Professional Documents
Culture Documents
Analytical
Laboratory for a
Regulatory Audit
Live Webinar
Paul Smith
paul_smith@agilent.com
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May 2, 2014
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May 2, 2014
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PREPARING YOUR ANALYTICAL LABORATORY
FOR A REGULATORY AUDIT
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Possible Audits You May Face
Laboratory
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Possible Audits You May Face
Environmental
Health &
Safety
Financial
Accreditation Body
ISO: Internal
13485 / 17025 / 9001 (Self-Audits)
Customs &
Excise Laboratory Customers
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Possible Audits You May Face
Environmental
Health &
Safety
Financial
Pharmaceutical
Regulatory
Accreditation Body
ISO: Internal
13485 / 17025 / 9001 (Self-Audits)
Customs &
Excise Laboratory Customers
Rules Applied
& Possible Actions..
Vary Between Audits.... Industries
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Possible Audits You May Face
Environmental
Health &
Safety
Financial
Pharmaceutical
Regulatory
Accreditation Body
ISO: Internal
13485 / 17025 / 9001 (Self-Audits)
Customs &
Excise Laboratory Customers
CORPORATE
(Sometimes the Hardest !)
Rules Applied
& Possible Actions..
Vary Between Audits.... Industries
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Possible Audits You May Face
Environmental
Health &
Safety
Financial
Pharmaceutical
Regulatory
Accreditation Body
ISO: Internal
13485 / 17025 / 9001 (Self-Audits)
Customs &
Excise Laboratory Customers
CORPORATE
(Sometimes the Hardest !)
Rules Applied
& Possible Actions..
But, many of the same principles apply to
Vary Between Audits.... Industries ALL AUDITS..
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Possible Audits You May Face Audits Preparation is
a Strategic Priority !
Customs &
Excise Laboratory Customers
CORPORATE
(Sometimes the Hardest !)
Rules Applied
& Possible Actions..
But, many of the same principles apply to
Vary Between Audits.... Industries ALL AUDITS..
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Compliance Drivers All Industries
Analytical Service
Commercial
Are Your Results Valid ?
Reasons
Compliance Reasons
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How Do You Know Your Results are Valid ?
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How Do You Know Your Results are Valid ?
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Managing The Audit What to Expect
Who Has Been in an FDA Audit ?
Official Role
Inspector
Host Broad
Knowledge
- stay with inspector
Fronter
Technical
Experts
Scribe - Subject
Runner Records
- Time asked
supplied
Gets what's
asked
(Info. / People)
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Managing The Audit What to Expect
Who Has Been in an FDA Audit ?
Strategic Role
Inspector
Reads
Host Inspector
Fronter Believable
Scribe
Runner Records
- Actions
issues..
Spy
(In Out)
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Managing The Audit What to Expect
Who Has Been in an FDA Audit ?
The Control Room is Staffed
by experienced personnel who:
Keep calm under pressure
Know site & company systems well
Documentation Experts
Audit
Control
Suppliers
Room
Inspector
Runner
Host
Information
Fronter
Scribe
Runner
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Managing The Audit What to Expect
Who Has Been in an FDA Audit ?
The Control Room is Staffed
by experienced personnel who:
Keep calm under pressure
Know site & company systems well
Documentation Experts
Audit
Control
Suppliers
Room
Inspector
Runner
Host
Information
Fronter
Scribe
Runner
Audit Decisions: Live Software Vs. Presentations / Simulated
FDA Now LIVE (Agilent is Supporting Customer FDA Audits)
Electronic or Paper Request System
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Managing Document Requests
Have to Remain Compliant During The Audit
With some inspections, such as the FDA, there may be SEVERAL
Inspectors
Original Approved Master Document provided to Inspectors
A. Debarment
People A. Training
B. Demographics
Suitable for Use ?
Equipment Life Cycle Management
Return to Use
Data Integrity
Data Life Cycle
Internal
Audits Observations
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Audit Preparation Focus Area..
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Audit Preparation Focus Areas + Data Integrity
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What did You Mean ?
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What did You Mean ?
Terms Used:
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TYPES OF AUDIT
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How The Audit is Performed.
Records Trace Pedigree / History
Hierarchical
Examine the Manufacturing Records
Examine the Lab. Results
Hierarchical Examine the Analyst Training Records
Examine the Instrument Details... Etc.
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How The Audit is Performed.
Records Trace Pedigree / History
Hierarchical
Examine the Manufacturing Records
Examine the Lab. Results
Hierarchical Examine the Analyst Training Records
Examine the Instrument Details... Etc.
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Kinds of Audit
Quality Management System
Is it Effective ?
Some Component
- Quality Mgt.
Early Observation.
ISO 9001 CAPA follow up
Emphasis Evaluate if Quality System is Effective for - SCOPE of ACCREDITATION
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Kinds of Audit
Quality Management System
Is it Effective ?
Some Component
- Quality Mgt.
Early Observation.
ISO 9001 CAPA follow up
Emphasis Evaluate if Quality System is Effective for - SCOPE of ACCREDITATION
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Kinds of Audit
Quality Management System
Is it Effective ?
Some Component
- Quality Mgt.
Early Observation.
ISO 9001 CAPA follow up
Emphasis Evaluate if Quality System is Effective for - SCOPE of ACCREDITATION
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Prepare Your People
Some inspectors
are HOSTILE,
The Future of
this site depends..
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Prepare Your People
People who talk to the auditor must:
An inspector will:
ASK you to describein your own words (to check you understand)
CHECK what you say Vs. the Standard Operating Procedure (SOP)
OBSERVE YOU doing the work
CHECK records of previous examples
CROSS-CHECK with other departments
ASK QUESTIONS
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Prepare Your People
Normally, we would..
To be honest..
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Prepare Your People
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Training
Personnel Training
Documented (Training File)
Background / Experience (CV / Resume)
GMP (Annual)
Job / Task Specific
Training Certificates
Testing of Knowledge (Demonstration of Understanding)
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INSTRUMENTATION
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4 Q Model for Instrument Qualification
Installation Performance
Qualification Qualification
DQ IQ OQ PQ
Design Operational
Qualification Qualification
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4 Q Model for Instrument Qualification
Does it Does it
Meet your USER Installation WORK as YOU Performance
REQUIREMENTS? Qualification EXPECTED? Qualification
DQ IQ OQ PQ
Design Has it been Operational Will it
Qualification INSTALLED Qualification CONTINUE to work
CORRECTLY? CORRECTLY?
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What will an Auditor Look at ?
What about:
- The future
What do you Re-Qualification
want it to do:
(Justification)
- Write it down
- Why is it suitable
IQ Maintenance
DQ Use
OQ
Breakdown
Does it Work:
- Installed correctly Re-Qualification Repair
- In your laboratory (Justification)
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What will an Auditor Look at ?
Audit Focus
What about:
- The future Is the Instrument
Suitable for use
What do you Re-Qualification Accuracy / Uncertainty
want it to do:
(Justification) Sensitivity / Science
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Laboratory Instrumentation .. Inventory Critical Instruments List
GC
HPLC
Dissolution
LC-MS
NIR
KF
pH Meters
Balances
. etc
List all your Critical Instruments
Review the Qualification Status /
History (Maintenance / System Log Book) of Each Instrument
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Laboratory Instrumentation .. Inventory Critical Instruments List
GC
HPLC
Dissolution
LC-MS
NIR
KF
pH Meters
Balances
. etc
List all your Critical Instruments
Review the Qualification Status /
History (Maintenance / System Log Book) of Each Instrument
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Laboratory Instrumentation .. Inventory Critical Instruments List
NIR
KF
Work Flow Mapping / Data Integrity Output to Source File
pH Meters Independent Data Integrity Review sample / check
Data Integrity Detection Training
Balances
. etc
List all your Critical Instruments
Review the Qualification Status /
History (Maintenance / System Log Book) of Each Instrument
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Laboratory Instrumentation. Status
What is Your
Does Your Laboratory Have These Rationale Any Strategy ?
[or their equivalent steps ?] - Monitoring Problems ? [about problems]
= Present X = Absent
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Laboratory Instrumentation. Status Decisions What do you do about
What is Your
Does Your Laboratory Have These Rationale Any Strategy ?
[or their equivalent steps ?] - Monitoring Problems ? [about problems]
= Present X = Absent
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Laboratory Instrumentation People / Contacts
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DATA INTEGRITY
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So, What is Integrity
Data Data Integrity ?
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So, What is Integrity
Data Data Integrity ?
Data
Data Traceability is Essential
In Data Integrity.
Sample
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Example Identification by FT-IR
Sample
Sample Preparation
Influences:
1. Spectrum Appearance
2. Variability [Skill]
3. Quality of Spectrum
[subjective decision]
USP
EP
Registration
Procedures
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Example Identification by FT-IR
Spectrum Quality:
[of the sample preparation not the identification]
Sample 1. Is the Quality of the sample
prep good enough ?
2. How managed / documented ?
[ OOS for sample prep. or procedure explaining
poor spectrum quality & how documented ]
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Example Identification by FT-IR
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Example Identification by FT-IR
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THE LABORATORY TOUR
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Plan The Lab. Tour
KF
Office
LIMS
HPLC
Fume
Write Up
Hoods
Write Up
Write Up
Sample
Receipt
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Plan The Lab. Tour
KF
Office
LIMS
HPLC
Fume
Write Up
Hoods
Write Up
Write Up
Sample
Receipt
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Plan The Lab. Tour
KF
Office
LIMS
HPLC
Fume
Write Up
Hoods
Write Up
Write Up
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Strategy For The Laboratory Tour
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Strategy For The Laboratory Tour
The investigator found a certificate of analysis (COA) for (b)(4) oz, lot number (b)(4),
dated January 19, 2011, in a trash container in the office used by QC personnel
ucm311326
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Questions ?
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Thank You!
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APPENDIX
ADDITIONAL INFORMATION
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During The Audit
These
Are Discussed The site will WORK on these
OOS At the Daily Issues - to try and get them
CAPA Wash Up off the chart.
Etc
Establishment
Flip Chart Inspection Warning
Report (EIR) Letter
Wall Chart..
Form 483
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Compliance - A Service Providers Perspective.
We have never had a problem with Data Integrity is a different kind of audit
our paper qualification in audits before, A good audit is good news for a site, but a perfect
so why should consider moving to audit may not be ideal - as its harder to justify
electronic now ? investment do you ever find that a problem ?
How do you justify new equipment / improvements
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Who Owns The Audit Preparation ?
IN OUR AUDIT
PLAN
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Example Sample Life Cycle. Electronic Vs. Paper
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Laboratory Instrument Check List
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Knowledge Management
Data Structure
Data
Data
Data Experience
Data Information
Data
Knowledge
Store
Search Organise
Meaning Apply
Decisions
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What Questions Will The FDA Ask Software ?
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