INTERNAL AUDITS OF LABORATORIES

Sanjay S Shetgar
1

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

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
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 investigations

22%

Chromatographic
data

20 %

Management

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
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
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
in-process 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

S.N
o

Typical Checklist for

Equipment Observati
Checks
ons
Y / N / NA

Is there a system to have a unique code for

each piece of equipment

Are the equipment placed in a environment

as per its need and is there a status log
available ?

Are there SOPs which define the calibration

and maintenance of the equipment ?

Are calibration and maintenance schedules

adhered to ?

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

Comme
nts

Template Audit Report

Audit Number :
Department :
Date(s) of audit :
Auditors :
Scope of Audit :
Type of
Audit :
---------------------------------------------------------------------------------------------------------------------------------------------------Executive Summary :
Lead Auditor :
( Sign / Date )
Sl.n NonClassifica Agreed
Responsi Status
________________________________________________________________________________________________

conformance

tion

Correctiv bility /
e and
Date
Preventiv
e Action

Open /
Closed

__________________________________________________________________________________________
Audit Closure Statement :
Head Quality ( Sign/Date) :
________________________________________________________________________________________________

QUESTIONS