Chromatographic data
20 %
Management Reviews
15 %
Calibration, OOS, and
Chromatographic Data
areas would require
priority reviews
Methods
• Develop a plan for the audit right from start to end
( including a start up meeting and close up meeting )
• Draw up a checklist Typical Checklist for Equipment
• Questions should be – open ended as far as possible
• Observe behavior and body language and tone of speech
• Make the auditee feel at home
• Listen
• Collect facts and relate it to the committed practice
• Make a audit report that is Clear, Concise, Complete,
Concrete and Courteous.
• Classify the observations into categories of nonconformances based on findings
• Communicate the findings to management. Template Audit
Report
Expectations on Good Laboratory
Practices as part of Schedule L-I
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Effective 1st November 2010
This rule makes specific mention and controls in following areas
General Requirements
Premises
Personnel
Equipment
Chemical & Reagents
Good House keeping and Safety
Maintenance, calibration and validation of equipment
Reference materials
Microbiological cultures
Quality Systems
Internal Quality System Audits
Management Reviews
SOPs
Protocols and Specification Archive
Raw Data
Storage and Archival
Frequent Warning Letter Citations
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Laboratory Testing and Controls – 40 %
Validation and Qualification – 20 %
Inadequate Investigations – 20 %
Quality Unit Approval and Oversight - 10%
Documentation and Recordkeeping - 10 %
Typical Observations
Laboratory Testing and Controls
General Laboratory Controls
• Failure to perform system suitability testing
• Failure to re qualify reference standards
• Failure to follow USP test methods
• Laboratory computer system security
• Use of common passwords
• Reassignment of administrator privileges (to
modify and delete data) to other laboratory
personnel
Typical Observations
Stability Testing
• Failure to establish a stability indicating test
method
• Failure to have an approved stability protocol
• Failure to follow protocol requirements
• Failure to perform stability testing
Typical Observations
Validation and Qualification
• Failure to validate and/or qualify
- Analytical test methods
- Laboratory computer systems
- Manufacturing equipment and laboratory
instruments
Typical Observations
Validation and Qualification
• Failure to maintain specifications for
equipment qualification
Drawings
• Purchase orders
• Failure to re qualify equipment after
modification
Typical Observations
Quality Control Unit (QCU)
• No SOP defining the responsibilities of the
QCU
• QCU not fulfilling responsibility to ensure
product quality and GMP compliance
Typical Observations
Quality Control Unit (QCU)
• Inappropriate QCU release
• Releasing products with failing results
• Releasing products based on satisfactory
retest results without an investigation
• Releasing products made with
microbiologically contaminated raw and inprocess materials, based on satisfactory final
product testing results
Typical Observations
Quality Control Unit (QCU)
• Failure to detect errors in batch records
• Approval of batches with inaccurate and
incomplete test results
• Allowing failing products to remain in
distribution
• Failure to investigate deviations and test
failures
Typical Observations
Recordkeeping and Documentation
• Failure to document at the time of
performance
• Inadequate master and batch record
instructions and documentation
• No documentation for component weighing
• No time limits for aseptic processing
Typical Observations
Recordkeeping and Documentation
No documentation for:
• In-process test results
• Quality control unit release
• Investigations
• Calibration
• Microbiological media preparation and growth
promotion
Typical Checklist for Equipment
S.No
Checks
1
Is there a system to have a unique code for each piece of
equipment
2
Are the equipment placed in a environment as per its
need and is there a status log available ?
3
Are there SOPs which define the calibration and
maintenance of the equipment ?
4
Are calibration and maintenance schedules adhered to ?
5
Is there are a check on equipment suitability after a
modification?
-Do such modifications go through a change control
process
- Is there a mechanism to capture history of the
equipment
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Is there a system to indicate defective equipment ?
- Are they calibrated prior to next use ?
Observations
Y / N / NA
Comments
Template Audit Report
Audit Number :
Department :
Date(s) of audit :
Auditors :
Scope of Audit :
Type of Audit :
----------------------------------------------------------------------------------------------------------------------------------------------------Executive Summary :
Lead Auditor :
( Sign / Date )
________________________________________________________________________________________________
Sl.no Non- conformance
Classification Agreed
Corrective
and
Preventive
Action
Responsibilit
y / Date
Status
Open /
Closed
__________________________________________________________________________________________
Audit Closure Statement :
Head Quality ( Sign/Date) :
________________________________________________________________________________________________
QUESTIONS